PHAGECON

DAILY RELEVANT REGULATORY NEWS


Good manufacturing practice Good manufacturing practice (GMP) describes the minimum standard that a medicines manufacturer must meet in their production processes. The European Medicines Agency (EMA) coordinates inspections to verify compliance with these standards and plays a key role in harmonising GMP activities at European Union (EU) level. Read more 22-09-2021
EMA regular press briefing on COVID-19 The European Medicines Agency (EMA) is holding a fortnightly press briefing to provide an update on EMA's COVID-19 activities. Read more 21-09-2021
Nova edição do Boletim de Farmacovigilância Já está disponível a nova edição do Boletim de Farmacovigilância, Volume 25, n.º 8 de agosto de 2021. Read more 20-09-2021
COVID-19 vaccines and medicines: updates for September 2021 Recent information relating to COVID-19 vaccines and medicines that has been published since the August 2021 issue of Drug Safety Update, up to 9 September 2021. Read more 16-09-2021
Consultation on Amendments on Pharmacovigilance Activities A targeted stakeholder consultation on amendments to Commission Implementing Regulation (EU) 520/2012 (IR) on pharmacovigilance activities has been published on the EC website. Comments and proposals received will be published and considered in the work leading to the revision of the IR. Read more 15-09-2021
Deliberação n.º 956/2021 Cria no INFARMED, na dependência da Direção de Avaliação de Tecnologias de Saúde, a Unidade de Gestão da Avaliação e Acesso de Medicamentos Read more 14-09-2021
Deliberação n.º 946/2021 Alteração do Regulamento das Boas Práticas de distribuição por grosso de medicamentos de uso humano. Read more 13-09-2021
Increase in manufacturing capacity for COVID-19 vaccine from BioNTech/Pfizer EMA’s human medicines committee (CHMP) has approved additional manufacturing sites for the production of Comirnaty, the COVID-19 vaccine developed by BioNTech and Pfizer. Read more 10-09-2021
Final EMA Guideline: Quality Requirements for Combination Products Following a draft version, the EMA has now published the final guideline, which describes what documentation is required on the subject of quality for combination products in order to gain and/or maintain a marketing authorization. Read more 09-09-2021
ICH publishes Guideline Q13 on Continuous Production End of July, the ICH (International Council for Harmonisation) published the long-awaited draft guideline on continuous manufacturing. The ICH had already announced in June 2018 that it was working on a new ICH Guideline on Continuous Manufacturing with the abbreviation Q13. In addition to batch definitions, the document describes three different continuous manufacturing approaches and provides guidance on control strategy and approval issues. Read more 08-09-2021
Comunicado da Agência Europeia de Medicamentos: avaliação de pedido de utilização de dose de reforço da vacina Comirnaty A Agência Europeia de Medicamentos (EMA na sigla em inglês) começou a avaliar um pedido de utilização de uma dose de reforço da vacina Comirnaty em pessoas com 16 anos ou mais, a ser administrada 6 meses após os cidadãos terem completado o seu processo de vacinação primária. Read more 07-09-2021
ECDC and EMA highlight considerations for additional and booster doses of COVID-19 vaccines Based on current evidence, there is no urgent need for the administration of booster doses of vaccines to fully vaccinated individuals in the general population, according to a technical report issued yesterday by the European Centre for Disease Prevention and Control (ECDC). The report also notes that additional doses should already be considered for people with severely weakened immune systems as part of their primary vaccination. Read more 02-09-2021
EMA and FDA update Principles for Parallel Scientific Advice in the Marketing Authorization Process Scientific advice and recommendations from regulatory authorities are usually of great benefit for specific medicines in the development phase. The principles for this have recently been updated by the U.S. and European regulatory authorities. Read here how parallel scientific advice from the EMA and the FDA works and what benefits it brings to the approval process. Read more 01-09-2021
What is Similarity? The EMA published the final reflection paper on "Similarity". The paper shows how statistics should be used in drug development when a comparative assessment of quality attributes (QAs) needs to be made for pre- and post-manufacturing changes, biosimilar development as well as generics´ development. Read more 26-08-2021
Increase in vaccine manufacturing capacity for COVID-19 vaccines from BioNTech / Pfizer and Moderna EMA’s human medicines committee (CHMP) has adopted recommendations that will increase manufacturing capacity and supply of COVID-19 vaccines in the EU. Read more 25-08-2021
FDA Approves First COVID-19 Vaccine Approval Signifies Key Achievement for Public Health Read more 24-08-2021
First monoclonal antibody treatment for COVID-19 approved for use in the UK The Medicines and Healthcare products Regulatory Agency (MHRA) has today given approval for the first monoclonal antibody treatment for the prevention and treatment of COVID-19 in the UK. Read more 20-08-2021
Audit Trail-Deviations in the course of Inspections Klaus Feuerhelm, former GMP inspector at the Regierungspräsidium Tübingen in Germany, has compiled a TOP 3 list of deficiencies from 2020 in computerised systems. Number 1 are deficiencies with regard to the audit trail. Read more 18-08-2021
EMA starts evaluating use of RoActemra in hospitalised adults with severe COVID-19 EMA has started evaluating the anti-inflammatory medicine RoActemra (tocilizumab) to extend its use to include treatment of hospitalised adult patients with severe COVID-19 who are already receiving treatment with corticosteroids and require extra oxygen or mechanical ventilation (breathing assisted by a machine). Read more 17-08-2021
