DAILY RELEVANT REGULATORY NEWS

INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

Aprovada lista dos grupos homogéneos e dos preços de referência unitários - 4.º trimestre de 2019

A lista dos Grupos Homogéneos e dos preços de referência unitários a vigorar no 4.º trimestre de 2019 foi aprovada.

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  • 17-09-2019
EMA - European Medicines Agency

EMA to review ranitidine medicines following detection of NDMA

 

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  • 16-09-2019
Ordem dos Farmacêuticos

Novo regulamento para gerir disponibilidade de medicamentos em Consulta Pública

O Infarmed colocou em Consulta Pública um novo projeto de regulamento para gerir a disponibilidade de medicamentos, um documento que vem definir as regras e procedimentos para notificação de faltas ou ruturas de medicamentos, bem como as obrigações dos titulares de autorizações de introdução no mercado, dos distribuidores grossistas e farmácias.

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  • 13-09-2019
ICH

The ICH E17 Guideline training materials available now on the ICH website

The ICH E17 Guideline on General Principles for Planning and Design of Multi-Regional Clinical Trials was finalised under Step 4 in November 2017. This Guideline provides guidance on general principles on planning/designing Multi-Regional Clinical Trial (MRCT).

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  • 12-09-2019
ECA - European Compliance Academy

Track & Trace: Still ongoing issues

It has hardly worked out anywhere: the falsification protection project has not been properly adapted EU-wide and discontentment is spreading amongst pharmacists.

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  • 11-09-2019
European Comission

Final version of the Guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic, toxic to reproduction or have endocrine-disrupting properties

 

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  • 10-09-2019
FDA - Food and Drug Administration

FDA Offers Advice on Benefit-Risk Considerations for Device Submissions

“The continuous, robust generation of evidence throughout the premarket and postmarket setting … is important to continuously refine our understanding of how medical devices are used and perform,” the agency said.

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  • 09-09-2019
Ordem dos Farmacêuticos

Amazon vende milhares de produtos inseguros ou proibidos

De acordo com uma investigação recente, a Amazon está a vender pelo menos 4.152 produtos que foram incorretamente identificados, proibidos ou declarados como inseguros pelas autoridades nacionais.

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  • 06-09-2019
FDA - Food and Drug Administration

Orchestra BioMed Receives CE Mark for Implantable Hypertension Treatment

The principal investigator said the device has potential as a primary treatment for hypertension.

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  • 05-09-2019
ECA - European Compliance Academy

EMA publishes first two Guidances on Drug Shortages

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) published two guidance documents which can be seen as foundation for a long way to diminish shortages of medicinal products.

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  • 04-09-2019
FDA - Food and Drug Administration

PhRMA Applauds FDA’s New Review Template for New Drug, Biologic Applications

PhRMA said it “strongly encourages” the FDA’s new “integrated review process,” which combines assessments by the agency’s different disciplines into a single document for new drug applications and efficacy supplements.

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  • 03-09-2019
EMA - European Medicines Agency

Global public meeting on draft ICH guideline on clinical trials

The ICH E8 guideline sets out general scientific principles for the conduct, performance and control of clinical trials. In recent years, clinical trials have undergone a radical transformation with a wider range of both trial designs and data sources being used in drug development. Therefore, ICH initiated a revision of the E8 guideline to address all the aspects that were not covered by the current version of the guidance.

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  • 02-09-2019
UK Government

Hormone replacement therapy (HRT): further information on the known increased risk of breast cancer with HRT and its persistence after stopping

New data have confirmed that the risk of breast cancer is increased during use of all types of HRT, except vaginal estrogens, and have also shown that an excess risk of breast cancer persists for longer after stopping HRT than previously thought. Prescribers of HRT should discuss the updated total risk with women using HRT at their next routine appointment.

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  • 30-08-2019
FDA - Food and Drug Administration

Statement on the agency’s ongoing efforts to resolve safety issue with ARB medications

Protecting patients is the FDA’s highest priority, and Americans can be confident in the quality of the products the agency approves. The recent Angiotensin II Receptor Blocker (ARB) recalls have deeply concerned patients, the medical community, the agency and international regulatory bodies. The FDA is aware many patients rely on ARB medicines, and we are concerned about the presence of nitrosamine impurities in these drugs. Millions of people benefit from the high-quality products that the FDA regulates, and the U.S. has the most robust drug supply in the world, with strict standards for safety, effectiveness and quality.

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  • 29-08-2019
FDA - Food and Drug Administration

White House Highlights ‘Red Flags’ for Illicit Fentanyl

The manufacturing advisory identifies the various stages of illegal fentanyl manufacturing and distribution.

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  • 28-08-2019
ECA - European Compliance Academy

What are suitable Cycles for Re-Qualification?

With the revision of Annex 15 in October 2015, the topic of requalification has become more important. Time intervals for the assessment of the equipment with regard to the qualification status and for the requalification itself should be justified. Criteria for the assessment should be defined. This is sometimes difficult. Chapter 9 of the revised ISPE Baseline No 5 Commissioning & Qualification of June 2019 on the periodic review can be helpful here.

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  • 27-08-2019
FDA - Food and Drug Administration

U.S. Urges EU to Delay Implementing EU MDR/IVDR by Three Years

The letter highlights the lack of notified bodies in the EU to perform certification activities under the MDR/IVDR.

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  • 26-08-2019
EMA - European Medicines Agency

New measures to avoid potentially fatal dosing errors with methotrexate for inflammatory diseases

 

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  • 23-08-2019
EMA - European Medicines Agency

Questions and answers on the exemption from batch controls carried out on ATMPs imported into the European Union from a third country

 

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  • 22-08-2019
ECA - European Compliance Academy

What is a Combination Product?

The FDA released a final guidance on postmarketing safety reporting for combination products to further clarify what a combination product is and how applicants can comply with the rules on postmarketing safety reporting requirements (PMSR).

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  • 21-08-2019
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

Alterações ao Estatuto do Medicamento reforçam regulação e supervisão no circuito do medicamento

Entrou em vigor o Decreto-Lei n.º 112/2019, de 16 de agosto, que constitui a décima segunda alteração ao Decreto-Lei n.º 176/2006 de 30 de agosto, diploma que aprova o denominado Estatuto do Medicamento.

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  • 20-08-2019
EMA - European Medicines Agency

EMA/FDA analysis shows high degree of alignment in marketing application decisions between EU and US

EMA and the US Food and Drug Administration (FDA) are aligned in more than 90% of marketing authorisation decisions for new medicines. 

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  • 19-08-2019
Diário da República

Decreto-Lei n.º 112/2019 - Diário da República n.º 156/2019, Série I de 2019-08-16123962150

Altera o regime jurídico dos medicamentos de uso humano 

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  • 16-08-2019
EMA - European Medicines Agency

EMA closed 15 August 2019

 

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  • 14-08-2019
ECA - European Compliance Academy

How to detect Falsified Medicines

Falsified medicines repeatedly occur in the supply chain. The MHRA now provides information on how to detect them.

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  • 13-08-2019
EMA - European Medicines Agency

What’s new in pharmacovigilance - QPPV Update - Issue 1 - 2019

 

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  • 12-08-2019
EMA - European Medicines Agency

Updated reminder on the working documents provided within the eCTD submissions

As per the structure of the eCTD, the product information should be provided in PDF format within Module 1.1.3. However, occasionally it is necessary to provide, in addition to the PDF requirement, product information or the Module 2 documents in Word format. These files should be provided outside of the eCTD structure, in a separate folder called xxxx-workingdocuments on the same submission zip package as the eCTD.

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  • 09-08-2019
UK Government

Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) in a no-deal Brexit

Pharmacovigilance system requirements if there is a no-deal Brexit.

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  • 08-08-2019
EDQM

11 new reference standards and 28 replacement batches released in July 2019

The EDQM announces the availability of: 11 new Ph. Eur. reference standards; 28 replacement batches for Ph. Eur. reference standards. Information on reference standards removed from catalogue. Information on change of sales units. Information on changes of storage / shipping conditions. Information on reference standards currently out of stock. 

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  • 07-08-2019
ECA - European Compliance Academy

Is the Audit Trail Review required for Electronic Health Records?

MHRA´s GCP inspectors have recently seen various types of Electronic Health Records (eHRs) during their investigator site inspections and in several cases they have given major findings.

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  • 06-08-2019
Ordem dos Farmacêuticos

Governo aprovou alterações ao Estatuto do Medicamento

O Governo aprovou em Conselho de Ministros uma alteração ao Decreto-Lei n.º 176/2006, que estabelece o regime jurídico dos medicamentos de uso humano, no sentido de “minimizar as situações de rotura de medicamentos no território nacional”.

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  • 05-08-2019
Ordem dos Farmacêuticos

Comissão Europeia disponibiliza novos documentos para implementação dos regulamentos europeus de dispositivos médicos e para diagnóstico in vitro

A Comissão Europeia tem vindo a disponibilizar vários documentos orientadores para facilitar a implementação dos novos regulamentos europeus dos Dispositivos Médicos (DM) e dos Dispositivos Médicos para Diagnóstico In Vitro (DIV). Dirigidos aos diferentes intervenientes do ecossistema dos DIM e DIV, estes documentos, alguns dos quais em versão traduzida para português, são disponibilizados pelo Infarmed, na área do site dedicada à implementação dos novos regulamentos.

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  • 02-08-2019
EMA - European Medicines Agency

Names of liposomal medicines to be changed to avoid medication errors

 

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  • 01-08-2019
ECA - European Compliance Academy

How to quickly find out about FDA requirements for Medical Devices?

In the USA, medical devices are regulated within the FDA by the Center for Devices and Radiological Health (CDRH). How can one quickly familiarize oneself with the topic of "medical devices" or stay up to date? For this purpose, the FDA offers an own website: CDRH Learn.

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  • 31-07-2019
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

Cursos Eudravigilance no Infarmed em novembro de 2019

Vai decorrer, nas instalações do Infarmed, nos dias 18 a 20 de novembro de 2019, o curso "ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on Training Course using the EudraVigilance System", promovido pela Drug Information Association (DIA).

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  • 30-07-2019
EMA - European Medicines Agency

Substances considered as not falling within the scope of Regulation (EC) No. 470/20091, about residues of veterinary medicinal products in foodstuffs of animal origin

 

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  • 29-07-2019
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

Implementação dos regulamentos de DM e DIV - Atualização das orientações da Comissão Europeia

A Comissão Europeia disponibilizou novos documentos orientadores que visam esclarecer e facilitar a implementação dos Regulamentos Europeus dos Dispositivos Médicos (DM) e dos Dispositivos Médicos para Diagnóstico In Vitro (DIV).

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  • 26-07-2019
Diário da República

Resolução da Assembleia Legislativa da Região Autónoma da Madeira n.º 23/2019/M - Diário da República n.º 141/2019, Série I de 2019-07-25

Apresenta à Assembleia da República a proposta de lei que procede à primeira alteração ao Decreto-Lei n.º 124/2018, de 28 de dezembro, que clarifica as regras aplicáveis à comparticipação de medicamentos e dispositivos médicos pelo sistema de proteção social dos trabalhadores em funções públicas.

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  • 25-07-2019
ECA - European Compliance Academy

Safety Features - how is it progressing?

The MHRA will be issuing a series of blog posts regarding the implementation of the FMD over the next few months. The first post looks at the robustness of incoming checks.

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  • 24-07-2019
EDQM

10th Edition of Ph. Eur.: CEP holders are invited to update their applications

CEP holders are invited to update their applications according to the revised monographs that will be implemented on the 1st of January 2020 in the 10th Edition of the Ph. Eur., and to follow the instructions given in the document.

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  • 23-07-2019
EMA - European Medicines Agency

Essential maintenance to computer applications

Essential maintenance is scheduled to be carried out to SPOR data services: Referential Management Services (RMS) and Organisations Management Services (OMS) between between 19:00hrs (CEST) and 20:00hrs (CEST) on Tuesday, 23 July 2019. Applications consuming real-time RMS data (PSUR Repository, MMS-e, EudraGMDP, EudraCT, EU PAS (ENCepp), and eAF) will be affected intermittently during this time. Should you have any questions please contact the EMA IT Service Desk.

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  • 22-07-2019
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

Aviso de indisponibilidade do portal SIATS e das plataformas SMUH-AIM e SMUH-ALTER

Informa-se que, por motivos de manutenção, o portal SIATS e as plataformas SMUH-AIM e SMUH-ALTER estarão indisponíveis entre as 9h e as 12h do dia 22/07/2019.

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  • 19-07-2019
EDQM

Certification procedure: revised documents July 2019

The EDQM has revised the following documents to reflect current practice and clarify a couple of items: Terms of reference and Code of Practice for the Certification procedure.

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  • 18-07-2019
ECA - European Compliance Academy

Update of the borderline guideline on medical devices

At what point is a medical device to be considered a medical device in Europe? The classification of so-called borderline products is sometimes difficult. An updated EU guideline may be able to help. 

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  • 17-07-2019
ECA - European Compliance Academy

Do liquid, sterile medicinal products have to be particle-free?

According to the pharmacopoeias, parenteralia, i.e. sterile medicinal products for injection purposes, must be 100% visually inspected. In addition to damages to the primary container, the absence of particles has also to be checked. But do these medicinal products also have to be 100% free of particles? Read more here.

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  • 16-07-2019
EDQM

As of 1 January 2020 the eCTD is mandatory for ALL CEP applications including notifications, revision, renewal and new applications

According to the EDQM roadmap for electronic submissions for CEP applications, a major change will be implemented as of 1 January 2020: • eCTD will become mandatory for all CEP applications. • EDQM will stop accepting NeeS submissions for notifications, revisions and renewal applications. Therefore, all such submissions need to be in eCTD format.

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  • 15-07-2019
EMA - European Medicines Agency

EU and US reach a milestone in mutual recognition of inspections of medicines manufacturers

 

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  • 12-07-2019
ECA - European Compliance Academy

News from the clinical trial portal and database

The new CTR becomes applicable six months after the notice of the full functionality of the CTIS. The EMA informed that the CTIS now enters a phase of agile, iterative delivery, to prepare the system for audit.

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  • 11-07-2019
EMA - European Medicines Agency

Advice on impacts of using antimicrobials in animals

The European Medicines Agency (EMA) is involved in monitoring and evaluating the risks of using antibiotics in animals. It has looked in particular at the risk of the development of antimicrobial resistance in animals and of the possible transmission of resistance to humans.

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  • 10-07-2019
EDQM

Pharmeuropa Volume 31 No 3, July 2019

Users of CEPs are invited to provide comments on draft monographs published in Pharmeuropa 31.3 before 30 September 2019.

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  • 09-07-2019
ECA - European Compliance Academy

Creams, Gels & Pastes redefined

A revised version of the Ph. Eur. Monograph Semi-solid preparations for cutaneous application has been published in Pharmeuropa.

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  • 08-07-2019
EMA - European Medicines Agency

Medicine shortages: EU network takes steps to improve reporting and communication

 

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  • 05-07-2019
EMA - European Medicines Agency

Call for all sponsors to publish clinical trial results in EU database

 

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  • 04-07-2019
FDA - Food and Drug Administration

FDA warns repackers distributing pharmaceutical ingredients, including opioids, for putting consumers at risk

The U.S. Food and Drug Administration has issued warning letters to three repackers of active pharmaceutical ingredients (API), B&B Pharmaceuticals, Inc., Asclemed USA, Inc., doing business as Enovachem and Spectrum Laboratory Products, Inc., for significant violations of current good manufacturing practice (CGMP) requirements.

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  • 03-07-2019
ECA - European Compliance Academy

10th Edition of the Ph. Eur.

The 10th edition of the Ph. Eur. will be released in July 2019. The new and revised texts will become official on 1 January 2020.

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  • 02-07-2019
EMA - European Medicines Agency

Product-information templates

Compliance with QRD template v10.1

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  • 01-07-2019
EMA - European Medicines Agency

QRD product-information annotated template (English) version 10.1 - highlighted

 

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  • 28-06-2019
ECA - European Compliance Academy

Serialisation: New Guidance for EU Inspectors

The European Commission has published an Aide-Memoire to help both manufacturers and inspectors to verify compliance with the safety features regulation.

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  • 27-06-2019
EMA - European Medicines Agency

Temporary interim limits for NMBA, DIPNA and EIPNA impurities in sartan blood pressure medicines

 

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  • 26-06-2019
FDA - Food and Drug Administration

More Notified Bodies Give Up on EU MDR/IVD Certification

“Following recent market developments, we have made the strategic business decision to exit from [notified body certification] services,” said Lloyd’s Register Quality Assurance.

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  • 25-06-2019
ECHA

ECHA to scrutinise all REACH registrations by 2027

ECHA will start to evaluate 20 % of registration dossiers in each tonnage band to improve the compliance of REACH registrations. This will mean approximately 30 % of all registered chemicals will be checked. 

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  • 24-06-2019
UK Government

The Human Medicines (Amendment etc.) (EU Exit) (No. 2) and the Medical Devices (Amendment etc.) (EU Exit) (No. 2) Regulations 2019

These Regulations (which come into force immediately before exit day) are made to correct drafting defects and omissions in the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775) and the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791). This is to ensure that the published policy in relation to the regulation of human medicines and medical devices in a no deal EU exit scenario is properly reflected in those instruments. Those instruments, which come into force on exit day, amend the Human Medicines Regulations 2012 (S.I. 2012/1916 – “HMRs”), associated Medicines (Fees) Regulations 2016 and the Medical Devices Regulations 2002 (S.I. 2002/618 – “MDRs”) to ensure they are fit for purpose in a no deal EU exit.

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  • 21-06-2019
CMDh - Co-ordination group for Mutual recognition and Decentralised procedures - Human

NEW - CMDh Q&As on the implementation of the outcome of the Art. 31 referral on angiotensin-II-receptor antagonists (sartans) containing a tetrazole group

 

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  • 19-06-2019
EMA - European Medicines Agency

United Kingdom's withdrawal from the European Union ('Brexit')

On 29 March 2017, the United Kingdom (UK) notified the European Council of its intention to withdraw from the European Union (EU), a process known as 'Brexit'. The European Medicines Agency (EMA) is making preparations to ensure that it can continue to deliver on its mission and protect public and animal health after the UK leaves the EU.

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  • 18-06-2019
EMA - European Medicines Agency

Leuprorelin-containing depot medicinal products

Leuprorelin , See "List of the medicines affected by the referral (Annex I)", Article 31 referrals, Procedure started


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  • 17-06-2019
EDQM

Control of nitrosamine impurities in sartans: revision of five Ph. Eur. monographs

The European Commission has issued its final legally binding decision on medicines containing valsartan, candesartan, irbesartan, losartan and olmesartan on 2 April 2019. This decision was based on the scientific assessment of angiotensin-II-receptor antagonists (sartans) containing a tetrazole group performed by the Committee for Medicinal Products for Human Use (CHMP), the conclusions of which are set out in Annex I to the European Commission Decision C(2019) 2698 final.

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  • 14-06-2019
EMA - European Medicines Agency

Two additional countries to benefit from EU-US mutual recognition agreement for inspections

 

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  • 12-06-2019
Eur-Lex

Commission Implementing Decision (EU) 2019/939 of 6 June 2019 designating issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical devices

 

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  • 11-06-2019
EMA - European Medicines Agency

EMA closed 10 June 2019

EMA is closed from 18:30 on Friday 7 June until 7:30 on Tuesday 11 June 2019.

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  • 07-06-2019
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

Alegações em produtos cosméticos

Conforme referido na Circular Informativa n.º 106/CD/100.20.100/2018, de 27/07/2018, o Regulamento (CE) n.º 1223/2009, de 30 de novembro, relativo aos produtos cosméticos, estabelece que os consumidores devem ser protegidos contra alegações enganosas e garante que a informação transmitida através dessas alegações é útil, compreensível e fiável, permitindo aos consumidores tomar decisões informadas e escolher os produtos que melhor se adequem às suas necessidades e expectativas.

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  • 06-06-2019
ECA - European Compliance Academy

cGMP Cleaning Validation - FDA's Current Requirements

What do authorities require regarding cleaning validation? Official GMP inspection reports deliver helpful answers to this question. Through the Freedom of Information Act, the FDA is required to publish inspection results. This is particularly the case with Warning Letters. Here, even details of deficiencies regarding cleaning validation are included in the Warning Letter. 

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  • 05-06-2019
EMA - European Medicines Agency

Consultation on draft guideline on quality requirements for medical devices in combination products

  

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  • 04-06-2019
ICH

ICH E19 public consultation

A new ICH-E19 draft guideline on the optimisation of safety data collection in interventional clinical trials and non-interventional studies has been published by ICH for public consultation. The guideline objective is to provide internationally harmonised guidance on when it would be appropriate to use a selective approach to safety data collection in some late-stage pre-marketing or post-marketing studies, and how such approach would be implemented. Comments should be submitted by 29 September 2019 to the following email address: ich@ema.europa.eu.

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  • 03-06-2019
Ordem dos Farmacêuticos

OMS quer mais transparência no preço dos medicamentos

Os Estados-membros da Organização Mundial da Saúde (OMS) aprovaram uma resolução que desafia os países a partilharem informações sobre os preços negociados com a indústria farmacêutica, sugerindo também uma maior transparência em torno das patentes de medicamentos e resultados de ensaios clínicos. O documento foi aprovado durante a 72.ª Assembleia Mundial da Saúde, realizada em Genebra, entre 20 e 28 de maio.

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  • 31-05-2019
EMA - European Medicines Agency

Withdrawal of marketing authorisations for fenspiride medicines

 

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  • 30-05-2019
ECA - European Compliance Academy

Revised USP chapter <3> Topical and Transdermal Product Quality Tests

The revised USP general chapter <3> TOPICAL AND TRANSDERMAL DRUG PRODUCTS - PRODUCT QUALITY TESTS has been approved.

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  • 29-05-2019
EMA - European Medicines Agency

EMA closed 30-31 May 2019

 

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  • 28-05-2019
FDA - Food and Drug Administration

Lawmakers Claim Purdue Influenced WHO Opioid Guidelines

A bi-partisan congressional report claims that Purdue Pharma helped shape World Health Organization recommendations for prescribing opioids.

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  • 27-05-2019
Ordem dos Farmacêuticos

ERS esclarece tratamento de dados em saúde

A Entidade Reguladora da Saúde (ERS) emitiu um parecer sobre o tratamento de dados em saúde, tendo por base o novo Regulamento Geral de Proteção de Dados (RGPD), que exige aos prestadores de cuidados de saúde, independentemente da sua natureza jurídica ou dimensão, uma adequação exigente e cuidada dos seus processos de tratamento de dados pessoais, sempre visando a garantia dos direitos e liberdades dos titulares desses dados.

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  • 24-05-2019
ECA - European Compliance Academy

New WHO Draft for GDP Guidance

The World Health Organisation WHO plans to revise its Good Storage and Distribution Practice guidelines and to consolidate the rules in one single document.

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  • 23-05-2019
DGAV - Direção-Geral de Alimentação e Veterinária

Pau de Cabinda - Esclarecimento adicional

A DGAV disponibiliza esclarecimento adicional sobre a “Proibição do uso de Pau de Cabinda a partir de 14 Maio 2019”.

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  • 22-05-2019
ECA - European Compliance Academy

Recent GMP defects in process validation

What are the authorities' requirements regarding process validation? Regulatory GMP inspection reports are useful in answering that question. The "Freedom of Information Act" obliges the US FDA to publish all inspection results. The FDA does that particularly when it comes to warning letters.

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  • 21-05-2019
EMA - European Medicines Agency

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 May 2019

 

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  • 20-05-2019
FDA - Food and Drug Administration

FDA Lays Out Weight of Evidence Guidelines for Fetal Toxicity in Oncology

The weight of evidence could include a review of existing literature.

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  • 17-05-2019
ECA - European Compliance Academy

New office-based GDP-Inspection Process in UK

The U.K. Medicines and Health Products Agency (MHRA) is testing a new, office-based inspection process - without a visit of the site. 


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  • 16-05-2019
ECA - European Compliance Academy

How does the GDPR impact Clinical Trials?

The European Commission released a Question and Answers paper on the interplay between the Clinical Trials Regulation (CTR) and the General Data Protection Regulation (GDPR).

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  • 15-05-2019
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

Implementação das obrigações legais no que respeita aos dispositivos de segurança

 

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  • 14-05-2019
EMA - European Medicines Agency

Medical devices

In early June 2019 EMA will publish a draft guideline on quality requirements for regulatory submissions for medicines that include a medical device (drug-device combinations). The guidance will cover devices which are integral, co-packaged or supplied separately. The public consultation is expected to last three months.

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  • 13-05-2019
ICH

The ICH E8(R1) reaches Step 2b of the ICH Process

The ICH E8(R1) draft Guideline on General Considérations for Clinical Trials reached Step 2b of the ICH Process in May 2019 and has entered the public consultation period.

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  • 10-05-2019
FDA - Food and Drug Administration

Statement from Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., and Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research

It can be a challenge for health care professionals and patients to find quality scientific information about the safety of drugs and biological products when used during pregnancy or breastfeeding. Ethical challenges often arise in studying women in these populations as there are valid concerns about maternal and fetal safety.

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  • 09-05-2019
European Comission

Hearing on the SCHEER preliminary Guidelines on the presence of Phthalates in certain medical devices (Brussels, 04 April 2019) - Summary records and presentations now available

 

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  • 08-05-2019
EMA - European Medicines Agency

European Medicines Agency closed 9 May 2019

 

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  • 07-05-2019
FDA - Food and Drug Administration

MedTech Europe Says EU MDR/IVDR Transition is Not Workable

MedTech Europe is warning European regulators that the EU’s new regulatory system for devices won’t be ready on time and said the delay will jeopardize patient lives.

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  • 06-05-2019
Eur-Lex

Corrigendum to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices

 

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  • 03-05-2019
EMA - European Medicines Agency

Two additional countries to benefit from EU-US mutual recognition agreement for inspections

 

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  • 02-05-2019
ECA - European Compliance Academy

Batch Records: who needs to review?