Northern Ireland: EU continues to look for Solutions - with interesting Forms of Documents Have you ever heard of a "non-paper"? That is the name given by the EU Commission to a new document that describes proposed solutions for the practical handling of problems within the framework of the Northern Ireland Protocol. The exact title is "Non-Paper: Medicines and the Implementation of the Protocol on Ireland and Northern Ireland"; it was published on 26 July. Read more 10-08-2021
Human medicines highlights - August 2021 Read more 06-08-2021
Comunicação conjunta EMA e ECDC sobre COVID-19: EMA e ECDC recomendam vacinação em todos os cidadãos elegíveis No segundo comunicado conjunto sobre a vacinação contra a COVID-19, a Agência Europeia de Medicamentos (EMA na sigla em inglês) e o Centro Europeu de Prevenção e Controlo das Doenças (ECDC na sigla em inglês) recomendam a vacinação o mais breve possível contra a COVID-19 de toda a população elegível que ainda não foi vacinada ou não tenha completado o esquema vacinal recomendado. Este comunicado surge na sequência do aumento da circulação da variante Delta do SARS-CoV-2 nos países da UE/EEE. Apenas com esquema vacinal recomendado com qualquer vacina autorizada na UE/EEE será possível proteção elevada contra doença grave, morte por SARS-CoV-2 incluindo variantes, como é o caso da variante Delta. A vacinação é igualmente importante para proteger a população com maior risco de doença grave e hospitalização, mas também para reduzir a disseminação do vírus e, como tal, evitar o surgimento de novas variantes de preocupação e de infeções entre aqueles já vacinados. Read more 05-08-2021
Boas Práticas de Distribuição e Farmacovigilância Foram publicados no Jornal Oficial da União, três atos de execução da CE ao abrigo do Regulamento (UE) 2019/6 do parlamento europeu e do conselho de 11 de dezembro de 2018, relacionados com as Boas Práticas de Distribuição (BPD) e Farmacovigilância. Read more 04-08-2021
Sistema europeu de ensaios clínicos lançado em janeiro A Comissão Europeia (CE) confirmou que a entrada em vigor do Regulamento Europeu de Ensaios Clínicos, bem como o lançamento do Sistema Europeu de Ensaios Clínicos (Clinical Trials Information System - CTIS), acontecerá a 31 de janeiro de 2022, seis meses após publicação no Jornal Oficial da União Europeia. Read more 03-08-2021
Parecer sobre vacinação universal de pessoas entre os 12 e 15 anos A Direção-Geral da Saúde (DGS) solicitou o parecer da Ordem dos Farmacêuticos (OF) sobre a vacinação universal de pessoas entre os 12 e 15 anos contra a COVID-19. Read more 30-07-2021
Novo serviço de alertas de tecnologias de saúde Desenvolvido no âmbito da medida SIMPLEX Comunica + (medida conjunta Infarmed/ACSS), foi hoje lançado um novo serviço de alertas de tecnologias de saúde (SATS) destinado à disponibilização de informação sobre segurança, qualidade e disponibilidade dos medicamentos. Read more 28-07-2021
Relatório de Farmacovigilância: monitorização da segurança das vacinas contra a COVID-19 em Portugal Read more 27-07-2021
Aviso de indisponibilidade de aplicações Informa-se que, por motivos de manutenção, as aplicações CITS, Infomed, INSP+, SIATS e SMUH poderão apresentar períodos de indisponibilidade durante a manhã de 2ª feira (26/7). Read more 23-07-2021
Updated Templates for Reporting Nitrosamine Contamination to Regulatory Authorities Within the framework of the referral procedure according to Art. 5(3) of Regulation (EC) 726/2004 ("Call for Review"), marketing authorisation holders of medicinal products containing chemically synthesissed and biological APIs are requested to perform a confirmatory testing of their products for nitrosamine content (step 2) after a risk of contamination with nitrosamines has been identified in a previous assessment of the manufacturing process (step 1) (see our news on the update of the question and answer document on nitrosamine contamination). Read more 21-07-2021
EMA starts evaluating the use of Kineret in adult COVID-19 patients at increased risk of severe respiratory failure EMA has started evaluating an application to extend the use of Kineret (anakinra) to include treatment of coronavirus disease 2019 (COVID-19) in adult patients with pneumonia who are at risk of developing severe respiratory failure (inability of the lungs to work properly). Read more 20-07-2021
International regulators work towards alignment on development and authorisation of second-generation COVID-19 vaccines Regulatory convergence is critical for expediting and streamlining global development and authorisation of new or modified COVID-19 vaccines to address emerging coronavirus variants. The important role of regulatory alignment is described in the summary of the second workshop on COVID-19 vaccine development and virus variants, organised under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA), which has been published today. Read more 19-07-2021
EMA and ECDC update on COVID-19 Vaccination remains one of the best protective measures against COVID-19. Recommendations for vaccination are in place in all Member States and roll-out of vaccination is ongoing. The European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC) urge EU citizens to get vaccinated and to adhere to the recommended number of doses.1 This is particularly important taking into account the spread of the Delta variant of SARS-CoV-2 (the virus that causes COVID-19), the need to protect citizens, especially those at risk of severe COVID-19, and the desire to open up our societies and relax restrictions. Read more 15-07-2021
Q&A Document on Nitrosamine Impurities Updated At the end of June, the question and answer document of the EMA and the CMDh (Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human) was updated again and published as 4th revision on the EMA news page on 2 July. The updates affect questions 3 and 10 of the document. Read more 14-07-2021
Comirnaty e Spikevax: possível ligação a casos muito raros de miocardite e pericardite A miocardite e a pericardite são doenças inflamatórias do coração que se manifestam geralmente por falta de ar, dor no peito e batimento cardíaco intenso que pode ser irregular (palpitações). São doenças que ocorrem com determinada frequência na população em geral e evoluem geralmente de forma benigna. Read more 12-07-2021
Brexit: EU defines possible Solutions for Northern Ireland The European Commission has published a so-called "balanced package" of measures to address some of the most pressing issues related to the implementation of the Protocol on Ireland and Northern Ireland. With this commitment, the EU tries to find "creative solutions". Read more 07-07-2021
Pharmeuropa 33.3 just released All new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 33.3 is 30 September 2021. Read more 05-07-2021
Nitrosamine impurities The European Medicines Agency (EMA) has assessed the risk of nitrosamine formation or presence during the manufacture of human medicines and has provided guidance to marketing authorisation holders to avoid the presence of nitrosamine impurities. Read more 02-07-2021
Novo Regulamento dos Dispositivos Médicos: ficha informativa para mandatários, importadores e distribuidores Consulte a infografia. Read more 30-06-2021
EMA publishes Q&A Document about Parallel Distribution Parallel distribution is defined as the distribution of a centrally authorised medicinal product from one Member State to another by a pharmaceutical company independent of the marketing authorisation holder. Centrally authorised products are marketed in all Member States under the same name and must comply with the Community Marketing Authorisation. Read more 29-06-2021
First cell-based gene therapy to treat adult patients with multiple myeloma EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Abecma (idecabtagene vicleucel) for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three previous therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and whose cancer has worsened since receiving the last treatment. Read more 28-06-2021
Aplicação do Regulamento dos Dispositivos Médicos (RDM) na parte que se refere à investigação clínica de dispositivos O Regulamento Europeu dos Dispositivos Médicos (RDM)1 relativo aos dispositivos médicos tornou-se aplicável a 26 de maio de 2021, revogando as Diretivas 90/385/CEE e 93/42/CEE, sem necessidade de proceder à sua transposição para o ordenamento jurídico nacional. Read more 25-06-2021
Novo Regulamento dos Dispositivos Médicos: ficha informativa para fabricantes Consulte a infografia. Read more 23-06-2021
Novo Regulamento dos Dispositivos Médicos: modelo para a implementação, passo a passo Consulte o guia passo a passo. Read more 17-06-2021
Ph. Eur. General Notices Chapter - New Structure and Content The European Pharmacopoeia (Ph. Eur.) Commission adopted a revised version of Ph. Eur. chapter 1. General Notices to provide greater clarity for users. Read more 16-06-2021
COVID-19 vaccines: update on ongoing evaluation of myocarditis and pericarditis EMA’s safety committee (PRAC) is continuing its assessment of reports of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the membrane around the heart) in a small number of people following vaccination with COVID-19 vaccines. Read more 14-06-2021
International regulators and WHO address need to boost COVID-19 vaccine confidence The International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO) have jointly developed a statement to help healthcare professionals increase trust and confidence in COVID-19 vaccines and answer questions from patients about the development, regulatory review and safety monitoring of these vaccines. Read more 11-06-2021
Novo Regulamento dos Dispositivos Médicos: novas características Read more 09-06-2021
EMA raises awareness of clinical care recommendations to manage suspected thrombosis with thrombocytopenia syndrome EMA’s COVID-19 taskforce (COVID-ETF) is advising healthcare professionals in the EU to consider recommendations by learned societies when assessing people with signs and symptoms of thrombosis with thrombocytopenia syndrome (TTS) following vaccination with Vaxzevria and COVID-19 Vaccine Janssen. In this context it is highlighting guidance from the International Society on Thrombosis and Haemostasis (ISTH). Read more 08-06-2021
Relatório: Vacinas para a COVID-19 - Reações adversas em Portugal Read more 07-06-2021
Novo Regulamento dos Dispositivos Médicos: está preparado? Consulte a infografia com o calendário de transição das diretivas. Read more 04-06-2021
The GMP Requirements for Supplier Qualification Supplier Qualification is more than auditing. Supplier qualification can be seen as a risk assessment tool. But what are the exact requirements? Read more 02-06-2021
Questions & Answers on Good Distribution Practices (GDP) - Part 4 In October 2020, the ECA offered the Live Online Training "The GDP Compliance Manager". During the Q&A sessions, many interesting questions were posed to the speakers' team. The ECA would like to share a selection of these Q&As sorted by topic. Read more 01-06-2021
First COVID-19 vaccine approved for children aged 12 to 15 in EU EMA’s human medicines committee (CHMP) has recommended granting an extension of indication for the COVID-19 vaccine Comirnaty to include use in children aged 12 to 15. The vaccine is already approved for use in adults and adolescents aged 16 and above. Read more 31-05-2021
Insufficient data on use of inhaled corticosteroids to treat COVID-19 EMA’s COVID-19 taskforce (COVID-ETF)1 is advising healthcare professionals that there is currently insufficient evidence that inhaled corticosteroids are beneficial for people with COVID-19. Read more 28-05-2021