The Qualified Person (QP) often reviews the batch documentation personally prior to certification of a batch. But is the QP obliged to the review of the batch documentation?

read more >

  • 30-04-2019
EMA - European Medicines Agency

European Medicines Agency closed 1 May 2019

 

read more >

  • 29-04-2019
FDA - Food and Drug Administration

European Parliament Evens Scales for Generics Makers With New SPC Waivers

The European Commission says the reform will “remove a major competitive disadvantage.”

read more >

  • 26-04-2019
FDA - Food and Drug Administration

Statement from FDA Associate Commissioner for Regulatory Affairs Melinda K. Plaisier, on agency’s new steps to strengthen the process of initiating voluntary recalls

Voluntary recalls are one of the most important safety tools overseen by the U.S. Food and Drug Administration. They are a vital means to protect public health and typically are the quickest way to remove defective or potentially harmful food, medical, and consumer products from the market. The FDA plays an important role in the recall process, closely overseeing FDA-regulated companies during their voluntary recalls to help ensure public health is protected.

read more >

  • 24-04-2019
ECA - European Compliance Academy

EMA's Annual Report on the EudraVigilance Database

The EMA has published the Annual Report 2018 on EudraVigilance summarizing the current status of the database.

read more >

  • 23-04-2019
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

Indisponibilidade

Por motivos de ordem técnica, o site do Infarmed estará indisponível durante o dia 23 de abril (amanhã, 3ª feira). read more >

  • 22-04-2019
EDQM

Ph. Eur. endorses semi-quantitative HPTLC testing for traditional Chinese medicines

The European Pharmacopoeia (Ph. Eur.) Commission has decided to accept semi-quantitative High-Performance Thin-Layer Chromatography (HPTLC) tests as an alternative quality control which could be used instead of liquid chromatography (LC) assays in monographs on Traditional Chinese Medicines (TCM).

read more >

  • 18-04-2019
ECA - European Compliance Academy

GMP for Sterile Containers

Following the Q&As on what data is required for sterilization processes of primary packaging materials published in 2016, the EMA recently released the new Guideline on the sterilization of the medicinal product, active substance, excipient and primary container.

read more >

  • 17-04-2019
EMA - European Medicines Agency

EMA closed 18-22 April 2019

 

read more >

  • 16-04-2019
EMA - European Medicines Agency

Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure

 

read more >

  • 15-04-2019
EMA - European Medicines Agency

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 April 2019

 

read more >

  • 12-04-2019
EDQM

Pharmeuropa Volume 31 No 2, April 2019

Users of CEPs are invited to provide comments on draft monographs published in Pharmeuropa 31.2 before 30 June 2019.

read more >

  • 11-04-2019
DGAV - Direção-Geral de Alimentação e Veterinária

Manual de Rotulagem de Produtos Fitofarmacêuticos

A DGAV divulga o Manual de Rotulagem de Produtos Fitofarmacêuticos, produzido com vista a auxiliar os requerentes de autorizações de venda de produtos fitofarmacêuticos, na rotulagem dos seus produtos em conformidade com a legislação nacional e comunitária em vigor aplicável à classificação, embalagem e rotulagem de produtos fitofarmacêuticos.

read more >

  • 10-04-2019
ECA - European Compliance Academy

EMA Guide on Sterilisation for Medicinal Products, API Excipients and Primary Packaging published

At the beginning of March, the EMA published a guideline for the sterilization of drugs, active ingredients, excipients and also primary packaging.

read more >

  • 09-04-2019
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

Portal Inspeção+

No âmbito do programa SIMPLEX+, estará disponível a partir do dia 8 de abril de 2019, o portal Inspeção+, que tem como objetivo simplificar a interação com as entidades do circuito do medicamento e dos produtos de saúde alvo de ações inspetivas, através da desmaterialização do processo de inspeção e respetivas respostas, bem como agregar toda a informação deste âmbito.

read more >

  • 08-04-2019
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

Procedimento sobre Gestão da Indisponibilidade do Medicamento

No sentido de contribuir para uma gestão da indisponibilidade do medicamento mais eficiente e equilibrada, de modo a prevenir a sua ocorrência ou mitigar o impacto que possa causar no cidadão, o Infarmed publica o procedimento sobre Gestão da Indisponibilidade do Medicamento.

read more >

  • 05-04-2019
EDQM

First OMCL Network test method for the determination of NMBA in losartan K drug substance published (03/04/19)

Since the start of the sartan crisis in summer 2018, OMCLs of the European Network have elaborated a number of test methods to qualify and quantify nitrosamines in Active Pharmaceutical Ingredients (APIs) and drug products of the sartan group. While at the beginning, work focused on the two major reported contaminants, N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA), laboratories of the Network are now extending their test methods to other potential nitrosamines.

read more >

  • 04-04-2019
ECA - European Compliance Academy

ICH M10 - Draft Guideline on Validation of Bioanalytical Methods published for public Comments

On 13 March, the European Medicines Agency (EMA) published a the draft ICH Guideline M10 on bioanalytical method validation for public comments. 

read more >

  • 03-04-2019
EMA - European Medicines Agency

Regulatory information – 1.7% increase of fees from 1 April 2019

 

read more >

  • 02-04-2019
EMA - European Medicines Agency

Draft ICH guideline E19 on optimisation of safety data collection - Step 2b

 

read more >

  • 01-04-2019
EMA - European Medicines Agency

20 years of sampling and testing of centrally authorised products: 1998 – 2017

 

read more >

  • 29-03-2019
EMA - European Medicines Agency

New EudraVigilance system improves reporting of side effects and detection of safety signals

 

read more >

  • 28-03-2019
EMA - European Medicines Agency

Questions & answers: EU actions to prevent medicine shortages due to Brexit

 

read more >

  • 27-03-2019
FDA - Food and Drug Administration

PRAC Takes a Closer Look at Anti-Cancer/Skin Drug

The advisory committee is worried that the drugs may be building up in the bodies of patients who lack a key enzyme.

read more >

  • 26-03-2019
EMA - European Medicines Agency

EMA Management Board: highlights of March 2019 meeting

 

read more >

  • 25-03-2019
UK Government

MHRA guidance and publications on a possible no deal scenario

Information about the regulation of medicines and medical devices if the UK leaves the EU with no deal.

read more >

  • 22-03-2019
ICH

Publication of the ICH M10 draft Guideline and Presentation

The ICH M10 draft Guideline on Bioanalytical Method Validation reached Step 2b of the ICH Process on the 26 February 2019 and now enters the consultation period.

read more >

  • 21-03-2019
ECA - European Compliance Academy

GMP for Cannabis - What is required?

More and more countries allow cannabis for medicinal purposes - But what are the regulatory requirements?

read more >

  • 20-03-2019
ECA - European Compliance Academy

Delivery of not ordered goods - what to do?

A wholesaler receives a delivery of a medicinal product. However, the order was not placed. What should be done?

read more >

  • 19-03-2019
DGAV - Direção-Geral de Alimentação e Veterinária

Medicamentos veterinários: Atualização Brexit

Pedidos de isenção por tempo limitado para continuar o teste de controlo de lote no Reino Unido após a saída do Reino Unido da União Europeia.

read more >

  • 18-03-2019
EMA - European Medicines Agency

ICH M10 on bioanalytical method validation

 

read more >

  • 15-03-2019
FDA - Food and Drug Administration

FDA Scraps Suffixes for Older Biologics’ Proper Names

The agency said it’s unnecessary to change the proper names of biological products that have already received licensing or approval and that lack an FDA-designated suffix. 

read more >

  • 14-03-2019
ECA - European Compliance Academy

EU Commission: How to prepare for a "Hard Brexit"

The European Commission is fostering its support in preparing EU companies for a no deal scenario ("Hard Brexit").

read more >

  • 13-03-2019
EMA - European Medicines Agency

EMA now operating from Amsterdam

 

read more >

  • 12-03-2019
EMA - European Medicines Agency

Sterilisation of the medicinal product, active substance, excipient and primary container

 

read more >

  • 11-03-2019
UK Government

MHRA guidance and publications on a possible no deal scenario

Information about the regulation of medicines and medical devices if the UK leaves the EU with no deal.

read more >

  • 08-03-2019
UK Government

Webinars related to making submissions to the MHRA if the UK leaves the EU with no deal

Links to recorded webinars which cover how stakeholders can make informed IT plans and preparations in the event of leaving the EU with no deal.

read more >

  • 07-03-2019
ECA - European Compliance Academy

Brexit: Handling Pharmacovigilance Data from the UK

How should reports of adverse reactions from the UK be handled after the withdrawal date? New Q&As give a clear answer.

read more >

  • 06-03-2019
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

Atualização da Informação de Medicamentos (alterações C.I.z. IAIN)

O Infarmed solicitou à EMA as seguintes alterações ao template Quality Review of Documents (QRD):

 - Folheto Informativo - Alteração dos termos "efeitos secundários" para "efeitos indesejáveis";

 - RCM e FI - Atualização dos contactos para notificação de suspeitas de reações adversas /efeitos indesejáveis, com a finalidade de privilegiar a utilização do Portal RAM.

read more >

  • 04-03-2019
EMA - European Medicines Agency

First guidance on new rules for certain medical devices

EMA has published the first of a series of guidance documents to help applicants prepare for obligations stemming from the new EU regulations on medical devices.

read more >

  • 01-03-2019
UK Government

How to make submissions to the MHRA if the UK leaves the EU with no deal

Updated information for stakeholders so they can make informed IT plans and preparations in the event of leaving the EU with no deal.

read more >

  • 28-02-2019
EMA - European Medicines Agency

Procedural update on submission of Type I variations to EMA in March, April and May 2019

EMA is encouraging marketing authorisation holders (MAHs) intending to submit Brexit-related Type IA and Type IB variations in March 2019 to file these variations as early as possible during the month. This will enable EMA to process the submissions before 29 March so that MAHs can receive confirmation of compliance with the regulatory and legal requirements before this date.

read more >

  • 27-02-2019
European Comission

Information – Withdrawal of the United Kingdom and EU rules on batch testing of medicinal products

 

read more >

  • 26-02-2019
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

Nova área sobre o BREXIT

Foi criada uma nova área dedicada ao BREXIT, disponibilizando informação relevante no âmbito deste processo e que pode consultar a partir do menu principal na primeira página do site do Infarmed.


read more >

  • 25-02-2019
EMA - European Medicines Agency

EU and Switzerland to improve information-sharing on good manufacturing practice through use of the EudraGMDP database

The Swiss Agency for Therapeutic Products (Swissmedic) has started in 2019 to enter information on Good manufacturing practice (GMP) compliance as well as on manufacturing authorisations related to Swiss manufacturers into the European Union’s EudraGMDP database. 

read more >

  • 22-02-2019
ECA - European Compliance Academy

Brexit: Safety Features & Multi-Country Packs

Will it be necessary to transfer information about the unique identifier uploaded to the UK repository between 9 February 2019 and the Brexit date to another repository? EMA recently published  the answer to this and other related questions.

read more >

  • 20-02-2019
EDQM

The chapter on water: micro determination (2.5.32.) has been revised in the Ph. Eur. Supplement 9.8.

The instrument qualification is carried out according to established quality system procedures, for example using a suitable certified reference material. Sodium aminosalicylate dihydrate for equipment qualification CRS may be used when proceeding by direct or liquid sample introduction, whereas amoxicillin trihydrate for performance verification CRS may be used with the evaporation technique.

read more >

  • 19-02-2019
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

Indisponibilidade dos sistemas de informação

Informa-se que, por motivos de manutenção da infraestrutura, todos os sistemas de informação do Infarmed assim como os e-mails do seu domínio ficarão indisponíveis entre as 18h do dia 15/02/2019 e as 24h do dia 17/02/2019.

read more >

  • 15-02-2019
FDA - Food and Drug Administration

FDA Proposes Voluntary Consensus Standards to Help Speed Drug Reviews

CDER released draft guidance on a proposal to create voluntary consensus standards for drug quality that would help boost innovation and speed up drug reviews.

read more >

  • 14-02-2019
ECA - European Compliance Academy

Safety Features: Handling of Alerts

The safety feature provisions enetered into force - How to report a falsified pack?

read more >

  • 13-02-2019
EDQM

Elemental impurities reference standards: leaflets now include expanded uncertainty

The EDQM has updated the leaflets of its reference standards for elemental impurities (lead solution CRS, cadmium solution CRS, mercury solution CRS and arsenic solution CRS) with further information to facilitate their use and make traceability transparent. The mass fractions of the assigned element are traceable to the SI units (mole and kilogram) through an uninterrupted chain, similar to certified reference materials established by a national metrological institute.

read more >

  • 12-02-2019
European Comission

Falsified medicines: new rules to enhance patients' safety

 

read more >

  • 11-02-2019
FDA - Food and Drug Administration

FDA Issues Manual on Developing a Shared System REMS

The FDA released a new manual of policies and procedures (MAPP) for developing a shared system risk evaluation and mitigation strategy (REMS).

read more >

  • 08-02-2019
ICH

Reflection Paper on Further Opportunities for Harmonization of Standards for Generic Drugs available now on the ICH website

The ICH Reflection Paper on Further Opportunities for Harmonization of Standards for Generic Drugs was endorsed by the ICH Assembly in November 2018.

read more >

  • 07-02-2019
ECA - European Compliance Academy

Current Questions and Answers on Data Integrity and Audit Trail Review

The topic data integrity generates a multitude of questions. Current questions are answered in a loose sequence of News. Question 1: Must there be a concept for evaluating the criticality of data? And what rules for entering critical data into computerised systems must be available? The answers to both questions can be found here.

read more >

  • 06-02-2019
EDQM

Update on the EDQM review of CEP applications for sartan substances (4 February 2019)

Following new information received recently about the presence of nitrosamine impurities in a drug substance covered by a certificate of suitability (CEP), the EDQM has taken immediate action and suspended.

read more >

  • 05-02-2019
European Comission

Document updated - Questions and Answers related to the United Kingdom's withdrawal from the European Union with regard to Medicinal products for human and veterinary use

 

read more >

  • 04-02-2019
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

Nova área sobre canábis para fins medicinais

No seguimento da publicação da Lei n.º 33/2018, de 18 de julho, que estabeleceu o quadro legal para a utilização de medicamentos, preparações e substâncias à base da planta da canábis para fins medicinais - nomeadamente a sua prescrição e a sua dispensa em farmácia, tendo o Decreto-Lei n.º 8/2019, de 15 de janeiro, procedido à sua regulamentação - esta nova área, com informação selecionada por público (cidadãos, profissionais de saúde e entidades), pretende esclarecer as diretivas emanadas deste novo quadro legal e contribuir para orientar no que respeita à sua aplicação prática.

read more >

  • 01-02-2019
ECA - European Compliance Academy

EMA starts moving to Amsterdam

The European Medicines Agency (EMA) has started with the relocation to the Netherlands and informs about contact details and continuation of the main activities.

read more >

  • 30-01-2019
UK Government

UK and Russia sign MoU on Regulatory Cooperation on Medicines

Medicines regulators of the UK and Russian set out key principles to support their collaboration on improving public health.

read more >

  • 29-01-2019
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

Diretrizes para a implementação dos dispositivos de segurança (após 9 de fevereiro de 2019)

O regime dos dispositivos de segurança surgiu com a diretiva 2011/62/UE do Parlamento Europeu e do Conselho, de 8 de junho de 2011, que veio introduzir alterações à Diretiva 2001/83/CE que estabelece um código comunitário relativo aos medicamentos para uso humano (art. 54.º A da referida legislação).

read more >

  • 28-01-2019
EDQM

Ph.Eur. Supplement 9.8 available now

The 9.8 supplement of European Pharmacopoeia is now available and will be applicable in 38 European countries as from 01 July 2019.

read more >

  • 25-01-2019
UK Government

How to make regulatory medicines submissions to the MHRA if the UK leaves the EU with no deal

Updated information for stakeholders so they can make informed IT plans and preparations in the event of leaving the EU with no deal.

read more >

  • 24-01-2019
ECA - European Compliance Academy

New WHO Guideline on Testing of Counterfeit Medicines

The World Health Organization (WHO) has published a new guideline describing the procedure for testing supposedly counterfeit or suspect medicines.

read more >

  • 23-01-2019
UK Government

Conversion of Community Marketing Authorisations to UK Marketing Authorisations – letter to industry

A second letter on conversion of Community Marketing Authorisations providing Product Licence numbers was sent on 2 January 2019 to Marketing Authorisation holders.

read more >

  • 22-01-2019
EDQM

Update on the review of CEP applications for sartans (18 January 2019)

Nitrosamine impurities can be formed due to the synthetic process used to manufacture valsartan and other ARB medicines or they may be introduced into the active substance when recovered materials which are contaminated with these impurities are used in a manufacturing process. Holders of CEPs are therefore requested to immediately inform EDQM of any contamination found in valsartan and or other ARBs manufactured and supplied using a CEP.

read more >

  • 21-01-2019
EFSA - European Food Safety Authority

EFSA to share data on open-access platform

EFSA has taken a major step towards becoming a fully open data organisation by committing to publish the scientific data it uses for EU-wide monitoring programmes and surveys and many of its risk assessments.

read more >

  • 18-01-2019
Diário da República

Decreto-Lei n.º 8/2019 - Diário da República n.º 10/2019, Série I de 2019-01-15117821810

Regulamenta a utilização de medicamentos, preparações e substâncias à base da planta da canábis para fins medicinais

read more >

  • 17-01-2019
EDQM

Revised guidance for elaborating monographs on radiopharmaceutical preparations: new section on validation of methods

Monographs and general texts on radiopharmaceutical preparations are elaborated by experts in the field. In order to guide experts on the information to be included in European Pharmacopoeia (Ph. Eur.) monographs, and also to harmonise the style of the different monographs, a Guide for the elaboration of monographs on radiopharmaceuticals was published by the EDQM in 2010. This Guide has now been updated to include a section on the validation of methods used in the analysis of radiopharmaceuticals, reflecting the validation requirements applicable to analytical methods included in Ph. Eur. monographs. The new validation section in the revised Guide is the result of a joint effort by Ph. Eur. experts on radiopharmaceuticals and the members of the European Association of Nuclear Medicine’s (EANM) Radiopharmacy Committee.

read more >

  • 15-01-2019
FDA - Food and Drug Administration

TGA Updates GMP Clearance Guidance for Overseas Facilities

The guidance also clarifies when applications will be dropped from the system due to nonpayment and includes a section on troubleshooting and staying up to date with guidance updates.

read more >

  • 11-01-2019
ECA - European Compliance Academy

Things to Consider for Medical Device Manufacturers when Relocating

In December 2018, the FDA published its finalised guideline entitled "Manufacturing Site Change Supplements: Content and Submission". The first draft dates back to October 2015. Now, who can use this document?

read more >

  • 10-01-2019
FDA - Food and Drug Administration

FDA Releases Data Integrity Guidance in Q&A Format

The FDA issued final guidance on data integrity and compliance with current good manufacturing practices. Commissioner Scott Gottlieb said the agency revised its recommendations in response to stakeholder requests for more details.

read more >

  • 09-01-2019
ECA - European Compliance Academy

Will EMA Plans change the Landscape of GMP?

EMA has published a strategic reflection paper "EMA Regulatory Science to 2025". As a consequence, the regulatory landscape, including GMP requirements and standards, needs to be adapted.

read more >

  • 08-01-2019
Eur-Lex

Regulation (EU) 2019/5 of the European Parliament and of the Council of 11 December 2018

Amending Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, Regulation (EC) No 1901/2006 on medicinal products for paediatric use and Directive 2001/83/EC on the Community code relating to medicinal products for human use.

read more >

  • 07-01-2019
UK Government

Further guidance note on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal

Updated information for stakeholders so they can make informed plans and preparations in the event of leaving the EU with no deal.

read more >

  • 04-01-2019
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

Indisponibilidade de sistemas de informação - dia 07/01/2019

Por motivos de manutenção, os seguintes sistemas de informação estarão indisponíveis durante todo o dia 07/01/2019: RNEC, SIOMS, SMUH AIM e ALTER, AUEs, Portal CAUL, Portal RAM, LIC, SIEXPORT, DMFAB e SDIV.

read more >

  • 03-01-2019
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

Restrição do mercado - Produtos destinados à prevenção ou tratamento da cistite contendo proantocianidinas

A Decisão de Execução (EU) 2017/1445 da Comissão Europeia de 08 de agosto de 2017 relativa ao grupo de produtos cujo principal efeito pretendido, dependente das proantocianidinas (PAC) presentes nos mirtilos-vermelhos-americanos (Vaccinium macrocarpon), é a prevenção ou o tratamento da cistite, veio estabelecer que o grupo de produtos acima referido (vulgarmente conhecidos como ¿produtos à base de arandos vermelhos¿ para prevenção ou tratamento da cistite) não está abrangido pela definição de dispositivo médico estabelecida na Diretiva 93/42/CEE do Conselho, de 14 de junho de 1993, relativa aos dispositivos médicos, pelo que estes produtos não devem ser comercializados como dispositivos médicos ostentando a marcação CE.

read more >

  • 02-01-2019
EDQM

Update on the review of CEP applications for sartans

Following new information received recently about the presence of nitrosamine impurities in drug substances covered by certificates of suitability (CEPs), the EDQM has taken immediate actions on CEPs until appropriate corrective actions are implemented by the relevant companies.

read more >

  • 21-12-2018
ECA - European Compliance Academy

New Ph. Eur Monograph on PAT adopted

The European Pharmacopoeia (Ph. Eur.) Commission adopted 16 new texts including the general chapter on PAT - Process analytical technology (5.25).

read more >

  • 20-12-2018
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

Carregamento de dados no sistema nacional de verificação de medicamentos - MVO Portugal

O INFARMED, I.P., no âmbito dos seus poderes de fiscalização do sistema nacional de verificação de medicamentos, em colaboração com a MVO Portugal, entidade responsável pela criação e gestão desse sistema, efetuou uma avaliação da informação relativa aos Identificadores Únicos (IUs) dos MSRM e MNSRM comparticipados já carregada no mesmo.

read more >

  • 19-12-2018
FDA - Food and Drug Administration

FDA Revises Guidance on CGMPs for Outsourcing Facilities

The agency said it continues to find “concerning conditions and practices” in outsourcing facilities.

read more >

  • 18-12-2018
Diário da República

Portaria n.º 326-A/2018

A presente portaria altera e republica a Portaria n.º 314-A/2018, de 7 de dezembro, que procedeu à definição dos países de referência a considerar em 2019, para a autorização dos preços dos novos medicamentos e para efeitos de revisão anual de preços dos medicamentos do mercado hospitalar e do mercado de ambulatório, mantendo, para o mesmo ano, o critério excecional a aplicar no regime de revisão de preços.

read more >

  • 17-12-2018
FDA - Food and Drug Administration

EMA Invites Comments on Water Quality Guideline for Drugmakers

The EMA is seeking stakeholder feedback on a draft guideline on the quality of water for pharmaceutical use.

read more >

  • 14-12-2018
ECA - European Compliance Academy

New Ph. Eur. Structure of Chapter 3 on Materials and Containers

The Ph. Eur. Commission decided to restructure Ph. Eur. Section 3 on materials and containers. A new Subsection 3.3. has been added to cover items that are classified as medical devices according to EU legislation. Read more about 3.3. Containers for human blood and blood components, and materials used in their manufacture; transfusion sets and materials used in their manufacture; syringes.

read more >

  • 13-12-2018
ECA - European Compliance Academy

Revision of EMA's Guideline on the Use of Pharmaceutical Water

In the course of the revision of the European Pharmacopoeia which allows the production of WFI with other methods than distillation, the revision of EMA's "Guideline on the quality of water for pharmaceutical use" has become necessary.

read more >

  • 12-12-2018
FDA - Food and Drug Administration

EMA Proposes Decision Tree Approach to Environmental Risk Assessments

The guidance also includes a diagram with steps applicants should take for conducting Phase I and Phase II assessments.

read more >

  • 11-12-2018
EMA - European Medicines Agency

Mobile scanning and other technologies in the labelling and package leaflet of centrally authorised medicinal products

 

read more >

  • 10-12-2018
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

Revisão anual de preços para 2019

Já se encontram disponíveis, na área "Revisão de preços", todos os documentos de apoio à revisão anual de preços de medicamentos não genéricos (mercado ambulatório e mercado hospitalar) para 2019.

read more >

  • 07-12-2018
FDA - Food and Drug Administration

FDA Issues 63 New Product-Specific Guidances for Generic Drugmakers

The FDA is “making the process for copying these medicines more efficient and creating an easier path for generic alternatives to enter the market,” said Commissioner Scott Gottlieb.

read more >

  • 06-12-2018
EMA - European Medicines Agency

Launch of the new EudraVigilance system: questions and answers from stakeholders

Update

read more >

  • 05-12-2018
ECA - European Compliance Academy

New ICH Topic Q14 and Revision of Q2

A new ICH topic was endorsed by the ICH Management Committee in November 2018. Read more about the proposed new ICH Q14 guideline Analytical Procedure Development and the revision of Q2(R1) Analytical Validation.

read more >

  • 04-12-2018
EMA - European Medicines Agency

Guidance on the format of the risk management plan (RMP) in the EU - in integrated format (Rev. 2.0.1)

 

read more >

  • 03-12-2018
ECA - European Compliance Academy

MRA: FDA accepts four new States

The US Food and Drug Administration (FDA) announced that it accepted four new states, which will now benefit from the EU-US Mutual Recognition Agreement MRA.

read more >

  • 29-11-2018
ECA - European Compliance Academy

Classification of GMP Deficiencies - A new Guideline of the PIC/S

Following the committee meeting at the end of September 2018, the PIC/S working group had elaborated a new guideline on the classification of GMP deficiencies which is going to be adopted.

read more >

  • 28-11-2018
European Comission

Questions and answers (version 12) - Safety features for medicinal products for human use

 

read more >

  • 27-11-2018
EMA - European Medicines Agency

Qualification of non-genotoxic impurities

 

read more >

  • 26-11-2018
EMA - European Medicines Agency

Non-clinical requirements for radiopharmaceuticals

 

read more >

  • 23-11-2018
ECA - European Compliance Academy

Brexit: EMA to focus on Medicines Evaluation and Supervision

End of September the EMA together with the European Commission organised a meeting with industry stakeholders to discuss the UK's withdrawal from the European Union ("Brexit"). Now the report of the EMA-Industry stakeholder meeting was published.

read more >

  • 22-11-2018
EDQM

Revised Guideline on requirements for revision/renewal of CEPs: corrected version available

N.B. A corrected version of the guidelines is available where under change 4.II.1.1 c) & e) specific documentation 2 has been deleted and under 4.II.1.2. condition 4 has been deleted since superfluous.

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  • 21-11-2018
EMA - European Medicines Agency

Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’

 

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  • 20-11-2018
EMA - European Medicines Agency

Disabling and potentially permanent side effects lead to suspension or restrictions of quinolone and fluoroquinolone antibiotics

 

read more >

  • 19-11-2018
ECA - European Compliance Academy

Stability by Design - Guidelines for Assessing & Controlling Physical Stability

The USP Physical Stability Joint Subcommittee has published a Stimuli article regarding Guidelines For Assessing and Controlling the Physical Stability of Pharmaceutical Raw Materials, Intermediates, and Dosage Forms.

read more >

  • 16-11-2018
UK Government

Drug Safety Update: monthly PDF newsletter

Monthly PDF editions of the Drug Safety Update newsletter from MHRA and its independent advisor the Commission on Human Medicines

read more >

  • 15-11-2018
ECA - European Compliance Academy

Valsartan: New Inspection reveals significant GMP Violations

An inspection by EU inspectorates in collaboration with EDQM has revealed significant GMP violations at a Valsartan manufacturer's site.

read more >

  • 14-11-2018
AEMPS - Agencia Española de Medicamentos y Productos Sanitarios

Circular nº 1/2018: Instrucción sobre excipientes

Actualización de la información sobre excipientes en la información de medicamentos.

read more >

  • 13-11-2018
European Comission

EU Health Policy Platform Holds Third Annual Meeting

  read more >

  • 12-11-2018
FDA - Food and Drug Administration

FDA Guidance Revises Packaging Terms for Injectable Medical Products

The FDA issued final guidance on “single-dose” and “multiple-dose” containers for injectable medical products — introducing a new term “single-patient use.”

read more >

  • 09-11-2018
ECA - European Compliance Academy

Stability by Design - Guidelines for Assessing & Controlling Physical Stability

The USP Physical Stability Joint Subcommittee has published a Stimuli article regarding Guidelines For Assessing and Controlling the Physical Stability of Pharmaceutical Raw Materials, Intermediates, and Dosage Forms in Pharmacopeial Forum (PF).

read more >

  • 08-11-2018
EDQM

The Ph. Eur. has launched a public consultation on two major texts for the testing of parenteral drugs

The European Pharmacopoeia (Ph. Eur.) Commission is consulting its stakeholders on Ph. Eur. dosage form monograph on Parenteral preparations (0520) and new informative chapter on testing for visible particles (5.17.2).

read more >

  • 07-11-2018
AEMPS - Agencia Española de Medicamentos y Productos Sanitarios

Publicación de Informes de Posicionamiento Terapéutico

 

read more >

  • 06-11-2018
FDA - Food and Drug Administration

FDA Releases FY 2018 Numbers for Fast-Tracked ANDA Generics

The FDA logged a steadily increasing number of fast-tracked ANDAs in fiscal year 2018, according to the agency’s first annual report mandated by the FDA Reauthorization Act.

read more >

  • 05-11-2018
EMA - European Medicines Agency

Working with stakeholders to improve availability of medicines in the EU

The task force set up by EMA and the Heads of Medicines Agencies (HMA) on availability of authorised human and veterinary medicines is organising a two-day workshop (8-9 November 2018) at EMA in London to gather stakeholders' perspectives on how to better address potential problems with the supply of medicines and how to avoid shortages of medicines.

read more >

  • 02-11-2018
EDQM

Ph. Eur. seeks feedback on general chapter covering depyrogenation in parenteral preparations

The European Pharmacopoeia (Ph. Eur.) has launched a public consultation on its new general chapter 5.1.12 on depyrogenation of items used in the production of parenteral preparations. While depyrogenation is not a new topic for the Ph. Eur., this is the first time that a dedicated chapter covers specifically the inactivation of pyrogens and related endotoxin indicators. Pyrogens are substances that can induce fever when infused or injected and must be removed from materials that come into direct contact with final sterilised products, such as primary packaging and equipment.

read more >

  • 31-10-2018
CMDh - Co-ordination group for Mutual recognition and Decentralised procedures - Human

National information on MAH transfers

Update

read more >

  • 30-10-2018
AEMPS - Agencia Española de Medicamentos y Productos Sanitarios

News in the treatment of registration records of dossiers of medicines for human use

Updates regarding the submission of applications for regulatory activities of medicines for human use, with the mandatory use of the eCTD format as of January 1, 2019 in all applications for authorization, variation and revalidation, both under national (NP) and European ( MRP / CP / DCP), establishing a series of exceptions, in purely national procedures, included in Raefar II and indicated in this informative note.

read more >

  • 29-10-2018
CMDh - Co-ordination group for Mutual recognition and Decentralised procedures - Human

Training presentations on Active Substance Master File (ASMF) work sharing procedure

New

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  • 26-10-2018
EDQM

Pharmacopoeial discussion group achievements

The face-to-face meeting of the Pharmacopoeial Discussion Group (PDG) [European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP) and the United States Pharmacopeia (USP)] was hosted by the EDQM in Strasbourg, France, on 2-3 October 2018. WHO participated as Observer.

read more >

  • 25-10-2018
European Comission

Questions and answers related to the United Kingdom's withdrawal from the European Union with regard to the biocides sector

Update Version

read more >

  • 24-10-2018
FDA - Food and Drug Administration

EMA Blocks Aurobindo Pharma From Supplying Irbesartan

EU authorities have increased scrutiny of Chinese API maker Zhejiang Huahai, the valsartan manufacturer linked to the original contamination of APIs used in blood pressure drugs.

read more >

  • 23-10-2018
FDA - Food and Drug Administration

MIT Researchers Develop New Way to Crowd-Source Drug Data

Researchers at MIT say they’ve developed a way for drug sponsors and researchers to share information without compromising private patient details or intellectual property.

read more >

  • 22-10-2018
ECA - European Compliance Academy

EU guidance for new Medical Device Regulation (MDR)

With the coming into force of the Medical Device Regulation (MDR) in 2020, the guidelines 93/42/EEC and 90/385/EEC, which have regulated the field of medical devices so far, will become invalid. Two EU documents define what is going to change and how the changes need to be implemented.

read more >

  • 18-10-2018
DGAV - Direção-Geral de Alimentação e Veterinária

Diethanolamine - Suspension of marketing authorizations for veterinary medicines containing diethanolamine for food-producing animals

The DGAV points out that the sale of any veterinary medicine containing Diethanolamine is prohibited. This prohibition covers not only the supply of such medicines by MA holders and Wholesale Distributors of Medicines and/or Veterinary Medicines, but also by pharmacies and Retail Stores of Veterinary Medicines

read more >

  • 17-10-2018
EMA - European Medicines Agency

EU authorities take further action in ongoing review of sartans: Zheijiang Huahai placed under increased supervision.