Comunicado de Imprensa - Novo Regulamento Europeu dos Dispositivos Médicos O novo Regulamento representa uma atualização significativa das diretivas existentes sobre dispositivos médicos, que estão em vigor há 30 anos. Tem como objetivo fortalecer e melhorar o sistema regulamentardosdispositivos médicos na Europa, de forma a garantir que os dispositivos médicos sejam seguros e funcionem conforme planeado ao longo do seu tempo de vida. Visa também assegurar que a inovação e o desenvolvimento de novas tecnologias são promovidosa nível europeu para proporcionarem aos doentes e aos sistemas de saúde novas opções terapêuticas e de diagnóstico. Read more 27-05-2021
APIC: Update of the Template for Potential Nitrosamine Contaminations The latest version of the "REPORT ON THE RISK OF POTENTIAL PRESENCE OF NITROSAMINE IMPURITIES" has been available on the APIC website since April 2021. The questionnaire is to be seen as a summary report and can be used to document the results of risk assessments with regard to contamination by nitrosamines in APIs. It needs to be completed for one API at a time and complies with the applicable requirements for risk assessment in the field of nitrosamines as specified by the regulatory authorities. Read more 26-05-2021
Vaxzevria: Recomendações adicionais relativamente à ocorrência muito rara de coágulos sanguíneos invulgares com diminuição do nível de plaquetas (síndroma de trombose e trombocitopenia, TTS) A Agência Europeia de Medicamentos (EMAna sigla em inglês) efetuou recomendações adicionais relativamente à ocorrência muito rara de formação de coágulos sanguíneos invulgares associados a um nível baixo de plaquetas (trombocitopenia) após vacinação com Vaxzevria (anteriormente denominada vacina contra a COVID-19 da AstraZeneca). Read more 25-05-2021
First gene therapy to treat children with rare inherited neurological disease EMA has recommended granting a marketing authorisation in the European Union for the gene therapy Skysona (elivaldogene autotemcel) for the treatment of children with cerebral adrenoleukodystrophy (CALD), a severe form of a rare inherited neurological disease. This disease, seen almost exclusively in males, affects the brain and leads to an irreversible loss of neurological functions. Read more 24-05-2021
EMA procedural advice for medicinal products intended exclusively for markets outside the European Union in the context of co-operation with the World Health Organisation (WHO) Read more 21-05-2021
GMP: Are there "planned" Deviations? One discussion we have again and again in seminars is the question of planned variations. But such terminology can lead to problems. Read more 19-05-2021
Notice to manufacturers and authorised representatives on the impact of genetic variants on SARS-COV-2 in vitro diagnostic medical devices Read more 18-05-2021
CMDh practical guidance for Marketing Authorisation Holders of nationally authorised products (incl. MRP/DCP) in relation to the Art. 5(3) Referral on Nitrosamines Read more 13-05-2021
MHRA establishes own GMDP Database EudraGMDP is a GMP and GDP related database of the European Community containing manufacturing and wholesale authorisations, GMP certificates and non-Compliance Reports published in the EudraGMDP database. These reports are generated by the competent authorities, which conduct GMP inspections at the premises and upload their reports into the database. In 2019, Swissmedic has begun to enter information on GMP inspections and manufacturing authorisations for Swiss manufacturers into the database. Read more 12-05-2021
Revised monograph Water for injections published for public comment in Pharmeuropa The revised general monograph Water for injections (0169) has been published in this quarter’s issue of Pharmeuropa (33.2), the European Pharmacopeia (Ph. Eur.) online forum, for comment. The text has been revised to delete the tests for inorganic substances from the section on Sterilised water for injection. Read more 11-05-2021
Vacinas para a COVID-19: Relatório sobre reações adversas em Portugal O Infarmed disponibiliza, desde abril, para consulta no seu site (na área COVID-19/Vacinas), um relatório sobre as reações adversas notificadas às vacinas para a COVID-19. Read more 10-05-2021
International regulators and WHO call for wider public access to clinical data The International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO) are urging pharmaceutical companies to publish clinical trial reports for new medicines and vaccines without redactions to ensure that research results are publicly accessible to all those involved in healthcare decision-making. In a joint statement, they stress that systematic transparency can increase trust in regulatory decision-making, reassure the public about data integrity and can stimulate research and development, which could have a positive impact on vaccine confidence. Read more 07-05-2021
Revision of the PIC/S Guidelines for ATMPs and Biological Medicinal Products Especially in the field of biological agents and medicinal products and in ATMPs, developments are progressing rapidly. The development of vaccines in the context of the Corona pandemic has clearly shown this. This necessarily also has an impact on the relevant guidelines. Read more 06-05-2021
EMA starts rolling review of COVID-19 Vaccine (Vero Cell) Inactivated EMA’s human medicines committee (CHMP) has started a rolling review of COVID-19 Vaccine (Vero Cell) Inactivated, developed by Sinovac Life Sciences Co., Ltd. The EU applicant for this medicine is Life'On S.r.l. Read more 05-05-2021
EMA starts evaluating use of COVID-19 vaccine Comirnaty in young people aged 12 to 15 EMA has started evaluating an application to extend the use of the COVID-19 vaccine Comirnaty to include young people aged 12 to 15. Read more 04-05-2021
A new collaboration between SNOMED International and ICH promotes seamless data exchange in support of public health SNOMED International and ICH are announcing the release of important new maps between global medical terminologies SNOMED CT and MedDRA. Read more 30-04-2021
Factsheet for Class I - Medical Devices Read more 29-04-2021