 

read more >

  • 16-10-2018
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

Fluoroquinolones and quinolones – new restrictions on use

The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended restricting the use of fluoroquinolone and quinolone antibiotics.

read more >

  • 15-10-2018
FDA - Food and Drug Administration

FDA Breaks Record for Most Generic Approvals

The FDA broke its generic drug approval record yet again, FDA Commissioner Scott Gottlieb said Thursday, reporting that fiscal 2018 has seen the most approvals and tentative approvals.

read more >

  • 12-10-2018
ECA - European Compliance Academy

Version 11 of EU Q&As on Safety Features: Specific Questions on Stickers

The European Commission released version 11 of the questions and answers catalogue on safety features in September 2018. It also addresses the placing of safety features by means of stickers in detail. Get more information about safety features in the revised Q&A document of the EU.

read more >

  • 11-10-2018
EDQM

Ph. Eur. Supplement 9.7: CEP holders are invited to update their applications

Supplement 9.7 of the Ph. Eur is now available.

read more >

  • 10-10-2018
FDA - Food and Drug Administration

FDA: Guidance on Quality Chewables

In vitro disintegration tests should be conducted using established disintegration equipment and methods, the FDA says.

read more >

  • 09-10-2018
ECA - European Compliance Academy

Pharmacovigilance: Be prepared for "Hard Brexit"

The UK Government has released some information regarding the consequences of the Brexit on pharmacovigilance and the establishment of the Qualified Person for Pharmacovigilance (QPPV).

read more >

  • 08-10-2018
CMDh - Co-ordination group for Mutual recognition and Decentralised procedures - Human

Q&As on Pharmacovigilance Legislation

Update

read more >

  • 04-10-2018
ECA - European Compliance Academy

European Pharmacopoeia: New Chapter on Visual Inspection for Visible Particles

The European Pharmacopoeia has published a new chapter on testing of parenterals for visible, particulate matter in Pharmeuropa 30.4.

read more >

  • 03-10-2018
EMA - European Medicines Agency

EMA tracking tool: relocation to Amsterdam - Main milestones

 

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  • 02-10-2018
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

Perguntas e respostas sobre o sistema dos dispositivos de segurança

O sistema dos dispositivos de segurança surgiu com a diretiva 2011/62/EU do Parlamento Europeu e do Conselho, de 8 de junho de 2011 e encontra-se regulado pelo Regulamento Delegado (UE) 2016/161, da Comissão de 2 de outubro de 2015, de aplicação direta na ordem jurídica nacional, e pelo Estatuto do medicamento, na sua redação atual.

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  • 01-10-2018
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

Stock break of the medicine Sinemet - alternatives (postponement)

To ensure that the treatment is available for all patients, it is essential that doctors, pharmacies and distributors manage the available stocks carefully. Patients are also encouraged to pick up the medication at the pharmacies only when needed. It should be noted that any change in treatment should be previously evaluated by the doctor.

read more >

  • 27-09-2018
ECA - European Compliance Academy

Sponsor Oversight of Clinical Trials - How to improve compliance?

There is no "one size fits all" for the management of clinical trials. However, there is a clear requirement according to GCP that the sponsor retains all responsibility for the conduct and reporting of clinical trials. 

read more >

  • 26-09-2018
ECA - European Compliance Academy

New Q&As on Chapter 3 of the EU-GDP Practice Guide (Premises and Equipment)

The European GDP Association has published new Question & Answers on Chapter 3 of the EU-GDP Guide (Premises and Equipment).

read more >

  • 25-09-2018
EDQM

OMCLs release three methods for determination of NDMA in sartans

Since early July 2018 Official Medicines Control Laboratories (OMCLs) of the General European OMCL Network (GEON) have been involved in investigations and actions to address the issues related to the detection of N-nitrosodimethylamine (NDMA) in valsartan. The Network has meanwhile developed methods for the specific testing of nitrosamines in sartans on the basis different analytical principles.

read more >

  • 24-09-2018
EMA - European Medicines Agency

Portugal to also benefit from EU-US mutual recognition agreement for inspections

 

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  • 21-09-2018
ECA - European Compliance Academy

CMDh Clarifications on the Implementation of the Falsified Medicines Directive

In April 2018, the CMDh published a document to clarify questions which arose from the original Q&A document dated March 2017 on the implementation of the Falsified Medicines Directive. Read more about the document "CMDh clarifications on questions received on the implementation of the Falsified Medicines Directive".

read more >

  • 20-09-2018
FDA - Food and Drug Administration

FDA Grants First Approvals Via the Competitive Generic Therapy Pathway

The FDA approved drug products under the Competitive Generic Therapy (CGT) designation for the first time, granting approval to several strengths of Apotex’s potassium chloride oral solution.

read more >

  • 19-09-2018
EMA - European Medicines Agency

Member states contact points for translation review (v.6.11)

 

read more >

  • 18-09-2018
FDA - Food and Drug Administration

FDA Releases Product-Specific Guidances to Foster Generic Competition

One of the most effective ways for the FDA to increase patient access to high quality generics is to offer guidance that promotes the development of cost-saving generics, especially for complex drugs that are difficult to copy, he said.

read more >

  • 17-09-2018
EMA - European Medicines Agency

Update on review of valsartan medicines

  read more >

  • 14-09-2018
FDA - Food and Drug Administration

FDA awards five grants to advance the development of pediatric medical devices

The U.S. Food and Drug Administration announced today that it has awarded five grants totaling up to $6 million per year over the next five years to Pediatric Device Consortia (PDC) across the country that will provide advice and support services to innovators of children's medical devices.

read more >

  • 13-09-2018
ECA - European Compliance Academy

New Questions and Answers on Safety Features - EU Q&As Version 10 published!

The safety features required for the implementation of the Anti-Counterfeit Directive will have to be implemented by the 9th February 2019. The European Commission released version 10 of the questions and answers catalogue on safety features in July 2018. Get more details about the revised Q&A document of the EU on safety features.

read more >

  • 12-09-2018
ECHA

New support pages for industry on obligations for hazardous mixtures

The Poison Centres website has been revamped with new support pages providing stepwise help for industry on how to prepare and submit information on hazardous mixtures.

read more >

  • 11-09-2018
EMA - European Medicines Agency

Dossier requirements for referral, active substance master files (ASMF) and nationally authorised products (NAPs) submissions (PASS107, workshare, signal detection procedures) and ancillary medicinal substances in a medical device

Update

read more >

  • 10-09-2018
EDQM

Revised Guideline on requirements for revision/renewal of CEPs

The revised EDQM ‘Guideline on requirements for revision/renewal of Certificates of Suitability to the European Pharmacopoeia Monographs’ (PA/PH/CEP (04) 2 7R) will enter into force in January 2019.

read more >

  • 07-09-2018
FDA - Food and Drug Administration

Sanofi’s Treatment for Blood-Clotting Disorder Approved in Europe

The authorization marks Sanofi’s first approval for a nanobody-based medicine

read more >

  • 06-09-2018
FDA - Food and Drug Administration

FDA Issues Guidance on Controlling Elemental Impurities in Drugs

The FDA finalized its recommendations on how drug sponsors submitting applications should control elemental impurities in their drug products.

read more >

  • 05-09-2018
EMA - European Medicines Agency

Pre-notification check for type IA variations: ensuring the quality of veterinary type IA variation submissions

Update

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  • 03-09-2018
ECA - European Compliance Academy

What information is included in a CEP?

The "Certificate of suitability to the Monographs of the European Pharmacopoeia" (CEP) contains information on an active pharmaceutical substance with regard to the European Pharmacopoeia. It is an important document of the authorisation application. Read more about what information is relevant for a CEP and what do CEP holders and authorisation applicants have to consider.

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  • 28-08-2018
FDA - Food and Drug Administration

FDA Issues Draft Guidance on Export Certificates for Device

In cases where the denial is specifically because of a facility’s noncompliance with GMPs, the agency will provide a “substantive summary” of the failures identified.

read more >

  • 27-08-2018
FDA - Food and Drug Administration

FDA Suggests New Flexibility for Blinding Cancer Trials

Cancer patients in clinical trials should be told whether they’ve been given placebos or experimental drugs if their tumors reappear or get worse—and patients and researchers should be told if sponsors are worried experimental drugs may be triggering bad reactions, the FDA says in new draft guidance released Thursday.

read more >

  • 24-08-2018
EMA - European Medicines Agency

Keeping medicines safe Keeping medicines safe

How EMA monitors medicines once they are on the market

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  • 23-08-2018
ECA - European Compliance Academy

EMA publishes list of contact details for pharmacovigilance enquiries

The EMA published information extracted from the Article 57 database (xEVMPD) in the form of an Excel document. The file contains a complete list of all medicines authorized in the EEA with marketing authorization holders' dedicated contact details for pharmacovigilance enquiries.

read more >

  • 22-08-2018
EMA - European Medicines Agency

Update on medicines containing valsartan from Zhejiang Tianyu

Company no longer authorised to manufacture valsartan active substance for EU medicines due to presence of NDMA. 

read more >

  • 21-08-2018
EMA - European Medicines Agency

Launch of the new EudraVigilance system: questions and answers from stakeholders

Update

read more >

  • 20-08-2018
FDA - Food and Drug Administration

FDA approves first generic version of EpiPen

The U.S. Food and Drug Administration today approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions, including those that are life-threatening (anaphylaxis), in adults and pediatric patients who weigh more than 33 pounds.

read more >

  • 17-08-2018
ECA - European Compliance Academy

New WHO guideline on medical devices and IVDs

On 76 pages spread over five chapters, the WHO has published a finalised regulatory framework for medical devices, including In-vitro-Diagnostics (IVDs), with the title "WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices".

read more >

  • 16-08-2018
FDA - Food and Drug Administration

Pair of Anti-Malaria Drugs Win Approval

The sponsors will conduct post-marketing studies to make sure their drugs are safe and effective for children, elders and the obese. 

read more >

  • 14-08-2018
FDA - Food and Drug Administration

FDA approves first-of-its kind targeted RNA-based therapy to treat a rare disease

The U.S. Food and Drug Administration today approved Onpattro (patisiran) infusion for the treatment of peripheral nerve disease (polyneuropathy) caused by hereditary transthyretin-mediated amyloidosis (hATTR) in adult patients. 

read more >

  • 13-08-2018
CMDh - Co-ordination group for Mutual recognition and Decentralised procedures - Human

CMDh procedural advice on changing the RMS

Update

read more >

  • 10-08-2018
FDA - Food and Drug Administration

FDA approves treatment for two rare types of non-Hodgkin lymphoma

The U.S. Food and Drug Administration today approved Poteligeo (mogamulizumab-kpkc) injection for intravenous use for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy.

read more >

  • 09-08-2018
EMA - European Medicines Agency

Electronic submission of Article 57(2) data: questions and answers

Update

read more >

  • 08-08-2018
ECA - European Compliance Academy

European Commission publishes revised Version of EU GMP Guideline Annex 2

As consequence of the adopted new regulations of GMP for ATMPs, the European Commission published a revised version of the Annex 2 "Manufacture of Biological active substances and Medicinal Products for Human Use".

read more >

  • 07-08-2018
CMDh - Co-ordination group for Mutual recognition and Decentralised procedures - Human

Best Practice Guide for the Reference Member State in the MRP/DCP

Update read more >

  • 06-08-2018
UK Government

Early access to medicines scheme: expired scientific opinions

Medicines that were granted a positive opinion under the early access to medicines scheme (EAMS) which has now expired.

read more >

  • 03-08-2018
EMA - European Medicines Agency

Brexit preparedness: EMA to further temporarily scale back and suspend activities

The European Medicines Agency (EMA) will launch the next phase of its business continuity plan on 1 October 2018 at the latest. This will allow the Agency to safeguard core activities related to the evaluation and supervision of medicines, while it has to intensify its preparations for the physical move to Amsterdam in March 2019 and cope with significant staff loss.

read more >

  • 02-08-2018
ECA - European Compliance Academy

Cooperation of international authorities for inspecting API manufacturers

The aim of the International API Inspection Programme is the cooperation of authorities in monitoring and controlling API manufacturers. Read here, by which measures an optimised bundling and efficiency enhancement of the regulatory supervision of API facilities via GMP inspections are to be reached.

read more >

  • 01-08-2018
ECA - European Compliance Academy

Collecting Patient Experience Data for Product Development

The FDA recently released a guidance on patient experience data from patients, caregivers, clinicians and others for product development and regulatory decision-making.

read more >

  • 31-07-2018
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

Claims relating to cosmetic products

 

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  • 30-07-2018
EMA - European Medicines Agency

EudraVigilance: how to register

Pharmaceutical companies holding or applying for a marketing authorisation in the European Economic Area (EEA), sponsors of clinical trials and national competent authorities in the EEA need to register with EudraVigilance for the electronic data interchange of pharmacovigilance information. The registration process is a prerequisite for electronic reporting.

read more >

  • 27-07-2018
EMA - European Medicines Agency

IT systems unavailable from 27 to 30 July 2018

EMA website and online applications will be temporarily unavailable

read more >

  • 26-07-2018
ECA - European Compliance Academy

United Kingdom wants to remain in the EMA

It's official: the United Kingdom wants to remain in the EMA. This can be gathered from a recent statement by the government.

read more >

  • 25-07-2018
FDA - Food and Drug Administration

Roche’s Tecentriq Gets Breakthrough Therapy Status

The FDA granted a breakthrough therapy designation to Roche’s Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) to treat hepatocellular carcinoma. 

read more >

  • 24-07-2018
FDA - Food and Drug Administration

FDA approves first targeted treatment for patients with relapsed or refractory acute myeloid leukemia who have a certain genetic mutation

The U.S. Food and Drug Administration today approved Tibsovo (ivosidenib) tablets for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. This is the first drug in its class (IDH1 inhibitors) and is approved for use with an FDA-approved companion diagnostic used to detect specific mutations in the IDH1 gene in patients with AML.

read more >

  • 23-07-2018
CMDh - Co-ordination group for Mutual recognition and Decentralised procedures - Human

Template for RMS change

  

read more >

  • 20-07-2018
European Comission

EU and Japan reinforce their collaboration on inspections of medicine manufacturers

Update of 2004 mutual recognition agreement extends scope to sterile products, active pharmaceutical ingredients and biologicals including vacines.

read more >

  • 19-07-2018
EDQM

CEP document revised: “Implementation of ICH Q3D in the Certification Procedure”

The EDQM document “Implementation of ICH Q3D in the Certification Procedure” has been revised based on experience gained by EDQM since the initial implementation of the policy. Its implementation date is the 1st September 2018.

read more >

  • 18-07-2018
EMA - European Medicines Agency

EMA’s proactive publication of clinical data a success

First report on unprecedented transparency policy shows high user satisfaction.

read more >

  • 17-07-2018
FDA - Food and Drug Administration

FDA approves the first drug with an indication for treatment of smallpox

The U.S. Food and Drug Administration today approved TPOXX (tecovirimat), the first drug with an indication for treatment of smallpox. Though the World Health Organization declared smallpox, a contagious and sometimes fatal infectious disease, eradicated in 1980, there have been longstanding concerns that smallpox could be used as a bioweapon. 

read more >

  • 16-07-2018
EMA - European Medicines Agency

New versions of the 4 electronic Application Forms (eAF v. 1.23)

This release includes further integration with OMS for organisation data in proposed and present part of Variation form and other NTA changes. This new version, 1.23 of the forms can be used as of today (13th July 2018) and will fully replace the version 1.22.0.1 after transitional period, on 15 October 2018. The version of the form should not be changed during an ongoing procedure.

read more >

  • 13-07-2018
FDA - Food and Drug Administration

FDA Issues Advice on Limited Population Pathway for Antimicrobials

The FDA released draft guidance for sponsors who want to use the agency’s limited population pathway for antibacterial and antifungal drugs.

read more >

  • 12-07-2018
EMA - European Medicines Agency

Brexit-related guidance for companies

 

read more >

  • 11-07-2018
EDQM

Ph.Eur. Supplement 9.6 available now

The 9.6 supplement of European Pharmacopoeia is now available and will be applicable in 38 European countries as from 01 January 2019.

read more >

  • 10-07-2018
FDA - Food and Drug Administration

FDA Issues Draft Labeling Guidance on Indications and Usage

The FDA released draft guidance outlining the information sponsors should include on the Indications and Usage section of drug and biologics labeling.

read more >

  • 09-07-2018
EMA - European Medicines Agency

Pre-authorisation guidance

 

read more >

  • 06-07-2018
ECA - European Compliance Academy

IMPs: EMA updates timeline for portal and database

The EMA has announced a new timeline for the application of the Clinical Trials Regulation due to the EMA`s move to Amsterdam because of the Brexit.

read more >

  • 05-07-2018
ECA - European Compliance Academy

ICH Q13 supports continuous manufacturing

On 22 June, it became official: the International Council for Harmonisation (ICH) announced in a press release that with the new Guideline ICH Q13, they would support the introduction of continuous manufacturing processes into the pharmaceutical industry.

read more >

  • 04-07-2018
FDA - Food and Drug Administration

FDA Suggests Alternatives for Demonstrating CGMP Compliance for Combination Products

The FDA released a list of alternative suggestions for complying with CGMP requirements for drug combination products that covers stability testing, release for distribution, reserve samples and special testing requirements.

read more >

  • 03-07-2018
EMA - European Medicines Agency

First two CAR-T cell medicines recommended for approval in the European Union

The European Medicines Agency (EMA) has recommended the first two marketing authorisations for chimeric antigen receptors (CAR) T-cells medicines in the European Union (EU). Kymriah (tisagenlecleucel) and Yescarta (axicabtagene ciloleucel) are advanced therapies for blood cancer. They belong to a new generation of personalised cancer immunotherapies that are based on collecting and modifying patients’ own immune cells to treat their cancer.

read more >

  • 02-07-2018
FDA - Food and Drug Administration

FDA: Oncology Radiopharmaceutical Labeling Must Include Genotoxicity

Labeling for oncology radiopharmaceuticals must include information on the potential for genotoxicity and adverse reproductive toxicity, the FDA said in new draft guidance.

read more >

  • 29-06-2018
ICH

ICH M9 reaches Step 2b of the ICH Process

The ICH M9 Biopharmaceutics Classification System-based Biowaivers reached Step 2b of the ICH Process in June 2018 and now enters the consultation period.

read more >

  • 28-06-2018
ECA - European Compliance Academy

Batch Release without a QP - Is this possible?

Batch certification by a QP is one of the essential requirements in the EU GMPs. However one company in Spain has released products to the market without the QP - with reasonable consequences.

read more >

  • 27-06-2018
FDA - Food and Drug Administration

FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy

The U.S. Food and Drug Administration approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older. This is the first FDA-approved drug that contains a purified drug substance derived from marijuana. It is also the first FDA approval of a drug for the treatment of patients with Dravet syndrome.

read more >

  • 26-06-2018
EMA - European Medicines Agency

Procedure for orphan-medicinal-product designation: Guidance for sponsors submitting an application via the current existing submission process until 19 Sept 2018

 

read more >

  • 25-06-2018
FDA - Food and Drug Administration

FDA approves automated insulin delivery and monitoring system for use in younger pediatric patients

The U.S. Food and Drug Administration expanded the approval of the MiniMed 670G hybrid closed looped system, a diabetes management device that is intended to automatically monitor glucose (sugar) and provide appropriate basal insulin doses with little or no input from the user, to include individuals aged 7 to 13 with type 1 diabetes. The FDA originally approved this device in September 2017 for use in patients 14 years of age and older with type 1 diabetes.

read more >

  • 22-06-2018
PIC/S - Pharmaceutical Inspection Co-operation Scheme

Revision of PIC/S GMP Guide (PE 009-14)

The revised Chapters 3, 5, & 8 of the PIC/S GMP Guide are based on the equivalent Chapters of the EU GMP Guide with some minor differences in terms of language. These Chapters of the PIC/S GMP Guide have now been aligned with principles of Quality Risk Management.

read more >

  • 21-06-2018
ECA - European Compliance Academy

Quality defects: EMA updates Defective Product Report Template

The European Medicines Agency (EMA) has updated their document for reporting quality defects in drug products.

read more >

  • 20-06-2018
FDA - Food and Drug Administration

FDA Issues Questions and Answers on Implementing ICH S9 Guidance

Cancer drug sponsors facing challenges in implementing the ICH S9 guidance on nonclinical evaluations of their drugs may find answers in a new ICH guidance released by the FDA.

read more >

  • 19-06-2018
FDA - Food and Drug Administration

Time Is Running Out to Prepare for New EU MDR/IVDR: MedTech Europe

One year after the EU finalized its new medical device and in vitro diagnostics regulations there has been little progress in helping industry transition to the new regulations, according to MedTech Europe.

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  • 18-06-2018
PIC/S - Pharmaceutical Inspection Co-operation Scheme

New PIC/S guidance on GMP inspection reliance based on draft by ICMRA with aim to maximise inspection resources for GMP compliance of overseas facilities

PIC/S has adopted a new guidance on GMP inspection reliance (PI 048-1), which entered into force on 1 June 2018.

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  • 15-06-2018
ECA - European Compliance Academy

Falsified Medicines Directive - securPharm status report for 2018

There isn't much time left until the safety features required in the future will have to be implemented in order to comply with the Falsified Medicines Directive which will enter into force on 9 February, 2019. The German initiative securPharm has published a status report in this issue for the year 2018.

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  • 14-06-2018
ECA - European Compliance Academy

Investigational Medicinal Products (IMP): Applicability of the GDP-Guidelines

A new draft EMA Guideline requires that GDP-Guidelines for medicinal products should be taken into consideration for IMP shipments.

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  • 12-06-2018
EMA - European Medicines Agency

Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use

June 2018

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  • 11-06-2018
EDQM

Monograph for Water, highly purified (1927) to be suppressed from the European Pharmacopoeia

Following a decision taken by the European Pharmacopoeia (Ph. Eur.) Commission at its 160th session (March 2018), the monograph for Water, highly purified (HPW) will be suppressed on 1 April 2019 from the Ph. Eur. The monograph suppression is a consequence of the recent revision of the monograph for Water for injections (0169), which now allows for purification processes equivalent to distillation for producing water for injections (WFI), in addition to distillation. Hence, the HPW monograph is a duplication of the WFI monograph in terms of quality requirements and production methods, and as such became redundant.

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  • 07-06-2018
ICH

ICH Q3D(R1) revision reaches Step 2b of the ICH Process

The ICH Q3D(R1) Revision of the ICH Q3D Guideline for Elemental Impurities reached Step 2b of the ICH Process in May 2018 and now enters the consultation period.

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  • 04-06-2018
CMDh - Co-ordination group for Mutual recognition and Decentralised procedures - Human

List of safety concerns per approved Risk Management Plan (RMP) of active substances per product

Update

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  • 01-06-2018
ECA - European Compliance Academy

Unexpected deviation: what is the Role of the QP?

The European Medicines Agency (EMA) has updated its Questions and Answers Section with an amendment to further clarify the role of the QP in the context of handling unexpected deviations.

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  • 30-05-2018
EMA - European Medicines Agency

List of centrally authorised products requiring a notification of a change for update of annexes

Update.

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  • 28-05-2018
EMA - European Medicines Agency

Development of antibiotics for children - towards a global approach

The European Medicines Agency (EMA), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and the United States' Food and Drug Administration (FDA) are co-organising a workshop to discuss the development of antibiotics for children.

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  • 25-05-2018
EDQM

Towards harmonisation in the classification of medicines across Europe

The Committee of Ministers of the Council of Europe adopted a revised Resolution on the classification of medicines as regards their supply. It calls on the States Parties to the Convention on the Elaboration of a European Pharmacopoeia (Ph. Eur. Convention) to regularly provide information on their national classifications of medicines for inclusion in the Melclass database and follow the recommendations to classify active substances on the basis of the supply conditions of the medicines that contain them, as listed in the database. The new Resolution CM/Res(2018)1, which supersedes the previous Resolution ResAP(2007)1 from 2007, will continue to play a key role in providing 800 million citizens across Europe with safe access to medicines and to support national authorities in ensuring the appropriate and responsible use of medicines.

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  • 24-05-2018
EDQM

New EDQM guideline "How to read a CEP"

EDQM has elaborated the guideline “How to read a CEP” with the aim of describing in detail the information conveyed on the Certificates of suitability to the Monographs of the European Pharmacopoeia (CEP). This document is intended to give Industry and Competent Authorities clarification on the meaning of the statements laid down on the CEPs.

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  • 23-05-2018
FDA - Food and Drug Administration

FDA Issues Final Guidance on GMPs for APIs

The FDA released final guidance on its Q7 guidelines on good manufacturing practices for active pharmaceutical ingredients, using a question and answer format to clarify the document developed through the International Conference on Harmonization.

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  • 22-05-2018
European Comission

Targeted stakeholder consultation on duplicate marketing authorisations for biological medicinal products

 

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  • 21-05-2018
FDA - Food and Drug Administration

FDA approves novel preventive treatment for migraine

The U.S. Food and Drug Administration approved Aimovig (erenumab-aooe) for the preventive treatment of migraine in adults. The treatment is given by once-monthly self-injections. Aimovig is the first FDA-approved preventive migraine treatment in a new class of drugs that work by blocking the activity of calcitonin gene-related peptide, a molecule that is involved in migraine attacks.

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  • 18-05-2018
FDA - Food and Drug Administration

FDA approves the first non-opioid treatment for management of opioid withdrawal symptoms in adults

The U.S. FDA approved Lucemyra (lofexidine hydrochloride) for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults. While Lucemyra may lessen the severity of withdrawal symptoms, it may not completely prevent them and is only approved for treatment for up to 14 days. Lucemyra is not a treatment for opioid use disorder (OUD), but can be used as part of a broader, long-term treatment plan for managing OUD.

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  • 17-05-2018
ECA - European Compliance Academy

EU Data Protection Regulation - Impact on Clinical Trials & Pharmacovigilance

The EU Data Protection Regulation will apply from May 25, 2018. It will introduce new data protection requirements in the EU as well as substantial fines for breaches of the data protection rules.

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  • 16-05-2018
EMA - European Medicines Agency

Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use

May 2018

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  • 15-05-2018
FDA - Food and Drug Administration

FDA expands approval of Gilenya to treat multiple sclerosis in pediatric patients

The U.S. Food and Drug Administration approved Gilenya (fingolimod) to treat relapsing multiple sclerosis (MS) in children and adolescents age 10 years and older. This is the first FDA approval of a drug to treat MS in pediatric patients.

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  • 14-05-2018
FDA - Food and Drug Administration

FDA Clarifies the Term ‘Outsourcing Facility’ and Requirements for 503A Compounders

As part of its increased focus on drug compounding, the FDA issued a final guidance clarifying the term “outsourcing facility” and detailing requirements for compounders operating under 503A that are next to an outsourcing facility.

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  • 11-05-2018
FDA - Food and Drug Administration

Roche Gains Priority Review for Tecentriq Combo Treatment in Cancer Patients

The FDA granted priority review for Roche’s Tecentriq (atezolizumab) used in combination with Avastin (bevacizumab), paclitaxel and chemotherapy for the first-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC) patients.

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  • 10-05-2018
EMA - European Medicines Agency

Questions and answers: Good manufacturing practice

This page lists the European Medicines Agency's answers to frequently asked questions, as discussed and agreed by the Good Manufacturing Practice (GMP) / Good Distribution Practice (GDP) Inspectors Working Group. The section on “EU GMP guide annexes: Supplementary requirements: Annex 16” was updated.

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  • 09-05-2018
EMA - European Medicines Agency

Two years of PRIME

In the two years since its launch, the PRIority Medicines scheme (PRIME) of the European Medicines Agency (EMA) has succeeded in driving innovation and improved the efficiency of the development process in therapeutic areas with the most pressing unmet medical needs. The goal is to support and optimise medicine development, so that patients whose diseases cannot be treated or who need better treatment options have access to new medicines that enable them to live healthier lives.

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  • 08-05-2018
CMDh - Co-ordination group for Mutual recognition and Decentralised procedures - Human

Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP

 

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  • 07-05-2018
European Comission

Evaluation of EMA fee system for the approval and monitoring of medicines:

Public consultation launched today.

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  • 04-05-2018
EMA - European Medicines Agency

EMA 2017 annual report published

The 2017 annual report published today provides an overview of the work of the European Medicines Agency (EMA) and highlights last year’s major achievements in protecting and promoting public and animal health in the European Union (EU).

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  • 03-05-2018
ECA - European Compliance Academy

Quality Risk Management: What Inspectors are looking for

ICH Q9 is the major guideline providing principles and examples of tools for Quality Risk Management (QRM). But how do competent authorities look at these QRM systems in their GMP inspections?

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  • 02-05-2018
EMA - European Medicines Agency

Q & A: Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities - updated 27/04/2018

Questions and answers on implementation of risk-based prevention of cross-contamination in production and ‘Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities’. 

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  • 30-04-2018
EMA - European Medicines Agency

Updated rules for clinical development of vaccines

EMA launches public consultation on revised guideline on clinical evaluation of vaccines. 

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  • 27-04-2018
EMA - European Medicines Agency

The European Medicines Agency and the Netherlands agree on Seat Agreement

The European Medicines Agency (EMA) and the Netherlands have finalised the text of a Seat Agreement which describes how the Agency, its bodies and its employees will be treated by the Dutch Government once they start operating in the Netherlands.

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  • 26-04-2018
Diário da República

Decree-Law no. 26/2018 – National Official Journal no. 80/2018, Series I of 2018-04-24

Changes the legal status of the medicinal products for human use, transposing Directive (EU) 2017/1572.

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  • 24-04-2018
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

Public hearing about medicinal products containing quinolones and fluoroquinolones

It is ongoing the safety review of the medicinal products containing quinolones and fluoroquinolones due to the occurrence of cases of severe and persistent adverse reactions which mostly affect the muscles, joints and the nervous system.

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  • 23-04-2018
FDA - Food and Drug Administration

FDA Issues Final Guidance on API Good Manufacturing Practices Guidelines

The FDA released final guidance on its Q7 guidelines on good manufacturing practices for APIs, using a question and answer format to clarify the document developed through the International Conference on Harmonization.

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  • 20-04-2018
FDA - Food and Drug Administration

FDA Clears First Device to Use Artificial Intelligence to Identify Diabetic Retinopathy

The FDA cleared the first medical device to use artificial intelligence to measure eye disease diabetic retinopathy in diabetic adults.

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  • 19-04-2018
ECA - European Compliance Academy

Auditing Starting Materials - new APIC Guideline defines Standards

The use of starting materials in the production process for active pharmaceutical ingredients marks the starting point for GMP. But how can the quality of starting materials be ensured?

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  • 18-04-2018
Diário da República

Resolution no. 481/2018 – National Official Journal no. 75/2018, Series II of 2018-04-17

Change of the list of Previous Notification of transactions of medicinal products to outside the country.

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  • 17-04-2018
EMA - European Medicines Agency

Meeting highlights from the PRAC: 9-12 April 2018

The Pharmacovigilance Risk Assessment Committee (PRAC) has started a review of the risk of dosing errors with methotrexate medicines, used to treat cancers such as acute lymphoblastic leukaemia and various inflammatory conditions including rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis and psoriatic arthritis.

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  • 16-04-2018
EMA - European Medicines Agency

Increasing oversight of API manufacturing through international collaboration

The European Medicines Agency (EMA) and its European and international partners have successfully strengthened their interactions to improve the oversight of active pharmaceutical ingredient (API) manufacturers worldwide, as highlighted in the International API inspection programme report for 2011-2016, published today. APIs are the substances responsible for the activity of a medicine.

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  • 13-04-2018
EMA - European Medicines Agency

Redistribution of UK’s portfolio of centrally authorised products

The EU27 Member States and the European Medicines Agency (EMA) have completed the reallocation of the medicines for which the United Kingdom’s (UK) Medicines and Healthcare products Regulatory Agency (MHRA) and Veterinary Medicines Directorate (VMD) are currently rapporteur or co-rapporteur appointed by the scientific committees to coordinate the evaluation of a medicine.

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  • 12-04-2018
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

Transitional period applicable to the new Regulations of Medical Devices and In Vitro Diagnosis Medical Devices

In the context of the group of Competent Authorities for Medical Devices and In Vitro Diagnosis Medical Devices in what concerns inspection of the market and clinical investigation (CAMD), a Task Force was established (CAMD Transition Sub Group), with the purpose of discussing the content, harmonize the interpretation and clarify the rules related to the transitional period applicable to the new Regulations of Medical Devices and In Vitro Diagnosis Medical Devices.

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  • 11-04-2018
EDQM

Revised: guideline “Validation of Computerised Systems”

Since the adoption of the first version of the “Validation of Computerised Systems” guideline in May 2009, most of the Network members have introduced computerised systems e.g. Laboratory Information Management Systems (LIMS) and electronic document management systems into their labs which have become commonly used working tools of the Network. For that reason and also based on experiences gained during Mutual Joint Audits, the guideline has been profoundly restructured and revised.

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  • 10-04-2018
EMA - European Medicines Agency

Draft addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections to address paediatric-specific clinical data requirements - First version

Draft: consultation open

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  • 09-04-2018
ECA - European Compliance Academy

How to prepare for an inspection?

GDP inspections by supervisory authorities have grown in number and intensity. Many partners in the distribution chain also have customer audits to face. What does the ideal preparation for a GDP inspection look like?

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  • 06-04-2018
UK Government

MHRA GxP Data Integrity Definitions and Guidance for Industry

MHRA has produced draft GxP data integrity guidance for industry and we welcome your comments.

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  • 05-04-2018
EMA - European Medicines Agency

Public consultation concerning the EU template for GMP non-compliance statement

Deadline for comments: 15/05/2018

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  • 04-04-2018
EDQM

Rapid implementation of the monograph Products of fermentation (1468).

Due to the public health risk associated with histamine contamination, further requirements related to the quality of raw materials have been added to the Raw materials section of the monograph on Products of fermentation (1468). The implementation date for the revised monograph was 1 April 2018.

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  • 03-04-2018
FDA - Food and Drug Administration

FDA expands approval of Blincyto for treatment of a type of leukemia in patients who have a certain risk factor for relapse

The U.S. Food and Drug Administration granted accelerated approval to Blincyto (blinatumomab) to treat adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission but still have minimal residual disease (MRD). MRD refers to the presence of cancer cells below a level that can be seen under the microscope. In patients who have achieved remission after initial treatment for this type of ALL, the presence of MRD means they have an increased risk of relapse.

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  • 02-04-2018
European Comission

Technical expert seminar on pharmaceuticals related matters, following UK withdrawal (8 March 2018)

The European Commission DG SANTE convened a technical expert seminar on pharmaceuticals related matters in order to discuss matters related to preparedness of the UK withdrawal.

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  • 29-03-2018
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

Retinoids – new recommendations on the risks of teratogenicity and neuropsychiatric disorders

The European Medicines Agency (EMA) has completed its review of retinoid medicines, and confirmed that an update of measures for pregnancy prevention is needed. In addition, a warning on the possibility that neuropsychiatric disorders (such as depression, anxiety and mood changes) may occur should be included in the prescribing information for oral retinoids.

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  • 28-03-2018
EMA - European Medicines Agency

EU recommendations for 2018/2019 seasonal flu vaccine composition

The European Medicines Agency (EMA) has issued the European Union (EU) recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from autumn 2018.

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  • 27-03-2018
EMA - European Medicines Agency

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 March 2018

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended six medicines for approval, including one orphan medicine, at its March 2018 meeting.

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  • 26-03-2018
CMDh - Co-ordination group for Mutual recognition and Decentralised procedures - Human

January 2018 CMDh Minutes

 

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  • 22-03-2018
ECA - European Compliance Academy

ECA Data Integrity Task Force issues Version 2.0 of Data Integrity Guide

With the authorities' increasing attention to data governance and data integrity the ECA's Data Integrity Task Force's just released version 2.0 of its Data Integrity Guide provides an ideal tool for implementing data integrity in practice.

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  • 21-03-2018
EMA - European Medicines Agency

Clinical Trial Regulation

The way clinical trials are conducted in the European Union (EU) will undergo a major change when the Clinical Trial Regulation comes into application in 2019. The Regulation harmonises the assessment and supervision processes for clinical trials throughout the EU, via an EU portal and database. The European Medicines Agency (EMA) will set up and maintain the portal and database, in collaboration with the Member States and the European Commission.

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  • 19-03-2018
UK Government

Common issues identified during clinical trial applications

This guidance identifies common issues with validation and assessment of clinical trial applications and how to avoid them.

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  • 16-03-2018
CMDh - Co-ordination group for Mutual recognition and Decentralised procedures - Human

Additional Data requested for New Applications in the Mutual Recognition and Decentralised Procedures

 

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  • 15-03-2018
FDA - Food and Drug Administration

FDA Adopts Final ICH M7(R1) Mutagenic Carcinogen Guideline

Potential or actual impurities in drugs should be studied for their mutagenic properties, according to a revision to an ICH guideline addendum on mutagenic carcinogens, now adopted by the FDA.

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  • 14-03-2018
EDQM

European Pharmacopoeia Reference Standards recently released

9 new Ph. Eur. Reference Standards (RS) were released in February 2018.

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  • 13-03-2018
FDA - Food and Drug Administration

FDA Releases Finalized Q&A Guidance on Choosing Chemical Drug Starting Materials

The FDA finalized a Q&A guidance clarifying the International Council for Harmonization’s November 2012 Q11 guidance on development and manufacture of drug substances — giving recommendations for information that should be provided in authorization applications for starting materials.

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  • 12-03-2018
CMDh - Co-ordination group for Mutual recognition and Decentralised procedures - Human

CMDh procedural advice on changing the RMS - Track version

In exceptional circumstances, a Marketing Authorisation Holder (MAH) may request a change of the Reference Member State (RMS). The change may be needed when a MAH or a subsidiary responsible for the communication on behalf of the MAH has been closed in the RMS, or when a medicinal product has more than one RMS for the different pharmaceutical forms of the medicinal product, or, subject to clear justification, due to the sunset clause in the RMS. These are examples and other reasons might be justified.

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  • 05-03-2018
EMA - European Medicines Agency

Four more EU Member States benefit from EU-US mutual recognition agreement for inspections

The mutual recognition agreement between the European Union (EU) and the United States (US) to recognise inspections of manufacturing sites for human medicines conducted in their respective territories is progressing as planned. The US Food and Drug Administration (FDA) confirmed the capability of four more EU Member States (Czech Republic, Greece, Hungary, and Romania) to carry out good manufacturing practice (GMP) inspections at a level equivalent to the US. There are now a total of 12 Member States whose inspection results the FDA can rely on to replace their own inspections.

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  • 02-03-2018
ECA - European Compliance Academy

Revision of EU GMP Chapter 1 to enhance Quality Risk Management

The European Medicines Agency (EMA) is planning to revise Chapter 1 of the EU-GMP Guidelines. In the new document, risk-based approaches will be included to prevent drug shortages.

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  • 28-02-2018
FDA - Food and Drug Administration

FDA to Require GCP Compliance for Device Trials That Rely on Foreign Clinical Data

Next year, the FDA will begin to require that data from medical device studies conducted outside the U.S. be gathered in accordance with good clinical practices, including review and approval from an independent ethics committee and well-documented informed consent.

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  • 27-02-2018
EMA - European Medicines Agency

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 February 2018

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended five medicines for approval, including two orphan medicines, at its February 2018 meeting.

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  • 26-02-2018
EDQM

New standards for haemophilia patients care in Council of Europe Resolution

The Council of Europe’s decision-making body, the Committee of Ministers, adopted Resolution CM/Res(2017)43 on principles concerning haemophilia therapies at the end of 2017. Elaborated by the European Committee on Blood Transfusion (CD-P-TS) on the basis of the recommendations from the Wildbad Kreuth Initiative IV meeting « Optimal use of clotting factors and platelets » of 2016*, the new Resolution replaces Resolution CM/Res (2015)3 on the same subject and calls on governments to take into account specific principles for the treatment of haemophilia and care for haemophilia patients.

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  • 23-02-2018
UK Government

Medical devices: UK notified bodies

UK notified bodies listed under medical device directives.

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  • 22-02-2018
ECA - European Compliance Academy

EMA's GMP Plans for 2018

The European Medicines Agency has published the 2018 Work Plan. The EMA plans some new guidance and some revisions to existing requirements.

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  • 21-02-2018
EMA - European Medicines Agency

Highlights from the twelfth industry stakeholder platform on the operation of pharmacovigilance in the European Union

 

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  • 20-02-2018
EDQM

New versatile reference standard for equipment qualification

The EDQM announces the availability of a new reference standard: Sodium aminosalicylate dihydrate for equipment qualification CRS 1 replacing the former Amoxicillin trihydrate for performance verification CRS, which will be discontinued as of 1 April 2018.

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  • 19-02-2018
European Comission

Health-EU Newsletter - Assessing health technology in the EU: Commission proposes to reinforce cooperation amongst Member States

 

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  • 16-02-2018
ECA - European Compliance Academy

Quality Risk Management: What Inspectors are looking for

ICH Q9 is the major guideline providing principles and examples of tools for Quality Risk Management (QRM). But how do competent authorities look at these systems in their GMP inspections? 

read more >

  • 15-02-2018
European Comission

New Q&A on safety features concerning falsified medicines

Version 9

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  • 14-02-2018
FDA - Food and Drug Administration

FDA Publishes Guidance on Microbiology Data for Antibacterial Drugs

Sponsors of systemic antibacterial drugs should evaluate their products against test panels of relevant bacteria and against approved drugs with similar mechanisms of activity, the FDA said, in a newly revised guidance.

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  • 08-02-2018
ECA - European Compliance Academy

How is the Data Governance System to be implemented in your Company?

The PIC/S draft guideline "Good Practices for Data Management and Integrity" requires every company to have a data governance system in place in addition to their existing QM system. But how can such a system be implemented?

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  • 07-02-2018
ECA - European Compliance Academy

Question & Answers on Chapter 1 QUALITY MANAGEMENT of the EU Good Distribution Practice Guideline

The European GDP Guideline which has been published in a revised version on 7 March 2013 has caused a lot of discussion since then. Many requirements leave room for interpretation. On the GDP Association Webpage a section has been set up with frequently asked questions (FAQs).

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  • 06-02-2018
UK Government

UK and China sign Memorandum of Understanding on Medicine and Device Regulation

The agreement pledges new areas of cooperation such as an exchange of learning from the accelerated access review (AAR) and how to effectively regulate the trading of medicines online.

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  • 05-02-2018
EMA - European Medicines Agency

Evaluation of advanced therapy medicines

The European Medicines Agency (EMA) has updated its procedural advice on the evaluation of advanced therapy medicinal products (ATMPs). The update aims to streamline some procedural aspects, strengthen collaboration between EMA’s scientific committees and address specific needs of ATMP developers in the evaluation procedure for initial marketing authorisations, to help developers of these medicines – often small and medium-sized enterprises (SMEs) or academic spin-offs – navigate the regulatory process in the EU.

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  • 02-02-2018
ECA - European Compliance Academy

Regulatory requirements for Audit Trail Reviews

Audit Trails and their reviews are an important requirement in the current GMP policies. Specific requirements can be found in a number of guidelines, these days. Despite that, many questions about the specific implementation of this complex topic into practice remain.

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  • 01-02-2018
CMDh - Co-ordination group for Mutual recognition and Decentralised procedures - Human

December 2017 CMDh Minutes

 

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  • 31-01-2018
EDQM

The EDQM "Guidance for electronic submissions for CEPs applications" has been revised and application forms have been updated accordingly

The EDQM has revised the document «Guidance for electronic submissions for Certificates of Suitability (CEPs) applications».

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  • 30-01-2018
EMA - European Medicines Agency

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 January 2018

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended seven medicines for approval, including one orphan medicine, at its January 2018 meeting.

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  • 29-01-2018
Diário da República

Ordinance no. 36/2018 – National Official Journal no. 19/2018, Series I of 2018-01-26

Determines that the measures of treatment of patients with ichthyosis benefit from an exceptional reimbursement regimen.

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  • 26-01-2018
FDA - Food and Drug Administration

FDA Clarifies Conditions for Mixing, Diluting or Repackaging Biologics

The FDA issued a final guidance on approved biologics that are mixed, diluted or repackaged, noting when the agency will not take action against violations of its standard rules on product misbranding and false and misleading labeling.

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  • 25-01-2018
EFSA - European Food Safety Authority

EFSA confirms health concerns for hydroxyanthracene derivatives in food

Some substances belonging to a group of plant ingredients known as hydroxyanthracene derivatives can damage DNA and may cause cancer, said EFSA after assessing their safety when added to food.

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  • 24-01-2018
ECHA

236 substances shortlisted for possible regulatory action

ECHA has selected 236 substances for further scrutiny by the Member State competent authorities in its annual screening exercise. The competent authorities will carry out a manual examination of dossiers they prioritise to decide whether regulatory action is needed.

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  • 23-01-2018
EDQM

Pharmeuropa Volume 30 No 1, January 2018

Users of CEPs are invited to provide comments on draft monographs published in Pharmeuropa 30.1 before 31st March 2018. 

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  • 22-01-2018
FDA - Food and Drug Administration

International Drugmakers Plan for Higher Costs as Brexit Looms

Testifying before a UK House of Commons committee last month, international pharmaceutical companies said they are already hedging their bets when it comes to the real-world consequences of Brexit, making preparations for new hurdles in manufacturing and duplications of batch release testing that could cost millions of pounds per year.

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  • 19-01-2018
ECA - European Compliance Academy

New Annex 1: Consequences for the QP

The new draft of Annex 1 (Manufacture of Sterile Medicinal Products) will be much more extensive and contain some new rules and additions. There are also some things in the Annex 1 draft QPs need to consider.

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  • 18-01-2018
UK Government

MHRA update to pharmaceutical companies on exit preparations

An update from the Medicines and Healthcare products Regulatory Agency (MHRA) to pharmaceutical companies on preparations for exiting the European Union.

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  • 17-01-2018
EMA - European Medicines Agency

Chair of EMA’s committee for orphan medicines receives award for outstanding patient engagement

Bruno Sepodes, Chair of the European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP), has received the EURORDIS European Rare Disease Leadership Award as recognition of his commitment to involve patient advocates in all discussions and decisions related to orphan medicines.

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  • 16-01-2018
EMA - European Medicines Agency

PRAC recommends suspending hydroxyethyl-starch solutions for infusion from the market

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended the suspension of the marketing authorisations for hydroxyethyl-starch (HES) solutions for infusion across the European Union. These products are used as plasma volume replacement following acute (sudden) blood loss, where treatment with alternative products known as ‘crystalloids’ alone is not considered to be sufficient.

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  • 15-01-2018
FDA - Food and Drug Administration

FDA acts to protect kids from serious risks of opioid ingredients contained in some prescription cough and cold products by revising labeling to limit pediatric use

The U.S. Food and Drug Administration announced that it is requiring safety labeling changes to limit the use of prescription opioid cough and cold medicines containing codeine or hydrocodone in children younger than 18 years old because the serious risks of these medicines outweigh their potential benefits in this population. After safety labeling changes are made, these products will no longer be indicated for use to treat cough in any pediatric population and will be labeled for use only in adults aged 18 years and older. Labeling for the medications also is being updated with additional safety information for adult use – including an expanded Boxed Warning, the FDA’s most prominent warning ‒ notifying about the risks of misuse, abuse, addiction, overdose and death, and slowed or difficult breathing that can result from exposure to codeine or hydrocodone.

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  • 12-01-2018
ECA - European Compliance Academy

GMP Update - what's new in the EU?

The GMP world was turning a bit slower in 2016 - now, it's picking up speed again. Currently, several crucial changes are being made with consequences even for national legislation.

read more >

  • 11-01-2018
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

Approval and Definition of Medicinal Products Prices – New forms

The forms for calculation of the prices of non-generic medicinal products from out-patient and hospital market, as well as of generic medicinal products, and their respective filling instructions have been updated.

read more >

  • 10-01-2018
CMDh - Co-ordination group for Mutual recognition and Decentralised procedures - Human

MSs Recommendations on Extension Applications in Mutual Recognition and Decentralised Procedures

 

read more >

  • 09-01-2018
EMA - European Medicines Agency

Human medicines highlights - January 2018

 

read more >

  • 08-01-2018
EMA - European Medicines Agency

PRAC recommendations on signals adopted at the PRAC meeting of 27-30 November 2017

 

read more >

  • 05-01-2018
FDA - Food and Drug Administration

Statement from FDA Commissioner Scott Gottlieb, M.D. on new steps to facilitate efficient generic drug review to enhance competition, promote access and lower drug prices

The FDA announced additional steps to encourage generic competition as part of the continued implementation of the Drug Competition Action Plan.

read more >

  • 04-01-2018
EDQM

Pharmeuropa: Texts for comments

Pharmeuropa issue 30.1 is now complete. Submit your comments until 31 March 2018.

read more >

  • 03-01-2018
FDA - Food and Drug Administration

FDA Clarifies Pathways for Medical Device Accessories

For the third time in under a year, the FDA issued a final guidance on medical device accessories, clarifying that a New Accessory Request can be included as part of a PMA, PMA supplement or a 510(k) submission.

read more >

  • 02-01-2018
FDA - Food and Drug Administration

FDA permits marketing of device to treat diabetic foot ulcers

Today, the U.S. FDA permitted the marketing of the Dermapace System, the first shock wave device intended to treat diabetic foot ulcers.

read more >

  • 29-12-2017
DGAV - Direção-Geral de Alimentação e Veterinária

Southern Member States update the guide concerning applications for market authorisation of phytopharmaceutical products

Working Document on the Work-sharing of the Southern Zone Member States under Regulation EC 1107/2009, revision 7.0.

read more >

  • 28-12-2017
CMDh - Co-ordination group for Mutual recognition and Decentralised procedures - Human

Extension of pilot for splitting of MRP/DCPs

Update on the "Extension of pilot for splitting of MRP/DCPs".

read more >

  • 27-12-2017
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

Annual Price Revision for the Generic Medicinal Products 2018

Binding Information Newsletter no. 171, from 22-12-2017. 

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  • 27-12-2017
PHAGECON

Annual Prices Revision 2018 - amendment

Phagecon hereby informs that Ordinance no. 359/2017, of 20 November, which proceeds with the definition of the reference countries, to be considered in 2018, for the authorisation of the prices of the new medicinal products and for purposes of annual prices revision of the hospital market and ambulatory market medicinal products, as well as it keeps, for the same year, the exceptional criterion to apply in the prices revision regimen, published in the National Official Journal, 1st series, no. 223, of 20 November 2017, has been amended

In the no. 2 of article 4, where it is read: 

«2 - From the suspension foreseen in the previous number are excluded the generic medicinal products which maximum PVP is higher than the maximum PVP of the reference medicinal product, being these subject to annual revision, in accordance with article 17 of Ordinance no. 195-C/2015, of 30 June, in its current wording.» 

it should be read: 

«2 - From the suspension foreseen in the previous number are excluded the generic medicinal products whose maximum PVP is higher than the maximum PVP of the reference medicinal products resulting from the 2018 annual revision, and those medicinal products should reduce the PVP in order not to overcome the price of the reference medicinal product.» 

We also inform that the amendment declaration was published in National Official Journal and is available at: 

https://dre.pt/web/guest/home/-/dre/114394848/details/maximized?serie=I&day=2017-12-22&date=2017-12-01
read more >

  • 22-12-2017
European Comission

Targeted stakeholders consultation on the revision of annex 1, on manufacturing of sterile medicinal products, of the Eudralex volume 4

 

read more >

  • 21-12-2017
ECA - European Compliance Academy

Now online: Draft ICH Q12

The long awaited and highly discussed ICH Q12 draft Guideline is now available online on the ICH website.

read more >

  • 20-12-2017
ECA - European Compliance Academy

New WHO Guideline for Medical Devices and IVDs

The WHO has published a finalised 76-page regulatory framework for medical devices including in vitro diagnostic medical devices (IVDs) divided into 5 chapters. 

read more >

  • 19-12-2017
EDQM

Ph.Eur. Supplement 9.5 available now

The 9.5 supplement of European Pharmacopoeia is now available and will be applicable in 38 European countries as from 01 July 2018.

read more >

  • 18-12-2017
EFPIA - European Federation of Pharmaceutical Industries and Associations

The associations representing the European and British life science industry have launched a joint policy document on the potential impact of the United Kingdom’s exit the European Union

Organisations representing the life science industry in the EU and the UK have called for medicines to be a priority in phase 2 of the Article 50 negotiations.

read more >

  • 15-12-2017
EDQM

European Pharmacopoeia Commission adopts a new monograph for Infliximab concentrated solution ‒ the first monograph on a monoclonal antibody

The European Pharmacopoeia (Ph. Eur.) Commission has achieved an important milestone in the field of biotherapeutic products at its 159th Session, held in Strasbourg on 21-22 November 2017, with the adoption of the monograph for Infliximab concentrated solution (2928).

read more >

  • 14-12-2017
FDA - Food and Drug Administration

New FDA Guidance Narrows Agency Oversight of Digital Health Products

The FDA published three new guidances on digital health products that limit the types of products the agency will regulate as medical devices.

read more >

  • 13-12-2017
EDQM

Suppression of the Test for Abnormal Toxicity from the European Pharmacopoeia

During its 159th plenary session, held in Strasbourg on 21-22 November 2017, the European Pharmacopoeia Commission endorsed the complete suppression of the test for abnormal toxicity from the European Pharmacopoeia (Ph. Eur.).

read more >

  • 11-12-2017
ECA - European Compliance Academy

Draft DIN EN ISO Injection Vials made of Tubular Glass

The DIN EN ISO committee published a draft for DIN EN ISO 8362-1 Injection vials made of glass tubing for comment.

read more >

  • 06-12-2017
CMDh - Co-ordination group for Mutual recognition and Decentralised procedures - Human

Questions and Answers related to the United Kingdom's withdrawal from the European Union with regard to national authorised medicinal products for human use

 

read more >

  • 05-12-2017
FDA - Food and Drug Administration

FDA approves first biosimilar for the treatment of certain breast and stomach cancers

The U.S. Food and Drug Administration approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene (HER2+). Ogivri is the first biosimilar approved in the U.S. for the treatment of breast cancer or stomach cancer and the second biosimilar approved in the U.S. for the treatment of cancer. 

read more >

  • 04-12-2017
ECA - European Compliance Academy

Track & Trace: New Questions and Answers published by the EU

The next version 8.0 of the catalogue containing questions and answers on practical implementation and technical aspects of serialisation requirements as per delegated act EU 2016/161 has become available on 22 November. Find more information about version 8.0 of the Q&A on EU FMD DR regarding serialisation.

read more >

  • 29-11-2017
EMA - European Medicines Agency

Guidance to help pharma companies prepare for Brexit

The European Medicines Agency (EMA) has published additional guidance to help pharmaceutical companies to prepare for United Kingdom's (UK) withdrawal from the European Union (EU).

read more >

  • 28-11-2017
UK Government

Drug Safety Update - November 2017

Monthly PDF newsletter.

read more >

  • 27-11-2017
Eur-Lex

COMMISSION IMPLEMENTING REGULATION (EU) 2017/2185 of 23 November 2017

Regulation on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices under Regulation (EU) 2017/746 of the European Parliament and of the Council.

read more >

  • 24-11-2017
EMA - European Medicines Agency

New EudraVigilance system is live

The European Medicines Agency (EMA) has launched a new and improved version of EudraVigilance, the European information system of suspected adverse reactions to medicines that are authorised or being studied in clinical trials in the European Economic Area (EEA). The new system makes it easier for marketing authorisation holders and sponsors of clinical trials to report suspected adverse reactions and allows for better analysis of this information for the benefit of patient safety in Europe.

read more >

  • 23-11-2017
ECA - European Compliance Academy

GVP Update 2017

There have been recent developments within EudraLex Volume 9 - Guidelines on good pharmacovigilance practices (GVP).

read more >

  • 22-11-2017
CMDh - Co-ordination group for Mutual recognition and Decentralised procedures - Human

CMDh Guidance on the Informal Work-Sharing procedure for follow-up for PSUSA for NAPs

Public consultation - comments should be sent to H-CMDhSecretariat@ema.europa.eu by 19 January 2018, coordinated where possible by trade associations.

read more >

  • 21-11-2017
Diário da República

Ordinance no. 359/2017 – National Official Journal no. 223/2017, Series I of 2017-11-20

Proceeds to the definition of the reference countries to be considered in 2018 for the authorization of the prices of the new medicinal products and for effects of annual prices revision of the hospital market and outpatient market medicinal products, as well as it keeps, for the same year, the exceptional criterion to be applied in the prices revision regimen.

read more >

  • 20-11-2017
ECA - European Compliance Academy

FDA's new Guidances on the Approval of Generic Drugs

The FDA has recently published various guidelines on application procedures for generics.

read more >

  • 17-11-2017
ECA - European Compliance Academy

EudraVigilance: EMA's new Signal Management Guide

In line with the go-live date of the new EudraVigilance database EMA now published the revised GVP module IX on signal management. The revised module IX will introduce major procedural changes for industry.

read more >

  • 16-11-2017
Diário da República

Order no. 9879/2017 – National Official Journal no. 220/2017, Series II of 2017-11-15

Determines the termination of the obligation of acquisition, by the entities of the National Health Service, of generics or biosimilar equivalent to those foreseen in the annexes to Orders no. 2326/2017, no. 9586/2016 and no. 10858/2015 and foreseen in the no. 2 of the referred orders, under the public procurement contracts (CPA), from the date that generic or biosimilar medicinal products reimbursed or with previous assessment decision equivalent to those foreseen in the annexes to the orders mentioned above are advertised by INFARMED - National Authority of the Medicines and Health Products.

read more >

  • 15-11-2017
EMA - European Medicines Agency

Guideline on good pharmacovigilance practices (GVP): Module VII – Periodic safety update report - Explanatory note

Adopted

read more >

  • 14-11-2017
EMA - European Medicines Agency

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 6-9 November 2017

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended ten medicines for approval, including two orphan medicines, at its November 2017 meeting.

read more >

  • 13-11-2017
ECA - European Compliance Academy

The ICH E11 Addendum on clinical investigation in children now enters into implementation

The International Council for Harmonisation, ICH, recently informed that the "E11(R1) Addendum on Clinical Investigation of Medicinal Products in the Pediatric Population reached Step 4 of the ICH Process in August 2017 and now enters into the implementation period (Step 5)". The "Addendum is proposed to address new scientific and technical knowledge advances in pediatric drug development and update the ICH E11 Guideline adopted in 2000".

read more >

  • 10-11-2017
ECA - European Compliance Academy

Data Integrity from an Inspector's Point of View

Even though the integrity of data has always been one of the basic principles of GMP, the topic has come more and more into the focus in inspections of the last 3-4 years.

read more >

  • 09-11-2017
ECA - European Compliance Academy

Positive Balance for Implementation of the Falsified Medicines Directive

The soon-to-be required safety features for the realisation of the Falsified Medicines Directive must be implemented by February 09, 2019. The German initiative securPharm strikes a positive mid-term balance.

read more >

  • 08-11-2017
FDA - Food and Drug Administration

FDA approves first treatment for certain patients with Erdheim-Chester Disease, a rare blood cancer

The U.S. Food and Drug Administration expanded the approval of Zelboraf (vemurafenib) to include the treatment of certain adult patients with Erdheim-Chester Disease (ECD), a rare cancer of the blood. Zelboraf is indicated to treat patients whose cancer cells have a specific genetic mutation known as BRAF V600. This is the first FDA-approved treatment for ECD.

read more >

  • 07-11-2017
FDA - Food and Drug Administration

FDA to Recognize GMP Inspections From Eight EU Countries

The FDA will begin to recognize manufacturing facility inspections conducted by drug regulatory authorities in Austria, Croatia, France, Italy, Malta, Spain, Sweden and the U.K as capable of meeting the agency's requirements, as part of 1998 agreement between the U.S. and the European Union renegotiated earlier this year.