Unidade de Farmacovigilância de Braga inicia atividades O Sistema Nacional de Farmacovigilância conta agora com um nova Unidade Regional de Farmacovigilância (URF), em Braga. Esta unidade, que iniciou a sua atividade este mês, está sediada no Hospital de Braga e será responsável pelo tratamento das notificações de Reação Adversas a Medicamentos (RAM) ocorridas nos distritos de Vila Real, Bragança e nos concelhos de Amares, Barcelos, Braga, Vieira do Minho, Vila Verde, Esposende, Póvoa de Lanhoso, Terras de Bouro e Vila Nova de Famalicão, pertencentes ao distrito de Braga, correspondendo a uma população de cerca de 912mil pessoas e mais de 4000 profissionais de saúde. Read more 28-04-2021
Questions & Answers on Good Distribution Practices (GDP) - Part 3 In October 2020, the ECA offered the Live Online Training "The GDP Compliance Manager". During the Q&A sessions, many interesting questions were posed to the speakers' team. The ECA would like to share a selection of these Q&As sorted by topic. Read more 27-04-2021
Banco Farmacêutico apela à doação de medicamentos Realiza-se dia 24 de abril, a XIII Jornada de Recolha de Medicamentos organizada anualmente pelo Banco Farmacêutico. Mais de 150 farmácias em todo o país vão apelar à doação de medicamentos não sujeitos a receita médica e outros produtos de saúde destinados a utentes de mais de 120 instituições particulares de solidariedade social. A pandemia de COVID-19 impede a participação de centenas de voluntários na jornada deste ano, mas a organização espera também que impulsione a generosidade dos portugueses para apoiar as populações mais carenciadas num período particularmente difícil. Read more 26-04-2021
COVID-19 Vaccine Janssen: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets At its meeting of 20 April 2021, EMA’s safety committee (PRAC) concluded that a warning about unusual blood clots with low blood platelets should be added to the product information for COVID-19 Vaccine Janssen. PRAC also concluded that these events should be listed as very rare side effects of the vaccine. Read more 21-04-2021
The Draft Principles of ICH E6 Good Clinical Practice (GCP) now available The ICH E6 Good Clinical Practice (GCP) Guideline is widely used by clinical trial researchers beyond the membership and regional representation of ICH itself and has a significant impact on trial participants and patients. Acknowledging the wide and substantial impact of ICH E6, the ICH Management Committee is making available a draft, work-in-progress version of the updated principles that are currently under development by the ICH E6(R3) Expert Working Group (EWG). The principles are interdependent and should be considered in their totality to assure ethical trial conduct, participant safety, and reliable results of clinical trials. Read more 20-04-2021
EMA starts review of VIR-7831 for treating patients with COVID-19 EMA is reviewing currently available data on the use of the monoclonal antibody VIR-7831 (also known as GSK4182136) in the treatment of patients with COVID-19. EMA is starting this review to support national authorities who may decide on the use of this medicine for COVID-19 prior to marketing authorisation. Read more 16-04-2021
COVID-19 Vaccine Janssen: assessment of very rare cases of unusual blood clots with low platelets continues As announced last week, EMA’s safety committee (PRAC) is reviewing very rare cases of unusual blood clots that occurred in the United States following the use of Janssen’s COVID-19 vaccine. The type of blood clot reported, cerebral venous sinus thrombosis (CVST), occurred in most cases in combination with low levels of blood platelets (thrombocytopenia). Read more 15-04-2021
Vaxzevria (previously COVID-19 Vaccine AstraZeneca): link between the vaccine and the occurrence of thrombosis in combination with thrombocytopenia Read more 13-04-2021
Pharmeuropa 33.2 just released All new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 33.2 is 30 June 2021. Read more 09-04-2021
AstraZeneca’s COVID-19 vaccine: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets EMA’s safety committee (PRAC) has concluded today that unusual blood clots with low blood platelets should be listed as very rare side effects of Vaxzevria (formerly COVID-19 Vaccine AstraZeneca). Read more 08-04-2021
EMA: Revision of Q&A Documents regarding the Centralised Procedure Again, two of the Q&A documents relating to the "centralised procedure" have been updated and published on the website of the European Medicines Agency (EMA) in March 2021. The documents are the "European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure" and the "European Medicines Agency post-authorisation procedural advice for users of the centralised procedure", which refer to pre-authorisation as well as post-authorisation questions. The latest versions of these two sets of questions have each been supplemented by a question regarding the importation of finished medicinal products into the European Union. Read more 07-04-2021
AstraZeneca COVID-19 vaccine: review of very rare cases of unusual blood clots continues EMA’s safety committee (PRAC) is meeting today, Wednesday 31 March, in the context of its ongoing review of very rare cases of unusual blood clots associated with low numbers of platelets, in people vaccinated with AstraZeneca’s COVID-19 vaccine (now called Vaxzevria). Read more 01-04-2021
Rapid Revision and Implementation of Pharmacopoeial Monographs Concerning 5 Sartan Preparations Following the publication of the Assessment Report "Nitrosamine impurities in human medicinal products" by the CHMP on 9 July 2020, the decision was made to directly apply the recommendations on the management of nitrosamine impurities outlined in this report to sartan preparations (angiotensin II receptor antagonists with a tetrazole ring). Read more 31-03-2021
Increase in vaccine manufacturing capacity and supply for COVID-19 vaccines from AstraZeneca, BioNTech/Pfizer and Moderna EMA’s human medicines committee (CHMP) has adopted several important recommendations that will increase manufacturing capacity and supply of COVID-19 vaccines in the EU. Read more 29-03-2021