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  • 06-11-2017
FDA - Food and Drug Administration

IMDRF Clarifies When Competent Authorities Can Share Confidential Information

The International Medical Device Regulators Forum released final guidance that lays out procedures for sharing confidential postmarket surveillance for medical devices among regulators.

read more >

  • 03-11-2017
EMA - European Medicines Agency

EU-FDA mutual recognition of inspections of medicines manufacturers enters operational phase

1 November 2017 marks the coming into operation of further aspects of the mutual recognition agreement between the European Union (EU) and the United States (US) to recognise inspections of manufacturing sites for human medicines conducted in their respective territories. This agreement, which updates the agreement from 1998, allows for recognition of each other's inspection outcomes and hence for better use of inspection expertise and resources.

read more >

  • 02-11-2017
FDA - Food and Drug Administration

FDA to Adopt ICH E9 Addendum on Clinical Trials Analyses

The FDA is seeking public comments on an ICH addendum to a 1998 clinical trials statistics guideline focused on the use of sensitivity analyses and targets for estimation and measurement.

read more >

  • 31-10-2017
CMDh - Co-ordination group for Mutual recognition and Decentralised procedures - Human

Position Paper concerning Applicants’ request of submission of multiple applications during ongoing DCPs or inclusion of new CMS or additional strength(s) in an already ongoing DCP

Member states have been approached by applicants requesting submission of multiple applications during ongoing DCP or inclusion of new CMS or additional strength(s) in already started DCP procedures. This position paper provides the position reached by the CMDh.

read more >

  • 30-10-2017
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

Program of Early Access to medicinal products – new regulation

Decree-Law no. 115/2017, of 7 September, which gave a new wording to article 25 of Decree-Law no. 97/2015, of 1 June, amended the conditions of exceptional use authorisation of medicinal products with marketing authorisation, establishing that, since the MA date and during the legally foreseen deadline for the previous assessment procedure, the supply of the medicinal products object of exceptional use authorisation is performed under the Early Access Program to medicinal products.

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  • 27-10-2017
EMA - European Medicines Agency

Summaries of scientific recommendations on classification of advanced therapy medicinal products

The European Medicines Agency´s Committee for Advanced Therapies delivers scientific recommendations on whether a medicine can be classified as an advanced therapy medicinal product (ATMP). The Agency publishes the outcomes of these assessements in the format of summary reports.

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  • 26-10-2017
ECA - European Compliance Academy

Specified Microorganisms - Harmonisation of the pharmacopoeial Chapters completed

The International Council for Harmonisation (ICH) finalized their recommendation relating to the use of pharmacopoeidal texts on tests for specified microorganisms.

read more >

  • 25-10-2017
EMA - European Medicines Agency

PRAC recommendations on signals adopted at the 25-29 September 2017 PRAC meeting

Adopted

read more >

  • 24-10-2017
EMA - European Medicines Agency

New action plan to foster development of advanced therapies

The European Commission's Directorate-General for Health and Food Safety (DG SANTE) and the European Medicines Agency (EMA) have published today a joint action plan to foster the development of advanced therapy medicinal products (ATMPs). The main aim is to streamline procedures and better address the specific requirements of ATMP developers.

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  • 23-10-2017
FDA - Food and Drug Administration

FDA Issues Draft Bioequivalence Guidances for 30 Drugs, Revises 17

The FDA published new product-specific draft guidances for 30 active ingredients - including cancer therapies, asthma treatments, epinephrine auto-injectors and anti-infectives - outlining the agency's preferred methods for supporting ANDA submissions.

read more >

  • 20-10-2017
FDA - Food and Drug Administration

FDA approves CAR-T cell therapy to treat adults with certain types of large B-cell lymphoma

The U.S. Food and Drug Administration approved Yescarta (axicabtagene ciloleucel), a cell-based gene therapy, to treat adult patients with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment. Yescarta, a chimeric antigen receptor (CAR) T cell therapy, is the second gene therapy approved by the FDA and the first for certain types of non-Hodgkin lymphoma (NHL).

read more >

  • 19-10-2017
ECA - European Compliance Academy

New EU GMP Guideline for IMPs

The EU Commission published two new GMP documents in the Official Journal of the European Union.

read more >

  • 18-10-2017
FDA - Food and Drug Administration

FDA Clarifies Approval Pathways for ANDA, 505(b)(2) Applications in New Draft Guidance

In new draft guidance, The FDA describes which abbreviated approval pathways are available for ANDAs and 505(b)(2) applications.

read more >

  • 17-10-2017
FDA - Food and Drug Administration

ICH Finalizes Q&A Doc on Justifying Drug Starting Materials

The ICH finalized a Q&A document clarifying its advice on the selection and justification of starting materials used in drug manufacturing.

read more >

  • 16-10-2017
EDQM

Ph. Eur. Supplement 9.4

Supplement 9.4 of the Ph. Eur. is now available. CEP holders are invited to update their applications according to the revised monographs that will be implemented on the 1st of April 2018, and to follow the instructions given in the document.

read more >

  • 13-10-2017
EDQM

EDQM and ANVISA sign Memorandum of Understanding on use of CEPs in Brazil

The European Directorate for the Quality of Medicines & HealthCare (EDQM) and ANVISA, the Health Surveillance Agency of Brazil, have signed a Memorandum of Understanding which lays the foundation for ANVISA to consider the use of Certificates of Suitability to the monographs of the European Pharmacopoeia (CEPs) for their evaluation of marketing authorisation applications (MAAs) for medicinal products.

read more >

  • 12-10-2017
ECA - European Compliance Academy

Handling of Changes to Medical Device Products for approved Combination Products

In a recent news you could read about a question-and-answer document from the EMA, describing certain issues concerning the handling of changes after approval ("variations"). This document has been updated again. The topic of changes to medical devices after the approval of "combination products" has now been added.

read more >

  • 11-10-2017
EMA - European Medicines Agency

Better labelling of excipients for safe use of medicines

The European Medicines Agency (EMA) and the European Commission have updated the annex to the European Commission guideline on excipients in the labelling and package leaflet of medicinal products for human use.

read more >

  • 10-10-2017
EMA - European Medicines Agency

Questions and Answers - ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological / biological entities)

This Question and Answer document is intended to provide additional clarification and to promote convergence and improve harmonisation of the considerations for the selection and justification of starting materials and of the information that should be provided in marketing authorisation applications and/or Master Files. The focus of the Q&A document is on chemical entity drug substances.

read more >

  • 09-10-2017
EMA - European Medicines Agency

Minutes of the CAT meeting 12-14 July 2017

 

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  • 04-10-2017
AEMPS - Agencia Española de Medicamentos y Productos Sanitarios

Changes in the presentation of translations of European and national registration procedures

Implementation of updates in the submission and loading of texts proposals with the medicinal product information and the translations for their revision during the national phase of marketing authorisation application procedures and subsequent variation procedures.

read more >

  • 03-10-2017
UK Government

Medical devices: software applications (apps)

Information on when software applications are considered to be a medical device and how they are regulated.

read more >

  • 02-10-2017
FDA - Food and Drug Administration

FDA improves access to reports of adverse drug reactions

The U.S. Food and Drug Administration launched a new user-friendly search tool that improves access to data on adverse events associated with drug and biologic products through the FDA's Adverse Event Reporting System (FAERS). The tool is designed to make it easier for consumers, providers, and researchers to access this information.

read more >

  • 29-09-2017
EMA - European Medicines Agency

Exploring opportunities for collaboration between regulators and healthcare payers

The European Medicines Agency (EMA) and European Union (EU) healthcare payers met for the first time on 19 September 2017 at EMA's offices in London to explore synergies and foster mutual understanding and cooperation to help improve timely and affordable access of patients to new medicinal products. The meeting aimed to be complementary to EMA's existing cooperation with health technology assessment (HTA) bodies and especially with EUnetHTA.

read more >

  • 28-09-2017
FDA - Food and Drug Administration

FDA Finalizes Guidance on Drug/Device Combination Product Classifications

The FDA finalized guidance on its process for assigning applications to a specific regulatory center, hoping to answer frequently asked questions from industry sponsors regarding whether their product will be classified as a drug or as a device.

read more >

  • 27-09-2017
ECA - European Compliance Academy

Qualification of Development Tools for Medical Devices - Guidance for Industry

The topic of development has been playing an important role for the FDA, not only in the pharmaceutical sector, but also with regard to medical devices for quite some time. An FDA draft guidance document on the qualification of development tools from 2013 has now been finalized.

read more >

  • 26-09-2017
EDQM

Free Webinar on CEP Revisions - Sign up today!

This webinar will outline the process for applying for revisions of CEP application files and give advice on how to obtain their fast acceptance. Learn about the revisions process, the correct classification of changes, and how to prepare and organise the documentation.

read more >

  • 25-09-2017
EDQM

LC and GC columns in monographs

With a view to improving the correspondence between liquid chromatography column brand names and the reagents used to describe the stationary phases used with these columns, an overall review of all the monographs concerned has been undertaken. The names of the reagents and their definitions have also been reviewed to ensure that these stationary phases are described as clearly and consistently as possible.

read more >

  • 22-09-2017
EDQM

Ph.Eur. Supplement 9.4 available now

The 9.4 supplement of European Pharmacopoeia is now available and will be applicable in 38 European countries as from 01 April 2018.

read more >

  • 21-09-2017
UK Government

MHRA delivers guidance on human factors

In collaboration with key stakeholders, MHRA has produced guidance on the human factors aspects of design for medical devices including those in drug-device combination products.

read more >

  • 20-09-2017
EMA - European Medicines Agency

European Medicines Agency guidance for applicants seeking scientific advice and protocol assistance

Updated guidance.

read more >

  • 19-09-2017
Eur-Lex

Commission Directive (EU) 2017/1572 of 15 September 2017 supplementing Directive 2001/83/EC of the European Parliament and of the Council as regards the principles and guidelines of good manufacturing practice for medicinal products for human use

 

read more >

  • 18-09-2017
FDA - Food and Drug Administration

FDA approves first biosimilar for the treatment of cancer

The U.S. Food and Drug Administration approved Mvasi (bevacizumab-awwb) as a biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer. Mvasi is the first biosimilar approved in the U.S. for the treatment of cancer.

read more >

  • 15-09-2017
EMA - European Medicines Agency

Update - Questions and answers: Good manufacturing practice

 

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  • 14-09-2017
ECA - European Compliance Academy

How to become a QP in Europe

Both the ECA and the European QP Association are often contacted by people who would like to become a Qualified Person in a Member State of the European Union or outside the EU to release products for the EU market. Here is what you need to know about becoming a Qualified Person.

read more >

  • 13-09-2017
Diário da República

Ordinance no. 270/2017 and Ordinance no. 271/2017 – National Official Journal no, 176/2017, Series I of 2017-09-12

Proceed to the first amendment, respectively, of:

- Ordinance no. 195-A/2015, of June 30th, which approves the common procedure of the reimbursement and previous assessment of medicinal products;

- Ordinance no. 195-B/2015, of June 30th, which regulates the determination of the homogeneous groups for purposes of the reimbursement in the reference prices system.

read more >

  • 12-09-2017
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

Infarmed Newsletter – Issue 63

Access the new edition of Infarmed Newsletter.

read more >

  • 11-09-2017
FDA - Food and Drug Administration

FDA Releases Draft Guidance on Child-Resistant Packaging

Drug companies must ensure their products meet federal standards for child-resistant packaging before labeling the packaging as child-resistant, the FDA said in draft guidance issued Aug. 2.

read more >

  • 08-09-2017
ECA - European Compliance Academy

Test for Subvisible Particles: ICH Harmonisation Completed

With Step 5, harmonisation regarding the use of pharmacopoeial methods for test for subvisible particles in the ICH regions has been completed.

read more >

  • 06-09-2017
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

Implementation of the safety devices in the human use medicinal products

The requirement to place safety devices (device of prevention of adulterations and unique identifier) in the packages of certain medicinal products in order to allow the detection of falsified medicinal products in the legal circuit of the medicinal product and the individual identification of packages was introduced by Ordinance 2011/62/UE, Ordinance of the Falsified Medicinal Products and has to be implemented until 09 February 2019.

read more >

  • 05-09-2017
EMA - European Medicines Agency

Facilitating submission of post-approval data

The European Medicines Agency has launched a new form to help marketing authorisation holders submit data generated to satisfy post-authorisation measures (PAMs) for centrally authorised products.

read more >

  • 04-09-2017
EMA - European Medicines Agency

Draft ICH S5 (R3) guideline on reproductive toxicology: detection of toxicity to reproduction for human pharmaceuticals, step 2b - Revision 3

Draft: consultation open

read more >

  • 01-09-2017
ECA - European Compliance Academy

ICH Q4B - Harmonisation relating to the Sterility Test - General Chapters completed

The International Council for Harmonisation ICH Q4B - Harmonisation of pharmacopoeial chapters on Sterility Test with step 5 has now been finalized

read more >

  • 31-08-2017
UK Government

Medical devices: EU regulations for MDR and IVDR

What you need to know about the new EU Regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR).

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  • 30-08-2017
FDA - Food and Drug Administration

FDA Draws Up Blueprint for Pre-Approval Facility Reviews

The FDA has outlined plans for coordination between CDER and ORA in checking out the manufacturing facilities of drugmakers seeking approval for new pharmaceuticals.

read more >

  • 29-08-2017
UK Government

Apply for manufacturer or wholesaler of medicines licences

How to apply for, update and cancel licences for the manufacture, import and wholesale of human and veterinary medicines.

read more >

  • 28-08-2017
ECA - European Compliance Academy

Revised Ph. Eur. Chapter Tablets

Recently, the revised PH. Eur. Monograph Tablets (0478) has been published in Ph. Eur. Supplement 9.3.

read more >

  • 25-08-2017
EMA - European Medicines Agency

Strengthening EU-US cooperation in medicine inspections

The European Commission (EC), the United States (US) Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have signed a new confidentiality commitment that allows the Us regulator to share non-public and commercially confidential information, including trade secret information relating to medicine inspections with EU regulators. This confidentiality commitment is a milestone in the ongoing implementation of the mutual recognition of inspections of medicine manufacturers and it aims to strengthen the EU-US relationship. Ultimately it will contribute to a more efficient use of inspection resources by regulators for the protection of human and animal health.

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  • 24-08-2017
ECA - European Compliance Academy

News questions and answers about safety features - Version 7 of the EU Q&As published

The soon-to-be mandatory safety features for the implementation of the Falsified Medicines Directive have to be implemented by February 9th, 2019. The European Commission has published Version 7 of the questions and answers about safety features in June 2017.

read more >

  • 23-08-2017
FDA - Food and Drug Administration

FDA’s Expedited Programs Predict Better Drugs, But Companies Are Still Slow to Confirm Benefits, Researchers Say

The FDA has largely succeeded in expediting the review of drugs with larger health gains, but postmarket trials by companies have fallen behind in confirming some of those benefits, with many not using the gold standard of randomized controlled trials, according to two independent studies.

read more >

  • 22-08-2017
EMA - European Medicines Agency

Guideline on manufacture of the finished dosage form

Revision 1, adopted

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  • 21-08-2017
EMA - European Medicines Agency

Monthly report on application procedures guidelines and related documents for veterinary medicines: July 2017

This report, which is updated every month, provides current information related to the volume and evaluation of pre and post-authorisation applications for medicinal products for veterinary use received by the European Medicines Agency.

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  • 11-08-2017
EMA - European Medicines Agency

What's new in pharmacovigilance - QPPV Update - Issue 2 - 2017

Information on recent developments in EU Pharmacovigilance, relating to medicines for human use, and includes updates on the EU network activities and relevant projects.

read more >

  • 10-08-2017
EMA - European Medicines Agency

Annual report of the Pharmacovigilance Inspectors Working Group for 2016

This document is the ninth annual report of the Pharmacovigilance Inspectors Working Group.

read more >

  • 09-08-2017
EMA - European Medicines Agency

New product information wording: extracts from PRAC recommendations on signals adopted at the 3-6 July 2017 PRAC

The product information wording in this document is extracted from the document entitled "PRAC recommendations on signals" which contains the whole text of the PRAC recommendations for product information update, as well as some general guidance on the handling of signals.

read more >

  • 08-08-2017
CMDh - Co-ordination group for Mutual recognition and Decentralised procedures - Human

Update - CMDh Best Practice Guide on the use of eCTD in the MRP/DCP

Track version.

read more >

  • 07-08-2017
EFSA - European Food Safety Authority

Transparency and data quality: new cross-cutting EFSA guidance in a nutshell

Two new guidance documents - on the weight-of-evidence approach and biological relevance assessment - will help to further harmonise methodologies across the areas in which EFSA works.

read more >

  • 04-08-2017
EMA - European Medicines Agency

Questions and answers on production of water for injections by non-distillation methods – reverse osmosis and biofilms and control strategies

 

read more >

  • 03-08-2017
ECA - European Compliance Academy

USP monograph <1790>

The long-awaited new monograph <1790> of the US Pharmacopoeia about the visual inspection of injections, which is supposed to be an explanation for the already valid chapter <790>, will finally come into force on August, 1st.

read more >

  • 02-08-2017
ECHA

IUCLID Cloud launched – simpler for smaller companies

The cloud version of the chemical data management tool IUCLID is now available for SMEs. Consultants helping SMEs with their registrations are welcome to subscribe too. In the cloud, you can prepare your REACH registration dossier directly online so there is no need for local installation. Reap the benefits of the cloud: data stored and safe at ECHA, automatic updates of IUCLID, fully managed back-ups, 24/7 availability of service.

read more >

  • 01-08-2017
CMDh - Co-ordination group for Mutual recognition and Decentralised procedures - Human

Q&As on impact of EU-USA mutual recognition agreement on marketing authorisation applications and relevant variations

 

read more >

  • 31-07-2017
EMA - European Medicines Agency

Small and Medium-sized Enterprises Office Newsletter - Issue 40

 

read more >

  • 28-07-2017
ECA - European Compliance Academy

API starting materials: EMA publishes updated reflection paper

In the recently published updated EMA reflection paper about starting materials, the passage about description of the manufacturing process of an API in an authorisation dossier has been revised.

read more >

  • 27-07-2017
EMA - European Medicines Agency

Revised guideline on first-in-human clinical trials

The European Medicines Agency (EMA) has revised its guidance on first-in-human clinical trials to further help stakeholders identify and mitigate risks for trial partcipants.

read more >

  • 26-07-2017
EMA - European Medicines Agency

Reflection paper on promotion of pharmacovigilance reporting

Adopted

read more >

  • 25-07-2017
EMA - European Medicines Agency

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 July 2017

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended eleven medicines for approval at its July meeting.

read more >

  • 24-07-2017
EDQM

Ph. Eur. Supplement 9.3

Supplement 9.3 of the Ph. Eur. is now available. CEP holders are invited to update their applications according to the revised monographs that will be implemented on the 1st of January 2018, and to follow the instructions given in the document HERE.

read more >

  • 21-07-2017
EMA - European Medicines Agency

Mutual recognition agreements

The European Union (EU) has signed mutual recognition agreements (MRAs) with third-country authorities concerning the conformity assessment of regulated products. Such agreements contain a sectoral annex on the mutual recognition of good manufacturing practice (GMP) inspections and batch certification of human and veterinary medicines.

read more >

  • 20-07-2017
ECA - European Compliance Academy

EMA's updated Implementation Plan for the Introduction of Safety Features

The soon-to-be required safety features for the execution of the Falsified Medicines Directive have to be implemented by February 9th, 2019. The EMA has published an updated plan for the implementation of safety features on the packaging of centrally authorized products for human use.

read more >

  • 19-07-2017
Diário da República

Order no. 6289/2017 - National Official Journal no. 137/2017, Series II of 2017-07-18

Amends no. 4 of Order no. 5657/2017, published in National Official Journal, 2nd series, no. 123, of 28 June (clarifies the scope of application and establishes a quick and transparent procedure regarding the authorization applications underlying the provisions of article 9 of Decree-Law no. 5/2017, of 6 January).

read more >

  • 18-07-2017
EMA - European Medicines Agency

Regulatory information – EMA improves its guidance for post-authorisation activities

The European Medicines Agency (EMA) has updated its best practice guidelines and support documents for marketing authorisation holders (MAHs) in the areas of type II variations, post-authorisation safety studies and changes related to quality aspects.

read more >

  • 17-07-2017
EMA - European Medicines Agency

Questions and answers of scientific guideline

Improving the understanding of normal operating range (NOR), proven acceptable range (PAR), design space (DSp) and normal variability of process parameters. read more >

  • 14-07-2017
ECA - European Compliance Academy

What is GMP compliant Equipment Design?

It's frequent question what GMP compliant equipment design is or how a system has to be made up in order to be GMP compliant and suitable for the manufacturing of medicinal products/APIs. There is a short and a long answer to these questions around GMP compliant equipment design.

read more >

  • 13-07-2017
EMA - European Medicines Agency

European Union individual case safety report (ICSR) implementation guide

This guidance specifies the technical requirements and the process of transmission of Individual Case Safety Reports (ICSRs) and is applicable to all stakeholders, which are exchanging ICSRs electronically within the EEA.

read more >

  • 12-07-2017
EFSA - European Food Safety Authority

New tools to potentially reduce need for animal testing

EFSA recently launched its OpenFoodTox database of chemical hazards in food and feed. The database is a rich source of toxicological information for risk assessment that can potentially support the reduction of animal testing.

read more >

  • 11-07-2017
EMA - European Medicines Agency

The launch of the new EudraVigilance system

This document addresses questions received from stakeholders in preparation of the launch of the new EudraVigilance System, which is to go-live on 22 November 2017.

read more >

  • 10-07-2017
EMA - European Medicines Agency

Data on medicines (ISO IDMP standards)

The European Medicines Agency (EMA) is in the process of implementing the standards developed by the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP).

read more >

  • 07-07-2017
European Comission

Targeted stakeholder consultation on the experience acquired with the Paediatric Regulation

Results of the public consultation on the Paediatric Regulation are now available.

read more >

  • 06-07-2017
EMA - European Medicines Agency

EMA and EUnetHTA step up interaction to align data requirements

The European Medicines Agency (EMA) and the European Network for Health Technology Assessment (EUnetHTA) are stepping up their efforts to provide developers of medicines with simultaneous, coordinated advice on their development plans and facilitate alignment of data requirements.

read more >

  • 05-07-2017
EDQM

Pharmeuropa: Texts for comments

Pharmeuropa issue 29.3 is now complete. Submit your comments before 30 September 2017.

read more >

  • 04-07-2017
EMA - European Medicines Agency

Pre-submission checklist for type II variation applications

The Agency strongly recommends that this checklist is used in advance of submission of type II variation applications. You should be able to answer "Yes" to every item listed below unless a specific point is not applicable ("n/a") to the application in question. Please note that this checklist should not be included in the submission.

read more >

  • 03-07-2017
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

Decree-Law no. 5/2017, of 6 January – article 9 Establishments, Services and Bodies of the NHS and of the Ministry of Health and Communications Platform – Transparency and Advertising

Decree-Law no. 5/2017, of 6 January, which approves the general principles of advertising to medicinal products and medical devices, establishes specific rules regarding the scientific actions to be performed in establishments, services and bodies of the National Health System (NHS) and of the Ministry of Health (MH) and to the reception of support and benefits from these entities, as well as it also does some changes in the regimen of obligations of communications foreseen in article 159 of the Portuguese Medicinal Products Statute, approved by Decree-Law no. 176/2006, of 30 August, and in article 52 in Decree-Law no. 145/2009, of 17 June, recently become effective.

read more >

  • 30-06-2017
EDQM

The MEDICRIME Convention in a few words

The EDQM plays a major role in implementing and monitoring the Council of Europe Convention on falsified medical products and similar crimes involving threats to public health, known as the MEDICRIME Convention.

read more >

  • 29-06-2017
EDQM

EDQM publishes its 2016 Annual Report

The EDQM has just published its 2016 Annual Report. The report is an opportunity to review the different activities of the past year and reflect on what the EDQM accomplished and developed. In her foreword, EDQM Director, Dr Susanne Keitel, comments on the year's events, achievements, and thanks all involved for their dedication, expertise and support.

read more >

  • 28-06-2017
EMA - European Medicines Agency

The user manual of EudraVigilance Web reporting tool EVWEB (version 1.0) is now available

  read more >

  • 27-06-2017
EMA - European Medicines Agency

Two new medicines recommended for the treatment of chronic hepatitis C

The European Medicines Agency has recommended granting marketing authorisations in the European Union (EU) for Maviret and Vosevi, two new medicines indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults.

read more >

  • 26-06-2017
FDA - Food and Drug Administration

FDA Pediatric Cancer Panel Suggests More International Research Collaboration

In the second day of a two-day meeting, an FDA pediatric cancer advisory panel suggested further international cooperation and emphasized the need for tailoring trials to their specific diseases, while recommending against the use of placebos in pediatric cancer drug trials.