COVID-19 Vaccine AstraZeneca – Update on ongoing evaluation of blood clot cases Last week, EMA’s safety committee, PRAC, concluded its preliminary review of cases of blood clots, including very rare cases of blood clots with unusual features such as low numbers of platelets, in people vaccinated with COVID-19 Vaccine AstraZeneca. The committee confirmed that the vaccine is not associated with an increase in the overall risk of blood clots and that the benefits of the vaccine in combating the still widespread threat of COVID-19 continue to outweigh the risk of side effects. The committee recommended including more information and advice for healthcare professionals and the public in the vaccine’s product information. Read more 26-03-2021
Brexit: Pharmacovigilance Requirements for UK MAHs Following the Brexit, the MHRA posted an updated guidance to become familiar with the pharmacovigilance requirements for UK marketing authorization holders (MAHs). Read more 24-03-2021
EMA advises against use of ivermectin for the prevention or treatment of COVID-19 outside randomised clinical trials EMA has reviewed the latest evidence on the use of ivermectin for the prevention and treatment of COVID-19 and concluded that the available data do not support its use for COVID-19 outside well-designed clinical trials. Read more 23-03-2021
COVID-19 Vaccine AstraZeneca: benefits still outweigh the risks despite possible link to rare blood clots with low blood platelets EMA’s safety committee, PRAC, concluded its preliminary review of a signal of blood clots in people vaccinated with COVID-19 Vaccine AstraZeneca at its extraordinary meeting of 18 March 2021. Read more 19-03-2021
Coronavirus: Commission proposes a Digital Green Certificate Read more 18-03-2021
Investigation of COVID-19 Vaccine AstraZeneca and thromboembolic events continues EMA’s safety committee (PRAC) made further progress today, Tuesday 16 March, in its detailed evaluation of cases of blood clots, some with unusual features such as low numbers of platelets, in recipients of COVID-19 Vaccine AstraZeneca. As previously stated, while its investigation is ongoing, EMA currently remains of the view that the benefits of the AstraZeneca vaccine in preventing COVID-19, with its associated risk of hospitalisation and death, outweigh the risks of side effects. Read more 17-03-2021
EMA’s safety committee continues investigation of COVID-19 Vaccine AstraZeneca and thromboembolic events – further update Several authorities responsible for national vaccine campaigns in EU countries have temporarily paused vaccination with COVID-19 Vaccine AstraZeneca. This is a precaution taken in the light of their national situation while EMA investigates a number of events of blood clots in people who had received the vaccine, as previously reported. Read more 16-03-2021
Esclarecimento da Direção-Geral da Saúde e do INFARMED, I.P. face à ação das autoridades dinamarquesas, norueguesas e islandesas de suspender temporariamente a vacinação com a vacina contra a COVID-19 da AstraZeneca A decisão, por parte das autoridades dinamarquesas, norueguesas e islandesas de suspensão temporária da vacinação com a vacina da AstraZeneca foi uma medida de precaução. Não foi confirmado que os eventos tromboembólicos notificados tenham sido causados por esta vacina. As pessoas podem ser vacinadas de acordo com o agendamento efetuado. Read more 15-03-2021
EMA recommends COVID-19 Vaccine Janssen for authorisation in the EU Read more 12-03-2021
Vacina contra a COVID-19 AstraZeneca: resultados preliminares não sugerem problema específico com o lote usado na Áustria Na sequência da informação relativa à suspensão, pela Autoridade Competente Austríaca, da utilização do lote ABV5300 da vacina contra a COVID-19 da AstraZeneca (ver Nota Informativa de 07/03/2021), o Comité de Avaliação do Risco em Farmacovigilância (PRAC) da Agência Europeia de Medicamento (EMA na sigla em inglês) encontra-se a avaliar os casos de eventos tromboembólicos notificados que ocorreram após administração desta vacina. A informação disponível, até ao momento, indica que o número de eventos tromboembólicos em pessoas vacinadas não é superior ao observado na população em geral. Read more 11-03-2021
CMDh practical guidance for Marketing Authorisation Holders of nationally authorised products (incl. MRP/DCP) in relation to the Art. 5(3) Referral on Nitrosamines Read more 09-03-2021
Suspensão da AIM de medicamentos contendo ranitidina Conforme divulgado na Circular informativa n.º 143/CD/550.20.001 de 20/09/2019 e na Circular informativa nº 171/CD/550.20.001 de 08/11/2020, o Infarmed recomendou a recolha e suspensão imediata da comercialização dos lotes de medicamentos com ranitidina. Read more 08-03-2021
Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP Read more 05-03-2021
EMA starts rolling review of the Sputnik V COVID-19 vaccine EMA’s human medicines committee (CHMP) has started a rolling review of Sputnik V (Gam-COVID-Vac), a COVID-19 vaccine1 developed by Russia’s Gamaleya National Centre of Epidemiology and Microbiology. The EU applicant for this medicine is R-Pharm Germany GmbH. Read more 04-03-2021
EMA Guidance on Adjusting Vaccines to COVID-19 Variants Currently, the increasing emergence of new SARS-CoV2 variants is presenting new challenges to medicine, health authorities and also vaccine manufacturers. On 22 February, the FDA, as the relevant US-American authority, published a series of appropriately amended guidance documents containing recommendations for the developers and manufacturers of COVID-19 vaccines. Read more 03-03-2021
First oral treatment for spinal muscular atrophy (SMA) recommended for approval EMA has recommended granting a marketing authorisation in the European Union for the first treatment that can be given orally to patients with certain types of spinal muscular atrophy (SMA), a rare and often fatal genetic disease that causes muscle weakness and progressive loss of movement. Read more 01-03-2021
International cooperation to align approaches for regulation of COVID-19 vaccines and medicines Regulators around the globe are committed to aligning their regulatory requirements and addressing knowledge gaps to facilitate the development, authorisation and monitoring of safe, effective and high-quality vaccines and medicines against COVID-19. This was highlighted in a series of regulatory workshops, convened under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA) in the first weeks of 2021, which focused on three areas: responding to emerging COVID-19 virus variants, addressing knowledge gaps regarding COVID-19 vaccines and treatments in pregnant and breastfeeding women, and strengthening collaboration on safety monitoring of vaccines. Read more 26-02-2021
EMA starts rolling review of Celltrion antibody regdanvimab for COVID-19 EMA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on the monoclonal antibody regdanvimab (also known as CT-P59), which is being developed by Celltrion, for the treatment of COVID-19. Read more 25-02-2021
Brexit: Pharmacovigilance Requirements for UK MAHs Following the Brexit, the MHRA posted an updated guidance to become familiar with the pharmacovigilance requirements for UK marketing authorization holders (MAHs). Read more 24-02-2021
EMA starts evaluating use of Veklury in COVID-19 patients not requiring supplemental oxygen EMA has started evaluating an application to extend the use of Veklury (remdesivir) to include treating adults with COVID-19 who do not require supplemental oxygen. Read more 23-02-2021
European Medicines Regulatory Network approach for the implementation of the CHMP Opinion pursuant to Article 5(3) of Regulation (EC) No 726/2004 for nitrosamine impurities in human medicines Read more 22-02-2021
Coronavirus: preparing Europe for the increased threat of variants Read more 18-02-2021
Brexit Guideline from CMDh updated The Heads of Medicines Agencies (HMA) consists of the heads of the National Competent (EU) Authorities who are responsible for the regulation of medicinal products in the EU. The Co-ordination Group for Mutual Recognition and Decentralised procedures - Human (CMDh) of the HMA has updated a recently published Guideline on Brexit. Read more 17-02-2021
EMA starts rolling review of CureVac’s COVID-19 vaccine (CVnCoV) Read more 12-02-2021
EMA preparing guidance to tackle COVID-19 variants Read more 11-02-2021
COVID-19 vaccine safety update for COVID-19 Vaccine Moderna: February 2021 Read more 08-02-2021
Modern Vaccines and Platform Technologies - Explained in an Understandable Way In the current situation, we receive a variety of questions about the current vaccine development, vaccine types, licensure and more. Read more 05-02-2021
EMA starts rolling review of Novavax’s COVID-19 vaccine (NVX-CoV2373) EMA’s human medicines committee (CHMP) has started a rolling review of NVX-CoV2373, a COVID 19 vaccine being developed by Novavax CZ AS (a subsidiary of Novavax, Inc.). Read more 04-02-2021
New EU Commission Brexit Notice on Medicinal Products The EU Commission published a new notice in the Official Journal of the EU on 25 January 2021 entitled "Application of the Union’s pharmaceutical acquis in markets historically dependent on medicines supply from or through Great Britain after the end of the transition period 2021/C 27/08)". Read more 03-02-2021
EMA starts rolling review of REGN-COV2 antibody combination (casirivimab / imdevimab) EMA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on a medicine known as REGN-COV2 antibody combination (casirivimab / imdevimab), which is being co-developed by Regeneron Pharmaceuticals, Inc. and F. Hoffman-La Roche, Ltd (Roche) for the treatment and prevention of COVID-19. Read more 02-02-2021
EMA recommends COVID-19 Vaccine AstraZeneca for authorisation in the EU EMA has recommended granting a conditional marketing authorisation for COVID-19 Vaccine AstraZeneca to prevent coronavirus disease 2019 (COVID-19) in people from 18 years of age. This is the third COVID-19 vaccine that EMA has recommended for authorisation. Read more 01-02-2021
First COVID-19 vaccine safety update published Today EMA has released its first safety update on a COVID-19 vaccine — Comirnaty. It concludes that safety data collected on Comirnaty use in vaccination campaigns is consistent with the known safety profile of the vaccine, and no new side effects were identified. Read more 29-01-2021
Rastreabilidade de stocks de medicamentos para COVID-19 Em sequência das circulares informativas do Infarmed n.º 062/CD/100.20.200, de 05/03/2020, e n.º 068/CD/100.20.200, de 13/03/2020, sobre o assunto em epígrafe, o Infarmed vem recordar da importância para a monitorização rigorosa dos stocks dos medicamentos incluídos no Despacho n.º 8057/2020, de 19 de agosto, o qual estabelece o reforço de stocks de medicamentos e diversos equipamentos médicos e da reserva estratégica nacional, no âmbito da pandemia COVID-19. Read more 26-01-2021
COVID-19 and vaccines: Equitable access to vaccination must be ensured How can we ensure equitable access to vaccination during the current and future pandemics? The Council of Europe Committee on Bioethics has made today a number of recommendations. Read more 25-01-2021
Public-health advice during COVID-19 pandemic The European Medicines Agency (EMA) is providing impartial advice to patients and healthcare professionals on the safe use of medicines during the COVID-19 pandemic, in particular in patients with or at risk of COVID-19 infection. Read more 21-01-2021
Global regulators highlight key role of healthcare professionals in fostering confidence in COVID-19 vaccines EMA has endorsed a joint statement published today by the International Coalition of Medicines Regulatory Authorities (ICMRA) to inform and help healthcare professionals answer questions about the evaluation, approval and monitoring of safe, effective and high-quality COVID-19 vaccines. Read more 20-01-2021