read more >

  • 23-06-2017
ICH

ICH M7(R1) Addendum reaches Step 4 of the ICH Process

The ICH M7(R1) Addendum reached Step 4 of the ICH process in May 2017 and now enters into the implementation period (Step 5).

read more >

  • 22-06-2017
European Comission

Implementation of the Falsified Medicines Directive

Version 7 of "Questions and Answers" document regarding the implementation of the rules on the safety features for medicinal products for human use is now available.

read more >

  • 21-06-2017
CMDh - Co-ordination group for Mutual recognition and Decentralised procedures - Human

Pharmacovigilance Legislation

The Q&A on the Pharmacovigilance legislation have been updated. Please find it in the track version of the document in force.

read more >

  • 20-06-2017
EMA - European Medicines Agency

European Medicines Agency’s interaction with industry stakeholders - Annual report 2016

 

read more >

  • 19-06-2017
CMDh - Co-ordination group for Mutual recognition and Decentralised procedures - Human

Examples for acceptable and not acceptable groupings for MRP/DCP products

 

read more >

  • 09-06-2017
European Comission

SCCS - Request for a scientific opinion

Submission II on the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products.

read more >

  • 08-06-2017
EFSA - European Food Safety Authority

Applications pilot: dedicated support for small and medium-sized enterprises

EFSA has launched a new support initiative for applicants from small and medium-sized enterprises (SMEs). In the next six month, SMEs in the areas of feed additives and novel foods (excluding traditional food) can request an administrative check of their draft dossiers prior to submission. The support will be provided via teleconferences.

read more >

  • 07-06-2017
ECHA

REACH tests need to comply with good laboratory practice

ECHA reminds registrants that all toxicological and ecotoxicology tests need to be carried out in compliance with good laboratory practice (GLP).

read more >

  • 06-06-2017
EDQM

Communicating Chemical Hazards Related to Reference Standards

Update.

read more >

  • 05-06-2017
EMA - European Medicines Agency

Concept paper on the need for the development of a reflection paper on regulatory requirements for the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH)

Draft: consultation open

read more >

  • 02-06-2017
EMA - European Medicines Agency

Regulatory guidance for industry to prepare for the UK’s withdrawal from the EU

The European Medicines Agency (EMA) and the European have published guidance to help pharmaceutical companies to prepare for the United Kingdom´s withdrawal from the European Union. The guidance relates to both human and veterinary medicines.

read more >

  • 01-06-2017
ECHA

Substance not in the review programme? Check if you can still use it

A list of those active substances not covered by the review programme that can continue to be used in biocidal products is now available.

read more >

  • 31-05-2017
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

Simplex + 2016 Program

Infarmed has implemented 9 measures within the scope of the Simplex + 2016 Program.

read more >

  • 30-05-2017
FDA - Food and Drug Administration

Drugmakers Seek Clarifications of FDA’s Interchangeability Guidance

More drugmakers have weighed in on the FDA´s draft guidance on biosimilar interchangeability, urging the agency to make clear the designation does not mean a product is superior in terms of safety or efficacy. read more >

  • 29-05-2017
UK Government

Medicines: apply for a parallel import licence

How to get a parallel import licence for your medicine in the UK, including pharmacovigilance requirements and submitting your application.

read more >

  • 26-05-2017
UK Government

Decide if your product is a medicine or a medical device

How the Medicines and Healthcare products Regulatory Agency (MHRA) makes decisions on what is a medicine or medical device (borderline products).

read more >

  • 25-05-2017
EDQM

European Pharmacopoeia: supplements 9.1 to 9.5 and new downloadable version available to order

Supplements 9.1 to 9.5 of the European Pharmacopoeia are now available to order on the EDQM store. These supplements, which are expected to be ready for dispatch during June, contain all the regulatory information that will come into force in the course of 2018. They complement the 9th Edition launched last year and bring the total number of monographs to 2351 (including dosage forms), along with 361 general texts (including general monographs and methods of analysis) and around 2670 descriptions of reagents.

read more >

  • 24-05-2017
EMA - European Medicines Agency

EudraVigilance

EMA will launch a new EudraVigilance system with enhanced functionalities for reporting and analysing suspected adverse reactions in November 2017.

read more >

  • 23-05-2017
EMA - European Medicines Agency

Chemistry of active substances (chemistry of new active substances)

This document describes the type of information required for the manufacture and control of active substances (existing or new chemical entities) used in a medicinal product. Effective from 21/05/2017.

read more >

  • 22-05-2017
ECHA

May Newsletter published

In the May issue of the ECHA Newsletter, you can read expert views on how close we are to end animal testing, how safe artificial pitches are and how you can now find safer chemicals online.

read more >

  • 19-05-2017
EMA - European Medicines Agency

EudraVigilance Data Analysis System (EVDAS)

User registration steps for EU QPPVs or trusted deputies (for the purpose of the EudraVigilance registration process).

read more >

  • 18-05-2017
EMA - European Medicines Agency

European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes

This guidance document addresses a number of questions which marketing authorisation holders (MAHs) may have on post-authorisation procedures. It provides an overview of the Agency´s position on issues, which are typically addressed in discussions or meetings with MAHs in the post-authorisation phase. 

read more >

  • 17-05-2017
European Comission

Report of the consultation - Public consultation on strengthening EU cooperation on Health Technology Assessment (HTA)

 

read more >

  • 16-05-2017
Diário da República

Ordinance no. 111/2017 - National Official Journal No. 93/2017, Series II of 2017-05-15

Adds the annex to Ordinance no. 158/2014, of 21 February, which reviews the special reimbursement regimen for medicinal products meant for the treatment of the hepatitis C disease, adding the medicinal product containing the substance Sofosbuvir + Velpatasvir.

read more >

  • 15-05-2017
EMA - European Medicines Agency

Minutes of the PDCO meeting on 21-24 March 2017

 

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  • 12-05-2017
EMA - European Medicines Agency

Progress on science, medicines and health

The European Medicines Agency's (EMA) 2016 annual report focuses on the Agency's key achievements in the areas of medicine evaluation, support to research and development of new and innovative treatments and the safety monitoring of medicines in real life.

read more >

  • 11-05-2017
ECA - European Compliance Academy

Nitrogen Use in pharmaceutical Production

Nitrogen often comes in contact with a product during manufacturing and is therefore relevant for its quality, especially when it comes to the manufacture of sterile products. Nonetheless, the use of nitrogen is significantly less specified than that of pharmaceutical water. Parameters and limits have to be defined by the pharmaceutical users themselves.

read more >

  • 10-05-2017
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

Press Release – Ministers of six countries sign unprecedented agreement for access to medicinal products

The Ministers of Health of six European countries, including the Minister of Health Adalberto Campos Fernandes, signed yesterday the La Valletta Declaration, an unprecedented agreement that aims to ensure patient access to innovative medicinal products and, at the same time, the sustainability of the healthcare systems.

read more >

  • 09-05-2017
EMA - European Medicines Agency

Biosimilars in the EU - Information guide for healthcare professionals

 

read more >

  • 08-05-2017
Eur-Lex

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices

Amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.

read more >

  • 05-05-2017
CMDh - Co-ordination group for Mutual recognition and Decentralised procedures - Human

Generics

CMDh questions & answers - update.

read more >

  • 04-05-2017
ECA - European Compliance Academy

Now Official: Revised USP Plastic Packaging Chapters <661.1> and <661.2>

The USP Expert Committee General Chapters - Packaging and Distribution posted on April 28, 2017, the previously announced Revision Bulletins, Postponement, regarding general chapters <659>, <661>, <661.1> and <661.2>. The revisions of the four general chapters have become official on May 1, 2017.

read more >

  • 03-05-2017
EMA - European Medicines Agency

Draft Addendum of the ‘ICH E11(R1) guideline on clinical investigation of medicinal products in the paediatric population’ (EMA/CPMP/ICH/2711/1999)

Overview of comments received by the European Medicines Agency

read more >

  • 02-05-2017
CMDh - Co-ordination group for Mutual recognition and Decentralised procedures - Human

February 2017 CMDh Minutes

 

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  • 28-04-2017
EMA - European Medicines Agency

Quality of medicines questions and answers: Part 2

Update.

read more >

  • 27-04-2017
UK Government

Drug Safety Update: monthly newsletter

Monthly PDF editions of the Drug Safety Update newsletter from MHRA and its independent advisor the Commission on Human Medicines.

read more >

  • 26-04-2017
EMA - European Medicines Agency

Minutes of the CVMP meeting of 14-16 March 2017

 

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  • 21-04-2017
EMA - European Medicines Agency

Final CHMP work plan 2017

Adopted by the Committee on 23 February 2017.

read more >

  • 20-04-2017
AEMPS - Agencia Española de Medicamentos y Productos Sanitarios

Instruction document of the Spanish Agency for Medicinal Products and Medical Devices for conducting clinical trials in Spain

In this instruction document of the Spanish Agency of Medicinal Products and Medical Devices for conducting clinical trials in Spain is provided, in a questions and answers format, information on the practical aspects that entail the application of the Royal Decree 1090/2015, of 4 December, highlighting the differences concerning the previous royal decree. 

read more >

  • 19-04-2017
EMA - European Medicines Agency

Minutes of the CHMP meeting 20-23 February 2017

 

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  • 18-04-2017
CEIC - Comissão de Ética para a Investigação Clínica

PUBLISHING OF THE GLOBAL STATISTIC DATA OF THE YEAR 2016 (RESULTS ON 31/12/2016)

The global statistic data of the year 2016 (results on 31/12/2016) are published, available in the spacer Indicators CEIC. The indicators regarding Clinical Trials with Medicinal Products, Clinical Trials with Intervention of Medical Devices and Financial Contracts of Studies approved by CEIC are available.

read more >

  • 17-04-2017
EMA - European Medicines Agency

Draft guideline on good clinical practice compliance in relation to trial master file (paper and/or electronic) for content, management, archiving, audit and inspection of clinical trials

Draft: consultation open

read more >

  • 13-04-2017
EMA - European Medicines Agency

What's new in Pharmacovigilance - QPPV Update - Issue 1 - 2017

This is the first issue of QPPV Update in 2017. It provides Qualified Persons responsible for Pharmacovigilance (QPPVs) and all other people working in pharmacovigilance with an update on EU Pharmacovigilance.

read more >

  • 12-04-2017
Eur-Lex

Position (EU) No 2/2017 of the Council at first reading

Adoption of a Regulation of the European Parliament and of the Council on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

read more >

  • 11-04-2017
FDA - Food and Drug Administration

FDA approves two hepatitis C drugs for pediatric patients

The U.S. Food and Drug Administration approved supplemental applications for Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) to treat hepatitis C virus (HCV) in children ages 12 to 17. Harvoni and Solvaldi were previously approved to treat HCV in adults.

read more >

  • 10-04-2017
EMA - European Medicines Agency

Optimising safety information for medicines in Europe throughout product lifecycle

Following two years of experience with safety monitoring of nationally authorised medicines via the single assessment of periodic safety update reports (PSURs), the European Medicines Agency (EMA) has issued additional guidance and recommendations as part of its commitment to continuous process improvement.

read more >

  • 07-04-2017
ECA - European Compliance Academy

EMA revises Guide on Pharmaceutical Water

According to the European Pharmacopoeia, it is allowed as of the 1st of April 2017 to produce water for injection (WFI) using cold i.e. non-distillation methods. Now, the European Medicines Agency EMA has published a concept paper on the revision of the "Note for Guidance on Quality of water for pharmaceutical use".

read more >

  • 06-04-2017
EMA - European Medicines Agency

PRAC recommendations on signals adopted at the PRAC meeting of 6-9 March 2017

Adopted

read more >

  • 05-04-2017
CMDh - Co-ordination group for Mutual recognition and Decentralised procedures - Human

CMDh Best Practice Guidance on collaboration between Member States in relation to serious GMP non-compliance issues

The aim of this Best Practice guide is to facilitate the collaboration among MSs in the Coordination Group for Mutual Recognition and Decentralised Procedure (human), CMDh, on serious GMP issues notified to the group.

read more >

  • 04-04-2017
EMA - European Medicines Agency

Clinical development of fixed combination medicinal products

Adopted guideline

read more >

  • 03-04-2017
EMA - European Medicines Agency

Good pharmacovigilance practices

Good pharmacovigilance practices (GVP) are a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (EU). GVP apply to marketing-authorisation holders, the European Medicines Agency and medicines regulatory authorities in EU Member States. They cover medicines authorised centrally via the Agency as well as medicines authorised at national level.

read more >

  • 31-03-2017
CMDh - Co-ordination group for Mutual recognition and Decentralised procedures - Human

CMDh procedural advice on changing the RMS

In exceptional circunstances, a Marketing Authorisation Holder (MAH) may request a change of the Reference Member State (RMS).

read more >

  • 30-03-2017
ECA - European Compliance Academy

EMA Q&A on GCP

The European Medicines Agency (EMA) recently published Questions and Answers on good clinical practice (GCP) on its website.

read more >

  • 29-03-2017
EMA - European Medicines Agency

Scientific guidelines with summary-of-product-characteristics recommendations

Update

read more >

  • 28-03-2017
Eur-Lex

COMMISSION IMPLEMENTING REGULATION (EU) 2017/556, of 24 March 2017, on the detailed arrangements for the good clinical practice inspection procedures pursuant to Regulation (EU) No 536/2014 of the European Parliament and of the Council

Text with EEA relevance

read more >

  • 27-03-2017
EMA - European Medicines Agency

Use of big data to improve human and animal health

Together with the heads of the national competent authorities in the European Economic Area (EEA), known as Heads of Medicines Agencies (HMA), the European Medicines Agency (EMA) has established a new task force to explore how medicines regulators in the EEA can use big data to support research, innovation and robust medicines development in order to benefit human and animal health.

read more >

  • 24-03-2017
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

New portal “Information System for the Assessment of the Health Technologies – SIATS”

As from today, 23rd March, the new SIATS (Information System for the Assessment of the Health Technologies) portal is available, which will allow the MA holders and their representatives to manage the medicinal products accessibility.

read more >

  • 23-03-2017
ECA - European Compliance Academy

Annex 16 QP Certification: important Questions and Answers

What can a Supply Chain Diagram look like? How to rely on vendor-supplied samples? These are just two examples of questions being frequently asked in connection with the new Annex 16 of the EU-GMP Guidelines (Certification by a Qualified Person and Batch Release).

read more >

  • 22-03-2017
EMA - European Medicines Agency

Agenda - CHMP agenda of the 20-23 March 2017

Draft agenda for the meeting on 20-23 March 2017

read more >

  • 21-03-2017
EMA - European Medicines Agency

2016 annual report on EudraVigilance for the European Parliament, the Council and the Commission

This Annual report is prepared in accordance with EU legislation and summarises the EudraVigilance related activities performed in 2016.

read more >

  • 20-03-2017
EMA - European Medicines Agency

Quality of medicines questions and answers: Part 1

These questions and answers address a number of questions that have been brought to the attention of the Joint Committee for Medicinal Products for Human Use / Committee for Medicinal Products for Veterinary Use Quality Working Party (QWP) by marketing-authorisation holders (MAHs) or European Economic Area (EEA) competent authorities, on matters related to the quality of medicines. They have been developed and are maintained by the QWP.

read more >

  • 17-03-2017
EMA - European Medicines Agency

Launch of SPOR data management services

The European Medicines Agency (EMA) is preparing data management services in the four domains of master data in pharmaceutical regulatory processes: substance, product, organisation and referential (SPOR) data. The SPOR services will support the implementation of the standards developed by the International Organization for Standardization (ISO) for the identification for medicinal products (IDMP).

read more >

  • 16-03-2017
ECA - European Compliance Academy

EMA Paper on Dissolution Specification for Generic Products published

The EMA published the draft of the "Reflection paper on the dissolution specification for generic oral immediate release products".

read more >

  • 15-03-2017
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

Variations to the terms of MA: National Procedure

Frequently Asked Questions - National Variations

read more >

  • 14-03-2017
EMA - European Medicines Agency

Regulatory cooperation to improve global health

How to improve the availability of high quality, safe and effective medicines to patients in countries beyond Europe and how to make better use of existing tools? These were two of the questions discussed at a workshop jointly organised by the European Medicines Agency (EMA) and the Maltese Presidency of the European Union (EU) that brought together regulators from across the EU and Africa in Malta on 2 and 3 March 2017.

read more >

  • 13-03-2017
FDA - Food and Drug Administration

EC Report Recommends Policy Actions on Off-Label Use

Regulations on off-label use are not harmonized across the European Union - only 10 out of 21 surveyed member states have specific policies, according to a European Commission report

read more >

  • 10-03-2017
EMA - European Medicines Agency

Implementation strategy of ICH Q3D guideline

The purpose of this document is to address specific considerations to enable the practical implementation of ICH Q3D Guideline for Elemental Impurities in the European Union.

read more >

  • 09-03-2017
ECA - European Compliance Academy

Sterile plastic containers for human blood and blood components

A draft of Ph. Eur. chapter 3.2.3 Sterile plastic containers for human blood and blood components has been published for comments in Pharmeuropa 29.2. Deadline for comments is June 30, 2017.

read more >

  • 08-03-2017
EMA - European Medicines Agency

Concept paper on the need for revision of note for guidance on quality of water for pharmaceutical use (H+V)

Draft: consultation open

read more >

  • 07-03-2017
CEIC - Comissão de Ética para a Investigação Clínica

CEIC Guideline on the SUPPLY OF THE MEDICAL DEVICE IN THE SCOPE OF CLINICAL STUDIES WITH INTERVENTION

In the CEIC website, in the spacer Guidelines the CEIC Guideline on the SUPPLY OF THE MEDICAL DEVICE IN THE SCOPE OF CLINICAL STUDIES WITH INTERVENTION is published. This document was approved in plenary meeting on 20th February and published on 24th February.

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  • 06-03-2017
EMA - European Medicines Agency

Mutual recognition with the United States

Authorities in the European Union (EU) and the United States (US) have put in place a mutual recognition agreement (MRA) on good manufacturing practice (GMP) inspections. The aim of the agreement is to encourage greater international harmonisation, make better use of inspection capacity and reduce duplication.

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  • 03-03-2017
EMA - European Medicines Agency

PRIME: priority medicines

PRIME is a scheme launched by the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need. This voluntary scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimise development plans and speed up evaluation so these medicines can reach patients earlier.

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  • 02-03-2017
ECA - European Compliance Academy

Delegate Regulation on the Anti-Counterfeiting Directive

New EU Requirements and State of Implementation

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  • 01-03-2017
EMA - European Medicines Agency

Adaptive Pathways

Report on a meeting with stakeholders held at EMA on Thursday 8 December 2016.

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  • 24-02-2017
CMDh - Co-ordination group for Mutual recognition and Decentralised procedures - Human

Best Practice Guide on the Assessment Report for Mutual Recognition and Decentralised Procedures

Update

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  • 23-02-2017
EDQM

New downloadable version of the European Pharmacopoeia

With the publication of Supplement 9.3 the USB version of Ph.Eur. will be replaced by a downloadable version.

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  • 22-02-2017
ICH

The ICH Q11 draft Q&A presentation available now on the ICH website

The ICH Q11 Questions and Answers (Q&As) on the Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities), regarding the selection and justification of starting materials, reached Step 2b of the ICH Process in November 2016 and now enters the consultation period. A training presentation has also been developed by the expert Working Group.

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  • 21-02-2017
EMA - European Medicines Agency

Questions and answers: Good manufacturing practice

European Medicines Agency´s answers to frequently asked questions, as discussed and agreed by the Good Manufacturing Practice (GMP) / Good Distribution Practice (GDP) Inspectors Working Group (Update).

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  • 20-02-2017
EMA - European Medicines Agency

Concept paper on developing a guideline on quality requirements of medicinal products containing a device component for delivery or use of the medicinal product

Draft: consultation open

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  • 17-02-2017
EDQM

EDQM on biosimilars: Ph. Eur. monographs are flexible and evolving standards

During a seminar coorganised with the European Medicines Agency (EMA), the EDQM clarified further the role that Ph. Eur. monographs play in the assessment of biosimilars. As public standards for the quality of medicines in Europe, monographs ensure the quality of biosimilar and other biotherapeutic products, but compliance with them is not sufficient for demonstrating biosimilarity. However, while Ph. Eur. monographs provide specifications in the form of tests and acceptance criteria for all medicines, they are dynamic documents that can be adapted to scientific progress.

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  • 16-02-2017
Diário da República

Ordinance no. 1542/2017 – National Official Journal no. 33/2017, Series II of 2017-02-15

Defines the concept of "insignificant valuables and relevant for the practice of the healthcare professional " providing its uniform fixation, in the scope of the sectors of the medicinal product and of the medical devices.

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  • 15-02-2017
EDQM

Revised document published on Management of applications for new CEPs and revisions/renewals of CEPs.

The document PA/PH/CEP (13) 110 which described the policy for assessment of CEP applications has been revised following a review of current practice.

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  • 14-02-2017
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

Press Release – Europe begins safety assessment of quinolones (antibiotics)

The European Medicines Agency (EMA) began the safety review of the quinolones and fluoroquinolones, which are broad spectrum antibiotics used in the treatment of severe bacterial infections. The purpose of this review - which originated a newsletter published at Infarmed´s website - is to assess the duration of severe adverse reactions that affect the muscles, the joints and the nervous system.

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  • 13-02-2017
UK Government

New MedRegs blog

MHRA has launched an official blog providing expert insight into the latest regulatory thinking and all aspects of medicines regulation.

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  • 10-02-2017
EMA - European Medicines Agency

Annual report on the use of the special contribution for orphan medicinal products

Patients suffering from rare diseases deserve access to the same quality of medicinal products as other patients within the European Union (EU). The incentives laid down in the orphan legislation aim to simulate sponsors to develop medicinal products for rare diseases. Medicinal products eligible for incentives are identified throught the EU procedure of orphan designation. The orphan designations cover a wide variety of rare diseases, including genetic diseases and rare cancers, for which there are limited treatment options, a large number of these diseases also affect children.

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  • 09-02-2017
EMA - European Medicines Agency

Support for applications on Article 58

EMA has in place a range of regulatory tools to support applicants in the development and submission of applications for medicinal products relevant to Article 58.

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  • 08-02-2017
EMA - European Medicines Agency

Agenda - Pharmacovigilance Risk Assessment Committee (PRAC)

Draft agenda for the meeting on 6-9 February 2017

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  • 07-02-2017
EMA - European Medicines Agency

Guideline on core SmPC and Package Leaflet for nanocolloidal technetium (99mTc) albumin - First version

Adopted

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  • 06-02-2017
EMA - European Medicines Agency

Summaries of scientific recommendations on classification of advanced therapy medicinal products

The European Medicines Agency´s Committee for Advanced Therapies delivers scientific recommendations on whether a medicine can be classified as an advanced therapy medicinal product (ATMP). The Agency publishes the outcomes of these assessements in the format of summary reports.

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  • 03-02-2017
EMA - European Medicines Agency

Clinical data for two more medicines now available online

The European Medicines Agency (EMA) has published clinical data for two additional medicines on its clinical data website. This follows the launch of the website on 20 October 2016 and is in line with the Agency's policy on the publication of clinical data.

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  • 02-02-2017
ECA - European Compliance Academy

Elemental Impurities: The Next Steps for the Implementation of ICH Q3D into the European Pharmacopoeia

The EDQM has published the next steps for the implementation of the ICH Q3D guideline in the European Pharmacopoeia.

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  • 01-02-2017
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

Transparency platform – Specific rules for the establishments, services and organisms of the NHS and of the Ministry of Health (Decree-Law no. 5/2017, of 6 January – Article 9)

Decree-Law no. 5/2017 approves the general principles of the advertising to medicinal products and medical devices.

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  • 31-01-2017
EMA - European Medicines Agency

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 January 2017

The European Medicines Agency´s Committee for Medicinal Products for Human Use (CHMP) recommended eight medicines for approval at its January meeting.

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  • 30-01-2017
EMA - European Medicines Agency

Post-orphan medicinal product designation procedures: guidance for sponsors

The opinions on orphan designation are adopted by the Committee for Orphan Medicinal Products (COMP) at their monthly meetings at the European Medicines Agency (EMA).

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  • 27-01-2017
EMA - European Medicines Agency

Medicine evaluation figures

The European Medicines Agency (EMA) publishes information on the volume and outcome of marketing authorisation and post-authorisation applications for human and veterinary medicines that it evaluates.

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  • 26-01-2017
ECA - European Compliance Academy

GMP Outlook for 2017 (Part 2)

There are many new developments and change notifications in the GMP area kepping the pharmaceutical industry busy, not least because many of the new requirements must be implemented soon.

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  • 25-01-2017
ICH

The M4(R4) presentation available now on the ICH Website

The Common Technical Document (CTD) is organised into five modules, including as an Annex the Granularity document that provides guidance on document location and paginations. In June 2016, this Annex was revised to add Module 2 and 3 tables and Appendices for eCTD v4, as well as, corrections to Module 2 and 3 tables for eCTD v3.2.2.

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  • 24-01-2017
EDQM

Update of application forms “Request for new CEP” and “Request for revision or renewal of CEP”

The application forms for the submission of new Certificate of Suitability applications and for requests for revision or renewal have been slightly revised in order to remove the reference to the EDQM Dropbox and submission of CD-ROM/DVD. Applicants should use the CESP (Common European Submission Portal) to submit documentation to EDQM.

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  • 23-01-2017
ICH

The Q3C(R6) Step 4 presentation available now on the ICH Website

The Q3C Guideline recommends the use of less toxic solvents in the manufacture of drug substances and dosage forms, and sets pharmaceutical limits for residual solvents (organic volatile impurities) in drug products.

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  • 20-01-2017
UK Government

Good manufacturing practice and good distribution practice

Comply with good manufacturing practice (GMP) and good distribution pratice (GDP), and prepare for an inspection.

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  • 19-01-2017
ECA - European Compliance Academy

Revised USP Chapter on Analytical Instrument Qualification

The USP has released a revision of Chapter on Analytical Instrument Qualification. This chapter set the fundamental requirements on the qualification of different types of instruments in the laboratory.

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  • 18-01-2017
EDQM

Update on the Ph. Eur. policy on elemental impurities

With the implementation of the ICH Q3D guideline on elemental impurities, the control of elemental impurities is undergoing a shift in paradigm, moving away from pure substance-based testing towards a holistic control strategy in the finished product. While these approaches are not contradictory, this change has triggered the revision of numerous texts in the European Pharmacopoeia (Ph. Eur.).

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  • 17-01-2017
EMA - European Medicines Agency

Human medicines highlights - January 2017

This newsletter provides a summary of key information relating to medicines for human use published during the previous month by the European Medicines Agency.

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  • 16-01-2017
ECA - European Compliance Academy

GMP Update - what was new in 2016?

"You get the impression that GMP is developing faster and faster". During the past year, the world of GMP turned somethat slower. Its developments in the GMP  environment remain interesting though.

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  • 13-01-2017
ICH

ICH Reflection on “GCP Renovation”: Modernization of ICH E8 and Subsequent Renovation of ICH E6

ICH is inviting public review and comment on a reflection paper on Good Clinical Pratice (GCP) "Renovation", which contains the ICH proposal for further modernization of the ICH Guidelines related to clinical trial design, planning, management, and conduct.

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  • 12-01-2017
ECA - European Compliance Academy

IMDRF publishes Guidance Draft on Clinical Studies with Software as a Medical Device

The IMDRF (International Medical Devices Regulator Forum) is the sucessor organisation of the Global Harmonisation Task Force (GHTF). Recently, the IMDRF has published a guidance draft entitled "Software as a medical Device (SAMD): Clinical Evaluation".

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  • 11-01-2017
EMA - European Medicines Agency

Setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

Update

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  • 10-01-2017
EDQM

New Chapter on Chemical Imaging in the Ph. Eur.

The chapter on Chemical Imaging (5.24) was adopted by the European Pharmacopoeia Commission at the end of November 2016. The Vibrational Spectroscopy and Analytical Data Modelling working party (VSADM) has produced the first such chapter to be included in any pharmacopoeia worldwide. This general chapter is intended to further the use of Chemical Imaging (CI) for analysing pharmaceutical products in formulation and analytical development, quality control and manufacturing environments. The final text will be published in Supplement 9.3 in July 2017.

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  • 09-01-2017
Diário da República

Decree-Law no. 5/2017 – National Official Journal no. 5/2017, Series I of 2017-01-06

Approves the general principles of the advertising to medicinal products and medical devices.

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  • 06-01-2017
EMA - European Medicines Agency

Minutes of the CAT meeting 3-4 November 2016


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  • 05-01-2017
EMA - European Medicines Agency

PRAC recommendations on signals adopted at the PRAC meeting of 28 November-1 December 2016

Adopted

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  • 04-01-2017
CEIC - Comissão de Ética para a Investigação Clínica

FAQ VALIDATION – CHANGE OF PRINCIPAL INVESTIGATOR

A new validation FAQ is published, regarding the change of principal investigator.

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  • 02-01-2017
FDA - Food and Drug Administration

FDA Clarifies Scope of Major Deficiencies in ANDA Refuse-to-Receive Guidance

The FDA has again updated on its criteria for refusing to receive an ANDA, providing a broader definition for major deficiencies and downgrading four major deficiencies to minor ones in order to make requirements less burdensome for industry.

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  • 30-12-2016
FDA - Food and Drug Administration

FDA Tweaks Guidance on Clinical Pharmacology Data for Demonstrating Biosimilarity

The FDA has made modest changes to its guidance on clinical pharmacology testing for biosimilars.

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  • 29-12-2016
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

Direct action antiviral (hepatitis C) – final recommendations

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has confirmed the recommendations disclosed in Newsletter no. 167/CD/550.20.001, of 05/12/2016.

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  • 28-12-2016
Diário da República

Order no. 16029/2016 – National Official Journal no. 246/2016, Series II of 2016-12-26

Public consultation on the Regulation variation Project regarding Prior Notice of Medicinal Product Transactions Abroad.

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  • 26-12-2016
PIC/S - Pharmaceutical Inspection Co-operation Scheme

Revision of PIC/S GMP Guide (PE 009-13)

Chapters 1, 2, 3, 6 & 7 of the PIC/S GMP Guide have been revised.

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  • 23-12-2016
Diário da República

Ordinance no. 331/2016 - National Official Journal no. 244/2016, Series I of 2016-12-22

Establishes an exceptional reimbursement regimen for the medicinal products intended for the treatment of moderate to severe oncological pain.

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  • 22-12-2016
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

Sistema de Preços de Referência - 1.º trimestre de 2017

A lista dos Grupos Homogéneos e dos preços de referência unitários a vigorar no 1º trimestre de 2017 foi aprovada pela deliberação nº 77/CD/2016, de 19 de dezembro de 2016 do Conselho Directivo e entra em vigor a 1 de janeiro de 2017.

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  • 21-12-2016
EMA - European Medicines Agency

European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes

This guidance document addresses a number of questions which marketing authorisation holders (MAHs) may have on post-authorisation procedures. It provides an overview of the Agency´s position on issues, which are typically addressed in discussions or meetings with MAHs in the post-authorisation phase.

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  • 20-12-2016
EMA - European Medicines Agency

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 December 2016

The European Medicines Agency´s Committee for Medicinal Products for Human Use (CHMP) recommended seven new medicines for marketing authorisation at its December 2016 meeting. This brings the total number of medicines recommended for approval by the CHMP in 2016 to 81.

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  • 19-12-2016
EMA - European Medicines Agency

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guideline Q3C (R6) on impurities: guideline for residual solvents - Step 5

This document recommends acceptable amounts for residual solvents in pharmaceuticals for the safety of the patient. It recommends use of less toxic solvents and describes levels considered to be toxicologically acceptable for some residual solvents.

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  • 16-12-2016
EDQM

API-mix and CEPs

EDQM has published the document "API-Mix (or mixtures) and CEPs" with regards to the acceptance of applications for CEPs where associated monograph of the European Pharmacopeia is for a mixture of an API and excipient. This clarifies the acceptability of such applications in line with the EMA Q&A on this subject which is referenced in the documnet. In addition it provides some clarification on information to be provided in the application and the information ehich will be included on the CEP for such substances.

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  • 15-12-2016
EMA - European Medicines Agency

EMA hosts workshop on adaptive pathways

The European Medicines Agency (EMA) has hosted a workshop with stakeholders to discuss adaptive pathways, an approach to medicines development that aims to facilitate access to medicines that address patients' unmet needs.

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  • 14-12-2016
ECA - European Compliance Academy

FDA Perspective on Risk Management and its Influence on Quality - Inspection Deficiencies 2015

In the framework of a conference on Quality and Manufacturing, David J. Jaworski, Senior Policy Advisor of CDER´s Office of Manufacturing and Product Quality gave a presentation on risk management and its influence on quality. The slides of his presentation are now freely available.

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  • 13-12-2016
EMA - European Medicines Agency

Human medicines highlights - November 2016

This newsletter provides a summary of key information relating to medicines for human use published during the previous month by the European Medicines Agency.

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  • 12-12-2016
ECA - European Compliance Academy

Selection and justification of starting materials: new Questions and Answers to ICH Q11 published

The ICH Q11 Guideline describing approaches to developing and understanding the manufacturing process of drug substances was finalised in May 2012. Since then the pharmaceutical industry and the drug substance manufacturers had time to get familiar with the principles outlined in this guideline. However, experience has shown that there is some need for clarification. Thus the Q11 Implementation Working Group recently issued a Questions and Answers Document.

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  • 07-12-2016
EDQM

New monograph on sodium pertechnetate (99mTc) injection (accelerator-produced) adopted

At its 156th Session the European Pharmacopeia Commission adopted the monograph on Sodium pertechnetate (99mTc) (accelerator-produced) injection (2891).

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  • 06-12-2016
EMA - European Medicines Agency

Implementation of ISO IDMP standards - Update

The European Medicines Agency (EMA) is in the process of implementing the standards developed by the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP). Following a phased implementation process, pharmaceutical companies will be required to submit data on medicines to EMA in accordance with these formats and terminologies.

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  • 05-12-2016
EDQM

Highlights 156th session of the Ph. Eur. Commission

Fourteen new texts and 52 revised monographs were adopted and the Ph. Eur. implementation strategy of the ICH Q3D guideline on elemental impurities was fine tuned.

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  • 30-11-2016
European Comission

Evaluation of the EMA fee system – terms of reference for external contract.

DG SANTE has contracted out a study to support the evaluation of the fee system of the European Medicines Agency. The project will start in December 2016 and will last for 15 months.

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  • 29-11-2016
EMA - European Medicines Agency

Active pharmaceutical ingredients: Japan joins international collaboration on GMP inspections

The ongoing collaboration on good manufacturing practice (GMP) inspections of active-pharmaceutical-ingredient (API) manufacturers between the European Medicines Agency (EMA) and its international partners is to be expanded to include Japan´s Pharmaceutical and Medical Devices Agency (PMDA).

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  • 28-11-2016
Diário da República

ORDER NO. 14202A/2016 – NATIONAL OFFICIAL JOURNAL NO. 227/2016, 1st SUPPLEMENT, SERIES II OF 2016-11-25

Under the scope of the National Programme for Prevention and Control of Smoking and of the Programme-type of action in Stopping Smoking, from the Directorate-General of Health, until the end of the year 2016 and during the year 2017, priority is given to the acess to nicotine-replacement medicinal products and to the reimbursement of the anti-smoking medicinal products subject to medical prescription.

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  • 25-11-2016
ECHA

Non-animal methods now a default for skin sensitisation – submit correct information

The new REACH requirements for skin sensitisation entered into force on 11 October 2016 making non-animal testing the default requirement. Remember to take this change into account when submitting information to ECHA, otherwise your dossier will not pass the completeness check.

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  • 24-11-2016
EDQM

Pharmacopoeial Discussion Group (PDG) Achievements

The meeting of the Pharmacopoeial Discussion Group (PDG) [European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP), and the United States Pharmacopeia (USP)] was hosted by JP in Tokyo, Japan, 24-26 October 2016. To date, 30 of the 36 General Chapters and 49 of the 67 excipient monographs on the current work programme have been harmonised. Sign-offs at this meeting include a new general chapter on Colour (Instrumental method) and a revised general chapter on Amino Acid Determination.

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  • 23-11-2016
EMA - European Medicines Agency

Guideline on the chemistry of active substances

This guideline replaces "Note for guidance on chemistry of new active substances" (CPMP/QWP/130/96, Rev 1) and "Chemistry of active substances" (3AQ5a).

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  • 22-11-2016
EMA - European Medicines Agency

Regulatory information – New guidance on type II variations and marketing authorisation extensions for orphan-designated medicines

The European Medicines Agency (EMA) has updated its post-authorisation guidance on extensions of marketing authorisations and type II variations to include further details on the information companies need to provide when submitting a type II variation or a marketing authorisation extension for an orphan-designated medicine.

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  • 21-11-2016
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

RNEC – New way of electronic submission, registration and disclosure of clinical studies

The electronic platform for registration and disclosure of clinical studies - National Register of Clinical Studies - RNEC, will be available from 5th December 2016 and will allow, at this stage, the electronic submission of the following clinical studies regarding areas regulated by Infarmed:

Clinical trials with medicinal products for human use;

Clinical studies with intervention of medical devices;

Clinical studies with intervention of cosmetic products;

Post-Authorisation Efficacy Studies (PAES) with no intervention;

Post-Authorisation Safety Studies (PASS) with no intervention.

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  • 18-11-2016
EMA - European Medicines Agency

Enpr-EMA awareness webinar

European Medicines Agency, London, UK, From: 01-Dec-2016, To: 01-Dec-2016. This webinar aims to showcase to pharmaceutical companies the benefits of working with the European Network for Paediatric Research at EMA (Enpr-EMA) and the clinical research networks it represents in the development of medicines for children.

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  • 17-11-2016
Diário da República

Ordinance no. 290-B/2016 - NATIONAL OFFICIAL JOURNAL no. 219/2016, 1st Supplement, Series I of 2016-11-15

Defines the reference countries, to be considered in 2017, for the authorization of the new medicinal products prices and for purposes of annual prices revision of the hospital market and of the ambulatory market and introduces an exceptional criterion to be applied in the prices revision system and its suspension for generic medicinal products.

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  • 16-11-2016
EMA - European Medicines Agency

European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes

This guidance document addresses a number of questions which marketing authorisation holders (MAHs) may have on post-authorisation procedures.

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  • 15-11-2016
EMA - European Medicines Agency

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 November 2016

The European Medicines Agency´s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended nine medicines for approval at its November meeting.

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  • 14-11-2016
ECHA

Update of Chesar 3 supports use maps

ECHA´s Chemical Safety Assessment and Reporting tool (Chesar) has been updated to support the use of sector-specific use maps directly in the tool. In addition, registrants can now generate their exposure scenarios for communication in a standardised ESCom XML format.

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  • 11-11-2016
DGAV - Direção-Geral de Alimentação e Veterinária

II Days of PPCIRA

The II Days of the Programme on Prevention and Control of Infection and Antimicrobial Resistance (PPCIRA) will take place in the World Antibiotic Awareness Week 2016, on the days 17th and 18th November, in the Tomé Pires Auditorium, at INFARMED.

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  • 10-11-2016
EDQM

The EDQM “Electronic submissions for CEP applications Roadmap 2016-2020” has been revised.

The EDQM roadmap for electronic submissions for CEP applications has been revised in order to align with the recently established HMA (Heads of Medicines Agencies) eSubmission Roadmap. For new CEP applications, eCTD format will become mandatory as of 1 January 2018, For revisions and renewal applications eCTD format will become mandatory as of 1 January 2020. TSE only submissions and submissions for substances for veterinary use only are exempt from this ruling.

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  • 09-11-2016
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

European campaign: Report side effects makes the medicines safer

See the campaign in the "Campanhas" area

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  • 08-11-2016
Diário da República

Order no. 13277/2016 - NATIONAL OFFICIAL JOURNAL no. 213/2016, Series II of 2016-11-07

It determines, in the scope of the National Programme for Diabetes, the development of the strategy of Access to Treatment with Devices of Continuous Subcutaneous Insulin Infusion (CSII), with the purpose of ensuring the coverage of all the population eligible in paediatric age until the year 2019.

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  • 07-11-2016
Diário da República

Ordinance no. 284-A/2016 - NATIONAL OFFICIAL JOURNAL no. 212/2016, 1st Supplement, Series I of 2016-11-04

It does the third amendment to Ordinance no. 224/2015, of 27th July, in the wording resulting from Ordinances nos. 417/2015, of 4th December, and 138/2016, of 13th May, and to its republishing (It establishes the legal regimen to which comply the rules of prescription and dispense of medicinal products and health products and defines the obligations of information to provide to the users).

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  • 04-11-2016
ECA - European Compliance Academy

FDA Guideline on "Microbiology Data for Systemic Antibacterial Drugs - Development, Analysis, and Presentation"

To assist pharmaceutical manufacturers in the development, analysis, and presentation of microbiology data during antibacterial drug development, the FDA published a guideline on "Microbiology Data for Systemic Antibacterial Drugs - Development, Analysis, and Presentation".

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  • 03-11-2016
EMA - European Medicines Agency

Paediatric requirements for marketing-authorisation applications

Applications for marketing authorisation submitted to the European Medicines Agency (EMA) that concern medicines not authorised in the European Union (EU) on 26 July 2008 must include the results of studies carried out as part of an agreed paediatric investigation plan (PIP) or information on a PIP deferral or waiver.

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  • 02-11-2016
ECHA

New features in biocides IT tools

The biocides submission tool (R4BP 3) has been updated to support new features for Union authorisation and authorisation of same biocidal products. The tool for creating summaries of product characteristics (SPC Editor) now supports the creation of a biocidal product family with sub-families.

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  • 27-10-2016
EMA - European Medicines Agency

Annual Report of the GMP/GDP Inspectors Working Group published

EMA´s GMP/GDP Inspectors Working Group has published the 2015 annual report summarising its activities.

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  • 26-10-2016
EMA - European Medicines Agency

Regulatory update – EMA encourages companies to submit Type I variations for 2016 by end of November

The European Medicines Agency (EMA) is advising marketing authorisation holders to submit any Type IAIN and Type IA variations for 2016 by Wednesday 30 November. This will enable the Agency to acknowledge the validity of the submissions before the Agency´s closure between 23 December 2016 and 2 January 2017 within the 30-day timeframe set out in Article 14 of Commission Regulation (EC) No 1234/2008.

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  • 25-10-2016
European Comission

Commission launches public consultation on strengthening EU cooperation on Health Technology Assessment

Launch of public consultation on the Commision initiative for strenghening EU cooperation on health technology assessment (HTA).

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  • 24-10-2016
EMA - European Medicines Agency

Clinical data publication

As of October 2016, the European Medicines Agency (EMA) publishes clinical data submitted by pharmaceutical companies to support their regulatory applications for human medicines under the centralised procedure. This is based on EMA´s flagship policy on the publication of clinical data.

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  • 21-10-2016
ICH

New ICH M9 Guideline in development on Biopharmaceutics Classification System (BCS)-based biowaivers

In October 2016, the ICH endorsed a new topic for the development of a new multidisciplinary guideline to address Biopharmaceutics Classification System (BCS)-based biowaivers. This guideline will provide recommendations to support the biopharmaceutics classification of medicinal products and will provide recommendations to support the waiver of bioequivalence studies.

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  • 20-10-2016
ECA - European Compliance Academy

Ph. Eur. Draft Chapter 3.2.1 "Glass containers for pharmaceutical use"

A draft of a revised version of Ph. Eur. General Chapter 3.2.1 "Glass Containers for Pharmaceutical Use" has been published in Pharmeuropa 28.4 Comments regarding this draft can be suvmitted until 31. December 2016.

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  • 19-10-2016
FDA - Food and Drug Administration

Draft Guidance Outlines Procedure for Clinical Evaluation of Software as a Medical Device

The draft guidance addresses stand-alone software designed to produce or extract data.

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  • 18-10-2016
EMA - European Medicines Agency

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 October 2016

The European Medicines Agency´s Committee for Medicinal Products for Human Use (CHMP) recommended eight medicines for approval at its October meeting.

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  • 17-10-2016
EMA - European Medicines Agency

ICH E11(R1) guideline on clinical investigation of medicinal products in the pediatric population: Step 2b

Draft: consultation open

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  • 14-10-2016
FDA - Food and Drug Administration

FDA Adds Technical Requirements for Electronic Submission of Study Data

Before the end of the year, the FDA will begin requiring that study data for NDA, BLA, and ANDA submissions be submitted to the agency in a standardized electronic data format.

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  • 13-10-2016
ECA - European Compliance Academy

What are the GMP Responsibilities of the Marketing Authorisation Holders?

The GMP/GDP Inspectors Working Group of the European Medicines Agency (EMA) has published a concept paper to summarise the GMP responsibilities of the Marketing Authorisation Holders (MAH).

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  • 12-10-2016
EMA - European Medicines Agency

Agenda - CHMP agenda of the 10-13 October 2016

Draft agenda for the meeting on 10-13 October 2016

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  • 11-10-2016
EMA - European Medicines Agency

Pre-submission checklist for 5-year renewal applications

The purpose of this checklist is facilitating submission of complete and correct 5-year Renewal Applications by marketing authorisation holders (MAHs).

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  • 10-10-2016
Diário da República

Ordinance no. 262/2016 - NATIONAL OFFICIAL JOURNAL no. 193/2016, Series I of 2016-10-07

Regulates the specific compensation given to pharmacies due to dispense of reimbursed medicinal products, according to the reduction of the reference prices.

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  • 07-10-2016
ECA - European Compliance Academy

USP announced Major Revision of General Chapter

The United States Pharmacopeia (USP) Expert Committee on General Chapters - Dosage Forms announced a major revision of general chapter Tablet Breaking Force. Comments can be submitted until October 15, 2016.

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  • 06-10-2016
EDQM

EDQM enhances sharing of information with Japanese regulatory authorities and strengthens collaboration with Japanese Pharmacopoeia

The EDQM has agreed with the Japanese authorities to improve the sharing of information related to therapeutic products that are common to both Europe and Japan, and to strengthen collaboration between the European and Japanese Pharmacopeias.

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  • 04-10-2016
EMA - European Medicines Agency

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 26-29 September 2016

During its monthly meeting, the European Medicines Agency´s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) focused on the broad spectrum of its responsibilities which cover all aspects of the risk management of the use of medicines. The committee did not initiate or conclude a referral.

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  • 03-10-2016
EMA - European Medicines Agency

Dossier requirements for referral, active substance master files (ASMF) and nationally authorised products (NAPs) submissions (PASS107, workshare, signal detection procedures) and ancillary medicinal substances in a medical device

Update

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  • 30-09-2016
ECA - European Compliance Academy

New MEDDEV Document on the Clinical Evaluation of Medical Devices

To put EU Medical Devices (93/42/EEC and 90/385/EEC) in concrete terms, the EU issues so-called MEDDEV documents. In this context, the document MEDDEV 2.7/1 revision 4 entitled "Clinical Evaluation: A Guide for Manufacturers and Notified Bodies under Directives 93/42/EEC and 90/385/EEV" has been newly published.

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  • 29-09-2016
Diário da República

Ordinance no. 256/2016 - NATIONAL OFFICIAL JOURNAL no. 187/2016, Series I of 2016-09-28

Approves the principles and standards of good distribution practice of medical devices (listed in the annex) to be considered by the entities that exercise the activity of medical device wholesale distribution

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  • 28-09-2016
Diário da República

Ordinance no. 255/2016 - NATIONAL OFFICIAL JOURNAL no. 186/2016, Series I of 2016-09-27

Amends the Ordinance no. 223/2015, of July 27 [Regulates the procedure of payment of the State reimbursement in the retail selling price (PVP) of the medicinal products made available to beneficiaries of the National Health Service (NHS) and of public subsystems that are the NHS responsibility, or that benefit from reimbursement in regime of complementary].

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  • 27-09-2016
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

Joint Newsletter no. 8/2016/ACSS/INFARMED/SPMS – update of health care goods and services that should be object of centralised acquisition

Please find the joint newsletter attached.

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  • 26-09-2016
FDA - Food and Drug Administration

FDA Reviews Questions on ICH Guidance for Nonclinical Evaluation of Cancer Drugs

The FDA is taking public questions and comments relating to implementing a global guidance from 2010 on the nonclinical evaluation of anticancer drugs, also known as the S9 guidance, developed by the International Council for Harmonisation.

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  • 23-09-2016
EMA - European Medicines Agency

PRIME: priority medicines

PRIME is a scheme launched by the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need. This voluntary scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimise development plans and speed up evaluation so these medicines can reach patients earlier.

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  • 22-09-2016
EMA - European Medicines Agency

Task force for the implementation of International Standards on Identification of medicinal products in the EU (i.e. EU ISO IDMP task force)

Update

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  • 21-09-2016
ECA - European Compliance Academy

GVP Update

Eudralex Volume 9 - Guideline on good pharmacovigilance practices (GVP) now comprises several updates.

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  • 20-09-2016
European Comission

Inception Impact Assessment on Strengthening of the EU cooperation on Health Technology Assessment (HTA)


read more >

  • 19-09-2016
ECHA

September Newsletter gives practical advice to registrants

This issue includes useful advice to companies who are preparing their submissions for the REACH 2018 registration deadline  and explains how ECHA checks the completeness of registration dossiers. We also look back on the past three years of the Biocidal Products Regulation and give an update on where we are today. In addition, you can read interviews with experts on substitution, socio-economic analysis and the circular economy.

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  • 16-09-2016
EMA - European Medicines Agency

Progress made in the operation of EU pharmacovigilance legislation

The European Medicines Agency (EMA) is organising the tenth stakeholder forum on the operation of the pharmacovigilance legislation on 21 September 2016. This is the latest in a series of events organised by EMA to review the progress made and to consult stakeholders on what needs to be the focus over the coming years.

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  • 15-09-2016
ECA - European Compliance Academy

Analytical Lifecycle: USP "Statistical Tools", Analytical Target Profile and Analytical Control Strategy

The United States Pharmacopeia (USP) is currently undertaking further steps towards a comprehensive analytical lifecycle approach by publishing a draft of a new General Chapter Statistical Tools for Procedure Validation and two Stimuli Articles regarding Analytical Target Profile and Analytical Control Strategy in Pharmacopeial Forum.

read more >

  • 14-09-2016
EMA - European Medicines Agency

Application form for the involvement of industry stakeholder organisations in the activities of the European Medicines Agency (EMA)

Further to the adoption of the Framework for interaction between the European Medicines Agency and industry stakeholders in October 2015, this application form has been created of the Agency to evaluate whether a specific industry stakeholder organisation fulfils the elegibility criteria for involvement in the Agency´s activities.

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  • 13-09-2016
Diário da República

Decree-Law no. 62/2016 - NATIONAL OFFICIAL JOURNAL no. 175/2016, Series I of 2016-09-12

It establishes the terms and conditions of the provision of intervention services in public health by the community pharmacies, as well as the possibility of awarding a specific compensation to the pharmacies due to dispense of reimbursed medicinal products, namely in the medicinal products inserted in homogeneous groups.

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  • 12-09-2016
UK Government

Advertise your medicines

How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines.

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  • 09-09-2016
EMA - European Medicines Agency

Fighting antimicrobial resistance globally

Alignment of data requirements by regulators worldwide can contribute to stimulate the development of new antibiotics to fight antimicrobial resistance and protect global public health.

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  • 08-09-2016
EMA - European Medicines Agency

Signal detection and management information day

This information day will review signal detection and management activities essential to the overall risk management process of a medicinal product.

read more >

  • 07-09-2016
EMA - European Medicines Agency

Important medical event terms list (MedDRA version 19.1)

Update

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  • 06-09-2016
EMA - European Medicines Agency

Highlights from the European Medicines Agency industry platform meeting held on 21 April 2016 on the operation of the centralised procedure for human medicinal products

The purpose of these platform meetings between regulators and representatives of industry stakeholder organisations is to provide an opportunity for both general updates and more focused discussions on specific processes or issues to support continuous improvement, and generally to foster a constructive dialogue with industry stakeholders.

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  • 05-09-2016
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

Communication of Notified Prices through GAM

With the purpose of facilitating the process of communication of notified prices, the Management of Accessibility to Medicinal Product (GAM) application was updated with a new module, available from 01/09/2016 – GAM – Module 10 – Regimen of Notified Prices.

read more >

  • 02-09-2016
ECA - European Compliance Academy

EMA - requirements for quality documentation concerning biological investigational medicinal products

The European Medicines Agency published a draft “Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials”.

read more >

  • 01-09-2016
ECA - European Compliance Academy

USP revised about thirty Ophthalmic Ointment Monographs

On July 29, 2016, the United States Pharmacopeia (USP) posted a new Revision Bulletin regarding approximately thirty Ophthalmic Ointment Monographs.The revised monographs became official on August 1, 2016.

read more >

  • 31-08-2016
FDA - Food and Drug Administration

FDA Asks Manufacturers of Syringe Pumps to Revise Labels, Warnings

Manufacturers of syringe pumps are being asked to update their labels to address flow continuity concerns that the FDA has identified as a serious risk to health. 

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  • 30-08-2016
EMA - European Medicines Agency

Minutes of the PRAC meeting 06-09 June 2016

Pharmacovigilance Risk Assessment Committee (PRAC)

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  • 29-08-2016
EMA - European Medicines Agency

Questions and answers on signal management

Update

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  • 25-08-2016
ECA - European Compliance Academy

Implementation of ICH Q3D within the CEP Procedure

The EDQM has implemented the requirements of the ICH Q3D Guideline on elemental impurities also for the CEP procedure and has published a new policy document. Read more here about what has to be considered when applying or renewing a CEP, or for already existing CEPs with regard to elemental impurities in APIs.

read more >

  • 24-08-2016
ECHA

REACH 2018: Assess your substance to show safe use

Companies registering the same substance must work together to compile and share information on the uses, hazards and risks of their substance to demonstrate safe use. If new data involving animal testing needs to be generated, alternatives must always be considered first. All information should be reported in a registration dossier and submitted to ECHA by 31 May 2018.

read more >

  • 23-08-2016
UK Government

Send and receive information on adverse drug reactions (ADRs)

How marketing authorisation holders should inform MHRA of an ADR to a medicine, using the E2B messaging system.

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  • 22-08-2016
EMA - European Medicines Agency

Signal management

Designated medical events (update). EMA has developed a list of designated medical events containing medical conditions that are inherently serious and often medicine-related. It does not address product specific issues or medical conditions with high prevalence in the general population. The list contains Medical Dictionary for Regulatory Activities (meDRA) terms and serves as a safety net in signal detection.

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  • 19-08-2016
ECA - European Compliance Academy

Is AQL Testing required within the 100% Visual Inspection?

One of the most frequently asked questions is whether an additional testing based on samples is required after the 100% visual inspections of parenterals. The answer is: basically, "yes". 

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  • 18-08-2016
EMA - European Medicines Agency

Guideline on good pharmacovigilance practices (GVP): Product- or population-specific considerations II: Biological medicinal products with tracked changes

Track-change version

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  • 16-08-2016
EMA - European Medicines Agency

Data integrity: key to public health protection

The European Medicines Agency (EMA) has released new good manufacturing practice (GMP) guidance to ensure the integrity of data that are generated in the process of testing, manufacturing, packaging, distribution and monitoring of medicines. Regulators rely on these data to evaluate the quality, safety and efficacy of medicines and to monitor their benfit-risk profile throughout their life span. Controlling of data records helps ensure that the data generated are accurate and consistent to support good decision-making by both pharmaceutical manufacturers and regulatory authorities.

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  • 12-08-2016
ECA - European Compliance Academy

EMA publishes Q&A Document on Production of WFI not obtained by Distillation

The revision of chapter 0169 of the European Pharmacopoeia will introduce in Europe as of April 2017 the possibility to produce WFI using other techniques than distillation. However, many questions are still unanswered like for example how the robustness of the new procedure compared to distillation should be demonstrated. The now published paper has been therefore highly antecipated.

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  • 11-08-2016
EMA - European Medicines Agency

Human medicines highlights - July 2016

The newsletter is addressed primarily to organisations representing patients, consumers and healthcare professionals. It provides a summary of key information relating to medicines for human use published during the previous month by the European Medicines Agency.

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  • 10-08-2016
UK Government

Send and receive information on adverse drug reactions (ADRs)

How marketing authorisation holders should inform MHRA of an ADR to a medicine, using the E2B messaging system.

read more >

  • 08-08-2016
EMA - European Medicines Agency

Guideline on the processing of renewals in the centralised procedure

Adopted

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  • 05-08-2016
ECA - European Compliance Academy

What does Brexit mean for the QP?

The decision of the U.K. to leave the EU has caused a high uncertainty throuhgout industry - and also in the pharmaceutical industry. The European QP Association has received a number of questions on what Brexit actually means for QPs. For that reason the EQPA leadership team has prepared some information.

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  • 04-08-2016
EMA - European Medicines Agency

PRAC recommendations on signals adopted at the PRAC meeting of 4-8 July 2016

Adopted

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  • 03-08-2016
ECA - European Compliance Academy

WHO Technical Report - GMP for Biological Products adopted

As a part of their Technical Report Series with guidance documents comprising recommendations for biological products, the The World Health Organization (WHO) now published "Annex 2 - WHO good manufacturing practices for biological products".

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  • 02-08-2016
EMA - European Medicines Agency

Annual report of the Pharmacovigilance Inspectors Working Group for 2015

This document is the eighth annual report of the Pharmacovigilance Inspectors Working Group (PhV IWG). The PhV IWG has been established by the European Medicines Agency (hereinafter "the Agency") within the scope of Article 57(1)(i) of Regulation (EC) No. 726/2004.

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  • 01-08-2016
EMA - European Medicines Agency

Quality of medicines questions and answers: Part 1

Update

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  • 29-07-2016
EDQM

Revision of application forms “Request for new Certificate of Suitability” and “Request for revision or renewal of Certificate of Suitability”

The application forms for the submission of new CEP applications and for requests for revision/renewal have been slightly revised.

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  • 28-07-2016
ECA - European Compliance Academy

WHO Draft on Analytical Method Validation

The World Health organization (WHO) recently published a draft document on analytical method Validation for comment.

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  • 27-07-2016
UK Government

Good pharmacovigilance practice (GPvP)

Comply with good pharmacovigilance pratice, complete a compliance report and prepare for an inspection.

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  • 26-07-2016
EMA - European Medicines Agency

EMA recommends suspension of medicines over flawed studies at Semler Research Centre

The European Medicines Agency (EMA) has recommended suspending a number of nationally approved medicines for which bioequivalence studies were conducted at Semler Research Centre Private Ltd., Bangalore, India. The Agency has also recommended that medicines currently being evaluated for aulthorisation and which rely only on bioequivalence studies from this site should not be authorised until bioequivalence is demonstrated using alternative data.

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  • 25-07-2016
UK Government

MHRA GxP Data Integrity Definitions and Guidance for Industry

MHRA has produced draft GxP data integrity guidance for industry and they welcome your comments.

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  • 22-07-2016
ECA - European Compliance Academy

Elaboration of New USP General Chapter - Analytical Procedure Lifecycle - announced

On June 24, 2016, the USP announced the elaboration of a new general chapter regarding life cycle management of analytical methods.

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  • 21-07-2016
EMA - European Medicines Agency

Agenda - CHMP agenda of the 18-21 July 2016 meeting

CHMP agenda of the 18-21 July 2016 meeting

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  • 20-07-2016
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

System of Reference Prices – Amendment of new homogeneous groups

The list of Homogeneous Groups and of unit reference process to be in force in the 3rd trimester of 2016 will be updated with the inclusion of 4 new homogeneous groups, for which the reference price was approved (GH1078, GH1079, GH1080 and GH1081) - diclofenac + misoprostol, modified-release tablet, 75 mg + 0,2 mg and omeprazole, gastro-resistant capsule, 10 mg.

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  • 19-07-2016
EFSA - European Food Safety Authority

Health claims guidance update – have your say on revised scientific and technical requirements

EFSA has launched a public consultation on its revised scientific and technical guidance for the preparation and presentation of a health claim application. Interested parties have until 12 September 2016 to submit comments on the draft document.

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  • 18-07-2016
ECA - European Compliance Academy

ICH M4E(R2) Guideline reaches Step 4 of the ICH Process

The revised version of the ICH M4E(R1) Guideline on Enhancing the Format and Structure of Benefit-Risk Information in ICH reached Step 4 of the ICH Process in June 2016 and now enters the implementation period (Step 5).

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  • 15-07-2016
ECA - European Compliance Academy

Example by Inspectorate for Handling Temperature Excursions

In a recent blog, the MHRA is illustrating its opinion with an example of a short-term temperature excursion during the transport of a product from a third country to the EU.

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  • 14-07-2016
EMA - European Medicines Agency

Draft implementation strategy of ICH Q3D guideline

Draft: consultation open

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  • 13-07-2016
ICH

ICH E17 Guideline reaches Step 2b of the ICH Process

The ICH E17 Guideline on Multi-Regional Clinical Trials reaches Step 2b of the ICH Process in June 2016 and now enters the consultation period (Step 3). This new ICH Guideline is proposed to provide guidance on general principles on planning/designing Multi-Regional Clinical Trial (MRCT).

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  • 12-07-2016
FDA - Food and Drug Administration

EU Aims For U.S., EU Regulatory Harmonization on Approval, Guidelines and GMP

The European Union wants to expand ongoing trade talks between the U.S. and EU to address regulatory harmonization on drug approval requirements, guidelines and GMP compliance.

read more >

  • 11-07-2016
EMA - European Medicines Agency

Pharmacovigilance fees: questions and answers

Update

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  • 08-07-2016
EMA - European Medicines Agency

Questions and answers: Article 29(4) referral procedures

This page lists questions that stakeholders, particulary marketing authorisation holders (MAHs)/applicants, may have on Article 29(4) referral procedures.

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  • 07-07-2016
ECA - European Compliance Academy

WHO publishes Draft of an Umbrella Guideline on Process Validation

At the end of 2015, the WHO adapted its Appendix 7 to the latest technological standards. Appendix 7 provides support with regard to non-sterile process validation. Now, further changes to WHO guidelines are in sight. One of these changes concerns the guideline on process validation which is currently available as a draft and can be commented on until July, 12th 2016.

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  • 06-07-2016
EMA - European Medicines Agency

PRAC recommendations on signals adopted at the PRAC meeting of 6-9 June 2016

This document provides an overview of the recommendations adopted by the Pharmacovigilance Risk Assessment Committee (PRAC) on the signals discussed during the meeting of 6-9 June 2016 (including the signal European Pharmacovigilance Issues Tracking Tool [EPITT] reference numbers).

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  • 05-07-2016
EMA - European Medicines Agency

Pharmacovigilance fees payable to the European Medicines Agency

Update

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  • 04-07-2016
CMDh - Co-ordination group for Mutual recognition and Decentralised procedures - Human

Q&As on Variations

Update

read more >

  • 01-07-2016
EMA - European Medicines Agency

List of medicines under additional monitoring

Update

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  • 30-06-2016
ECA - European Compliance Academy

Annex 16: How a QP should handle unexpected Deviations

In a recent blog of MHRA, the inspectorate looks at one aspect of the new Annex 16 - the handling of unexpected deviations.

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  • 29-06-2016
UK Government

Medicines and Healthcare products Regulatory Agency statement on the outcome of the EU referendum

The Agency´s response to the outcome of the EU referendum.

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  • 28-06-2016
EMA - European Medicines Agency

EMA public workshop on extrapolation of efficacy and safety in medicine development

Update - European Medicines Agency, London, UK, From: 17-May-2016, To: 18-May-2016

read more >

  • 27-06-2016
EMA - European Medicines Agency

Q&A: Type II variations

Update: Medicines for veterinary use
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  • 24-06-2016
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

Variations and Revocations of Medicinal Products Prices

Newsletter no. 096/CD/8.1.6 - Regimen of Notified Prices.

read more >

  • 23-06-2016
EMA - European Medicines Agency

European Union (EU) workshop on ICH Q3D from a quality perspective

Update: European Medicines Agency, London, UK, From: 05-Apr-2016, To: 06-Apr-2016
read more >

  • 22-06-2016
ECA - European Compliance Academy

Current Issues of GDP Oversight

Since the publication of the EU GDP Guideline in March 2013 various measures for GDP oversight have been taken. While comprehensive measures exist in the area regulated by the EU GDP guidelines, there still are areas where oversight is insufficient or where diverse interpretations raise questions and issues.
read more >

  • 21-06-2016
EMA - European Medicines Agency

Electronic submission of Article 57(2) data: questions and answers

Update

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  • 20-06-2016
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

System of Reference Prices – 3rd Trimester of 2016

The list of Homogeneous Groups and the unit reference prices to be force in  the 3rd trimester of 2016 was approved by delibaration no. 53/CD/2016, of 9 June 2016, of the Board of Directors, and enters into force on 1 July 2016
read more >

  • 17-06-2016
ECA - European Compliance Academy

FDA releases new internal policy on ICH Q8, Q9, Q10 Guidelines

On May 18, 2016, the US Food and Drug Administration (FDA) released a new policy document on applying ICH Q8, Q9, and Q10 principles to chemistry, manufacturing, and controls review.

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  • 16-06-2016
ECA - European Compliance Academy

Revision of the general Chapter on Pharmaceutical Water in the US Pharmacopoeia

The 2nd supplement of USP39 NF34 comprises the revised version of the chapter on pharmaceutical water of the US Pharmacopeia Water for pharmaceutical purposes.

read more >

  • 15-06-2016
EMA - European Medicines Agency

Periodic safety update reports

This page includes information on periodic safety update reports (PSURs), European Union (EU) reference dates for medicines and the frequency of submission of PSURs.

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  • 14-06-2016
European Comission

Leaflet - eHealth: connecting health systems in Europe

Leaflet - eHealth: connecting health systems in Europe.


read more >

  • 09-06-2016
ECA - European Compliance Academy

TTIP: The End of FDA Inspections in Europe?

Would the implementation of TTIP bring an end to FDA inspections in the EU? This is discussed in the EU proposal for a respective annex on medicinal products.

read more >

  • 08-06-2016
CMDh - Co-ordination group for Mutual recognition and Decentralised procedures - Human

Requirements on submissions (number and format) for Variations and Renewals within MRP and National procedures

Update

read more >

  • 07-06-2016
EMA - European Medicines Agency

Regulation of advanced therapy medicines

The European Medicines Agency (EMA) published a report from a multi-stakeholder expert meeting held on 27 May 2016 to explore possible ways to foster the development of ATMPs in Europe and expand patients acess to these new treatments.

read more >

  • 06-06-2016
EMA - European Medicines Agency

European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes

Update

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  • 03-06-2016
EMA - European Medicines Agency

Regulatory information – A new operating model for procedure management to improve support for evaluation procedures

The Agency is introducing a new operating model for the management of evaluation procedures. With the new model procedure managers and procedure assistants will be allocated per product, rather than per procedure, in order to improve the co-ordination of regulatory activities with a product, particularly where multiple regulatory procedures are run in parallel for same product. The strong procedural focus that has already been archieved with the current model will be maintained and strengthened throught the creation of process-focused communities that comprise EMA staff specialising in specific procedures.

read more >

  • 02-06-2016
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

Newsletter no. 082/CD/100.20.200. – 30/05/2016 – Communications Platform – Transparency and Publicity

The Communications Platform - Transparency and Publicity was updated in order to facilitate its use, as well as bearing in mind its inclusion in the NHS Portal.

read more >

  • 31-05-2016
Diário da República

Ordinance no. 154/2016 - NATIONAL OFFICIAL JOURNAL NO. 102/2016, Series I of 2016-05-27

Regulates the regimen of prices notified of the medicinal products subject to medical prescription not reimbursed or non-reimbursable, in the terms of Ordinance no. 195-C/2015, of 30 June.

read more >

  • 30-05-2016
ECA - European Compliance Academy

WHO issues revised Guideline on HVAC Systems

The World Health Organization (WHO) recently issued a guideline for commenting which describes the requirements for HVAC systems for the manufacture of non-sterile forms. As most guidelines on this address on this topic address the requirements for sterile dosage forms, the previous version was gladly accepted by industry.

read more >

  • 25-05-2016
ECA - European Compliance Academy

EMA post-authorisation procedural advice for users of the centralised procedure

The European Medicines Agency (EMA) recently published an updated Questions and Answers paper on post-authorisation procedural advice for users of the centralised procedure.

read more >

  • 24-05-2016
EMA - European Medicines Agency

Accessing key EMA information on human medicines

A guide, released last week by the European Medicines Agency (EMA), describes information the Agency publishes on centrally and non-centrally authorised medicines for human use.

read more >

  • 23-05-2016
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

INFARMED SIMPLEX: Licensing of pharmacies and saving in medicinal products will be simpler.

The licensing of pharmacies will be a simplex process, totally performed in an electronic portal associated to the website INFARMED, I.P.. This will be on of the nine ambitious SIMPLEX + measures allocated to the medicinal product regulator, which will benefit more than thousand addressees, between pharmacies, companies and entrepreneurs. The 255 Simplex measures were public announced yesterday.

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  • 20-05-2016
EMA - European Medicines Agency

Progress in science, medicine and health

The European Medicines Agency´s (EMA) 2015 annual report published today focuses on the Agency´s core tasks which include the evaluation of medicines, support to research and development of new and innovative treatments and the monitoring of the benefits and risks of medicines in real life.

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  • 19-05-2016
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

Press Release – Infarmed reassesses the reimbursement of 115 more expensive medicinal products

INFARMED, I.P. is reassessing the reimbursement of the non-generic (brand) medicinal products that have a price 20% higher than therapeutic alternatives used with the same purpose and also non-generic. This reassessment may imply the non-reimbursement of these medicinal products, unless the laboratories making them available adjust the prices down to this limit.

read more >

  • 18-05-2016
CMDh - Co-ordination group for Mutual recognition and Decentralised procedures - Human

CMDh Best Practice Guide on the compilation of the dossier for New Applications submitted in Mutual Recognition and Decentralised Procedures (May 2016)

The objective for this Best Practice Guide (BPG) is to emphasise the importance of taking care in the compilation of the dossier for a Marketing Authorisation Application (MAA), to minimise delays in validation, to avoid invalidation of submissions, to forestall questions from Member States (both RMS and CMS), and to enhance the efficiency of the regulatory process.

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  • 17-05-2016
EMA - European Medicines Agency

Draft reflection paper on the dissolution specification for generic oral immediate release products

Draft: consultation open

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  • 16-05-2016
EMA - European Medicines Agency

Can regulators influence the affordability of medicines?

The growing problem of high medicine prices and its impact on the sustainability of health care systems is getting more and more attention in many countries around the globe. Regulators are willing to play their part in solving the problem and in facilitating continued access of patients to safe and effective medicines. In an article published yesterday in the New England Journal of Medicine (NEJM) two representatives of the European Medicines Agency (EMA), i.e. its Executive Director and Senior Medical Officer, as well as Heads of two national agencies discuss possible regulatory interventions.

read more >

  • 13-05-2016
European Comission

NTA update of volume 6A

Volume 6 of the publications "The rules governing medicinal products in the European Union" contains a list of regulatory guidelines related to procedural and regulatory requirements such as renewal procedures, dossier requirements for Type IA/IB variation notifications, summary of product characteristics (SPC), package information and classification for the supply, readability of the label and package leaflet requirements.

read more >

  • 12-05-2016
ECA - European Compliance Academy

USP publishes draft of a new general chapter <661.3> for plastic components used in manufacturing

In the Pharmacopoeial Forum (PF)  42(3) (May-June 2016) the USP General Chapters - Packaging and Distribution Expert Committee proposes a new chapter to address the qualification of plastic components used in the manufacture of APIs (pharmaceutical and biopharmaceutical) and drug products (DPs). The proposed Title of the new chapter <661.3> is Plastic Components and Systems Used in Pharmaceutical Manufacturing.

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  • 11-05-2016
Diário da República

Deliberation no. 797/2016 - NATIONAL OFFICIAL JOURNAL NO. 89/2016, Series II of 2016-05-09

Extinction of the Unit of Information Mangement; creation of the Unit of Management of the Medicinal Product and Medical Devices Account

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  • 10-05-2016
UK Government

Decide if your product is a medicine or a medical device

How the Medicines and Healthcare products Regulatory Agency (MHRA) makes decisions on what is a medicine or medical device (borderline products).

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  • 09-05-2016
EMA - European Medicines Agency

Excipients labelling

The European Medicines Agency (EMA) published background documents on excipients for inclusion in the label and package leaflet of human medicines.

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  • 05-05-2016
ECA - European Compliance Academy

EMA publishes finalised Process Validation Guideline for Biotech Products

Approximately two years ago the EMA published a draft guideline on process validation for the manufacture of biotech products. Now the final guideline has been published under the title "Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission."

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  • 04-05-2016
PHAGECON

Training course on Variations – Filling Variations (23-24/05/2016)

The increasing growth of the volume and complexity of the regulatory requirements related to the Filling and Submission of Variations has been a constant in the life of all the Regulatory Affairs professionals and of many other professionals.

Having identified this gap in the panorama of services provided in Portugal, Phagecon will organise, on the days 23 and 24 May in Lisbon, the training “Filling Variations”.

This training will be given by Andrew Willis, a professional with 30 years of experience in some of the biggest companies of the world and that gives the same training in the reputable PTI (Pharmaceutical Training International),

Take advantage of the last seats available of this excellent opportunity. Come enjoy top training in the entire World.

To do so just click on the link below and fill the applicable form and send the proof of payment with identification of the company and trainee to the email – training@phagecon.pt

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  • 03-05-2016
EMA - European Medicines Agency

List of medicinal products under additional monitoring

Update

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  • 28-04-2016
EMA - European Medicines Agency

Article 58 applications: Regulatory and procedural guidance

Article 58 of Regulation (EC) No 726/2004 allows the Agency´s Committee for Medicinal Products for Human Use (CHMP) to give opinions, in co-operation with the World Health Organization (WHO), on medicinal products for human use that are intended exclusively for markets outside of the European Union (EU).

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  • 27-04-2016
EMA - European Medicines Agency

Integrating patients’ views in clinical studies of anticancer medicines

The European Medicines Agency (EMA) has published new guidance on the use of patient-reported outcome (PRO) measures in oncology studies. The new guidance is an appendix to the guideline on the evaluation of anticancer medicinal products in man, which was last revised in July 2013. read more >

  • 26-04-2016
EMA - European Medicines Agency

Quality of medicines questions and answers: Part 1

These questions and answers address a number of questions that have been brought to the attention ot the Joint Committee for Medicinal Products for Human Use / Committee for Medicinal Products for Veterinary Use Quality Working party (QWP) by marketing-authorisation holders (MAHs) or European Economic Area (EEA) competent authorities, on matters related to the quality of medicines. They have developed and are maintained by the QWP.

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  • 22-04-2016
EMA - European Medicines Agency

Draft concept paper on an addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 Rev. 2) to address paediatric-specific clinical data requirements

Draft: consultation open

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  • 21-04-2016
ECA - European Compliance Academy

GMP/GDP: When will I be inspected by the Authoritie

Various competent authorities are performing inspections. But who is subject to such an inspection?

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  • 20-04-2016
UK Government

Good laboratory practice (GLP) for safety tests on chemicals

As a test facility, comply with regulatory requirements for carrying out product safety tests for human health, animal health or the environment. read more >

  • 19-04-2016
EMA - European Medicines Agency

Briefing note to marketing authorisation holders/applicants on the European Medicines Agency Patient Registry Initiative

Through the Patient Registry Initiative launched in September 2015, the EMA aims to facilitate interactions between registry co-ordinators and potential users of registry data both at an early stage of the development, during the marketing authorisation evaluation procedure and post-authorisation.

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  • 18-04-2016
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

Update of the list of medicinal products subject to previous notification of exportation or distribution to other member-states

Deliberation no. 661/2016, of 26 March, updates the list of medicinal products whose consumptions, exportation of distribution to other Member-States of the European Union depend on the notification to Infarmed. This list enters into force on the 5th day after being published, i.e., on 20th April.

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  • 15-04-2016
EMA - European Medicines Agency

Draft guideline on the sterilisation of the medicinal product, active substance, excipient and primary container

Draft: consultation open

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  • 14-04-2016
Diário da República

Deliberation no. 662/2016 - National Official Journal no. 72/2016, Series II of 2016-04-13

Regulation of functioning of the Evaluation Committee of the Health Technologies - CATS read more >

  • 13-04-2016
European Comission

Methodological guidelines and recommendations for efficient and rational governance of patient registries

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  • 12-04-2016
EMA - European Medicines Agency

Implementation of the ISO IDMP standards

The European Medicines Agency (EMA) is in the process of implementing the standards developed by the International Organization for StandardizationExternal link icon (ISO) for the identification of medicinal products (IDMP). These are a set of common global standards for data elements, formats and terminologies for the unique identification of and the exchange of information on medicines. Following a phased implementation process, pharmaceutical companies will be required to submit data on medicines to EMA in accordance with these formats and terminologies. read more >

  • 11-04-2016
EMA - European Medicines Agency

List of European Union reference dates and frequency of submission of periodic safety update reports

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  • 08-04-2016
EMA - European Medicines Agency

Minutes of the CHMP meeting 22-25 February 2016

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  • 07-04-2016
ECA - European Compliance Academy

The new Annex 16 is coming into Force

The new Annex 16 "Certification by a Qualified Person and Batch Release" will become effective as of 15 April 2016. The contents will reflect the coming state of expectations regarding the batch release. read more >

  • 06-04-2016
EMA - European Medicines Agency

Orphan designation

This section provides guidance and procedural information on applying for orphan designation for medicines for rare diseases in the European Union (EU). It also includes information on what happens after a designation has been granted, including the incentives available for sponsors developing orphan medicines. read more >

  • 05-04-2016
EMA - European Medicines Agency

Fees payable to the European Medicines Agency

The European Medicines Agency charges fees for the services it provides. The rules relating to the Agency's fees are governed by the fee Regulation (Council Regulation (EC) No 297/95) and its implementing rules, as well as the pharmacovigilance fee Regulation (Regulation (EU) No 658/2014).   read more >

  • 04-04-2016
EMA - European Medicines Agency

Parallel scientific advice from regulators and health-technology-assessment bodies

The European Medicines Agency (EMA) offers scientific advice and protocol assistance in parallel with health-technology-assessment (HTA) bodies. This procedure aims to allow medicine developers to gain feedback from regulators and HTA bodies at the same time, at any point in the developmental lifecycle of medicines. This helps them to establish the evidence that both parties will need to determine a medicine's benefit-risk balance and value as efficiently as possible. read more >

  • 01-04-2016
ECA - European Compliance Academy

QP Education and Qualification - What is needed?

We are frequently asked about the educational requirements in order to become a Qualified Person in Europe. Comprehensive educational modules are offered, especially in the UK. These training courses contain different topics like pharmaceutical law, Microbiology, Quality Management etc and require the trainee to take part in multiple courses over an extended period. But is this needed to become a QP in Europe? read more >

  • 31-03-2016
PHAGECON

TRAINING COURSE ON GENERICS MASTERING REGULATORY AND DEVELOPMENT STRATEGIES FOR GENERICS (18-19/04/2016)

The growing increase of the volume and complexity of the regulatory requirements regarding Generic Medicinal Products has been a constant in the life of all the Regulatory Affairs professionals. Having identified this gap in the panorama of services provided in Portugal, Phagecon will organise, on the days 18 and 19 April in Lisbon, the training Training course on Generics Mastering Regulatory and Development Strategies for Generics. This training will be given by Andrew Willis, a professional with 30 years of experience in some of the biggest companies of the world and that gives the same training in the reputable PTI (Pharmaceutical Training International). Take advantage of the last seats available in this excellent opportunity. Come enjoy top training in the entire World. To do so just click on the link (http://www.phagecon.pt/files/Training_Course_on_Generics.pdf) and fill the applicable form and send the proof of payment with identification of the company and trainee to the email training@phagecon.pt read more >

  • 30-03-2016
EMA - European Medicines Agency

Reflection paper on assessment of cardiovascular safety profile of medicinal products

Adopted read more >

  • 29-03-2016
EMA - European Medicines Agency

Minutes of the CVMP meeting of 16-18 February 2016

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  • 24-03-2016
ECA - European Compliance Academy

EMA publishes GVP Module V (Revision 2) for public comment

Module V of the Guideline on Good Pharmacovigilance Practice (GVP) has been revised by the European Medicines Agency (EMA). Deadline for Comments is May 31, 2016. Module V covers the topic "Risk Management". read more >

  • 23-03-2016
Diário da República

Ordinance no. 48/2016 National Official Journal no. 57/2016, Series I of 2016-03-22

Determines that the medicinal products meant for the treatment of patients with rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, polyarticular juvenile idiopathic arthritis and plaque psoriasis benefit from an exceptional reimbursement regimen. read more >

  • 22-03-2016
EMA - European Medicines Agency

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 14-17 March 2016

In March, the Pharmacovigilance Risk Assessment Committee (PRAC) concluded one safety review. It also discussed three new safety reviews. For one of these, regarding the cancer medicine Zydelig, the PRAC proposed provisional measures, as a precaution, to protect patients while the medicine is being reviewed. read more >

  • 21-03-2016
EMA - European Medicines Agency

Post-orphan medicinal product designation procedures: guidance for sponsors

The opinions on orphan designation are adopted by the Committee for Orphan Medicinal Products (COMP) at their monthly meetings at the European Medicines Agency (EMA). read more >

  • 18-03-2016
EMA - European Medicines Agency

European Medicines Agency/International Federation for Animal Health Europe info day 2016

European Medicines Agency, London, UK, From: 17-Mar-2016, To: 18-Mar-2016. The info day covers the latest developments in the scientific review, regulation and marketing authorisation procedure. It is an opportunity for professionals to get first-hand information on current developments in the veterinary regulatory scene. Registration open. read more >

  • 17-03-2016
ECA - European Compliance Academy

Already 13 EMA GMP Non-compliance Reports in 2016 published

EudraGMDP is the central database for GMP and GDP compliance. Inspections which have been performed by any of the EU member state inspectorates are published in the database. read more >

  • 16-03-2016
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

Update of the Platform of Management of Accessibility of the Medicinal Product

The ruptures of existences, even though merely transient, of manufacturing or supply of a medicinal product, as well as any disturbance to the normal supply of the market, are a concern of this Authority, being part of its mission to ensure the access of the healthcare professionals and of the citizens to quality, effective and safe medicinal products. read more >

  • 15-03-2016
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

Joint Newsletter no. 2/2016/ACSS/INFARMED/SPMS

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  • 14-03-2016
European Comission

Health-EU Newsletter - Falsified Medicines

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  • 11-03-2016
FDA - Food and Drug Administration

FDA Guideline on Dissolution Testing

The FDA has presented the draft of a revised guideline on dissolution testing for immediate release. Under certain conditions, the tests can now be standardised. read more >

  • 09-03-2016
EMA - European Medicines Agency

PRIME: priority medicines

PRIME is a scheme launched by the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need. This voluntary scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimise development plans and speed up evaluation so these medicines can reach patients earlier. read more >

  • 08-03-2016
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

Runoff deadlines elapsing from the application of the Annual Prices Revision

As disclosed in Newsletter no. 193/CD/8.1.6., of 25/11/2015, the runoff deadline, in the pharmacies, of the packages with the maximum prices previous to those resulting from the annual prices revision of non-generic medicinal products is as follows: 60 working days, counting from 01-01-2016 (up to 28-03-2016). read more >

  • 07-03-2016
EMA - European Medicines Agency

Guidance for the publication of clinical data

The European Medicines Agency (EMA) has published detailed guidance for pharmaceutical companies on the requirements to comply with its policy on the publication of clinical data. read more >

  • 04-03-2016
EMA - European Medicines Agency

ICH guideline S1 - Regulatory notice on changes to core guideline on rodent carcinogenicity testing of pharmaceuticals

Adopted read more >

  • 03-03-2016
Diário da República

Ordinance no. 3206/2016 - National Official Journal no. 43/2016, Series II of 2016-03-02

Establishes dispositions about the reference process of people with reactive tests or infected by the viruses of hepatitis B and C, or with other sexually transmitted infections, coming from services and establishments of the National Health Service (NHS) or from entities that have celebrated agreements with the NHS for the providing of health. read more >

  • 02-03-2016
Diário da República

Ordinance no. 35/2016 - National Official Journal no. 42/2016, Series I of 2016-03-01

Establishes the State reimbursement regimen in the maximum price of the reagents (test strips) for determination of blood glucose, ketonemia and ketonuria and of the needles, syringes, lancets and other medicinal devices for the purpose of self-monitoring of people with diabetes, to beneficiaries of the National Health Services and revokes Ordinance no. 222/2014, of 4 November. read more >

  • 01-03-2016
Ordem dos Farmacêuticos

Government and operators of the medicinal product circuit sign Commitment

The Ministry of Health and the associations representative of the pharmaceutical industry and medical devices, the wholesale distributors and the pharmacies signed a Commitment for the Sustainability and the Development of the National Health Service (NHS) based on four strategical principles: access, innovation and sustainability; rational use of the medicinal product and health products; market supervision; and investigation, development and competitiveness. The agreement negotiated along the last months was signed on 26th February, in a ceremony that had the presence of the President of the Bar of the Portuguese Pharmacists Association. read more >

  • 29-02-2016
Diário da República

Order No. 2935-B/2016 - National Official Journal No. 39/2016, 1st Supplement, Series II of 25-02-2016

Establishes provisions in order to enhance the generalisation of the dematerialised electronic prescription (Paperless Prescription), in the National Health Service, creating specific targets for its realization read more >

  • 26-02-2016
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

Recall of medicinal products manufactured by Farma Mediterrània, S.L.

After the inspection performed by the Spanish Agency to the manufacturer Farma Mediterrània, S.L. (Spain), critical and major non-conformities to the Good Manufacturing Practices have been detected. read more >

  • 25-02-2016
ECA - European Compliance Academy

ICH publishes Training Modules on "ICH Q3D - Elemental Impurities"

The ICH has recently published 7 training modules on the ICH Q3D Guideline "Elemental Impurities". read more >

  • 24-02-2016
EMA - European Medicines Agency

Implementation plan for the introduction of the safety features on the packaging of centrally authorised medicina