National competent authorities (human) The European Medicines Agency works closely with the national competent authorities of the Member States of the European Union (EU) and the European Economic Area (EEA) responsible for human medicines. Read more 15-01-2021
Brexit Agreement - what now? After intensive negotiations, the European Union (EU) and the United Kingdom (UK) agreed on a provisional Trade and Cooperation Agreement on 24 December 2020. By the end of the year, all remaining EU member states have given their consent to the agreement and its provisional application. For the agreement to finally enter into force, the approval of the European Parliament is still required. Read more 13-01-2021
EMA receives application for conditional marketing authorisation of COVID-19 Vaccine AstraZeneca EMA has received an application for conditional marketing authorisation (CMA) for a COVID-19 vaccine developed by AstraZeneca and Oxford University. The assessment of the vaccine, known as COVID-19 Vaccine AstraZeneca, will proceed under an accelerated timeline. An opinion on the marketing authorisation could be issued by 29 January during the meeting of EMA’s scientific committee for human medicines (CHMP), provided that the data submitted on the quality, safety and efficacy of the vaccine are sufficiently robust and complete and that any additional information required to complete the assessment is promptly submitted. Read more 12-01-2021
Extra dose from vials of Comirnaty COVID-19 vaccine EMA’s human medicines committee (CHMP) has recommended updating the PDF iconproduct information for Comirnaty to clarify that each vial contains 6 doses of the vaccine. Read more 11-01-2021
EMA recommends COVID-19 Vaccine Moderna for authorisation in the EU EMA has recommended granting a conditional marketing authorisation for COVID-19 Vaccine Moderna to prevent Coronavirus disease (COVID-19) in people from 18 years of age. This is the second COVID-19 vaccine that EMA has recommended for authorisation. Read more 07-01-2021
Brexit: the United Kingdom's withdrawal from the European Union The United Kingdom (UK) formally left the European Union (EU) on 31 January 2020 and became a third country. During a transition period from 1 February to 31 December 2020, EU pharmaceutical law continued to apply to the UK. From 1 January 2021, EU pharmaceutical law applies to the UK in respect of Northern Ireland only. Read more 04-01-2021
EMA organises a second public meeting about the new COVID-19 vaccines EMA will organise a second public meeting on 8 January 2021 to inform European citizens about the assessment, approval and roll-out of new COVID-19 vaccines. Read more 23-12-2020
European Commission authorises first safe and effective vaccine against COVID-19 Read more 22-12-2020
EMA Management Board: highlights of December 2020 meeting The December 2020 meeting of the Management Board was Emer Cooke’s first Board meeting as EMA's Executive Director since she took up leadership of EMA in November. Read more 21-12-2020
Update on assessment of marketing authorisation application for Moderna’s mRNA-1273 COVID-19 vaccine Over the last few weeks, EMA has made good progress on the assessment of the marketing authorisation application for Moderna’s mRNA-1273 COVID-19 vaccine. A continuous dialogue with the company has ensured that questions that arose during the evaluation were swiftly followed up and addressed by the company. Read more 18-12-2020
Update on assessment of the BioNTech and Pfizer BNT162b2 vaccine marketing authorisation application EMA’s human medicines committee (CHMP) and its experts have been working intensively over the past weeks to evaluate data submitted by BioNTech and Pfizer in the context of the conditional marketing authorisation (CMA) application for BNT162b2, a COVID 19 mRNA vaccine. Read more 16-12-2020
Comissão Europeia disponibiliza Q&A sobre vacinas COVID-19 A Comissão Europeia publicou no seu site uma área de Perguntas e Respostas sobre o processo de autorização condicional de introdução no mercado das vacinas COVID-19. Read more 15-12-2020
COVID-19 vaccines: studies for approval The European Medicines Agency (EMA) needs many detailed studies to confirm that a vaccine is safe, provides adequate protection and is of suitable quality. As a public-health body safeguarding medicines in the European Union (EU), EMA will only approve a vaccine for COVID-19 after a thorough evalutation demonstrating the same high standards of quality, safety and efficacy required for any other vaccine approved in the EU. Read more 14-12-2020
infoDM em vídeo: nova ferramenta de pesquisa pública de dispositivos médicos Já conhece a nova ferramenta de pesquisa pública dos dispositivos médicos registados no Infarmed? Através dela poderá saber quais os dispositivos médicos disponíveis no mercado e as suas caraterísticas. Read more 10-12-2020
Estratégia conjunta prepara futuro da rede de agências reguladoras de medicamentos da UE até 2025 Como uma das agências que fazem parte desta rede de excelência, o Infarmed comunica que a Agência Europeia de Medicamentos (EMA, na sigla em inglês) e os Chefes das Agências de Medicamentos (HMA, na sigla em inglês) publicaram a sua estratégia conjunta para os próximos cinco anos. Read more 09-12-2020
EMA publica orientações sobre flexibilização quanto à informação do medicamento (Folheto Informativo e Rotulagem) para as vacinas contra a COVID-19 No âmbito das medidas de flexibilidade quanto à rotulagem e embalagem das vacinas contra a COVID-19, o Infarmed informa que a Agência Europeia de Medicamentos (EMA na sigla em inglês) publicou o documento Questions and answers on labelling flexibilities for COVID19 vaccines , com orientações sobre a forma como poderá ser agilizado o desenvolvimento das vacinas no que diz respeito à informação do medicamento nomeadamente Folheto Informativo e Rotulagem, permitindo uma distribuição rápida e em larga escala na União Europeia. Read more 07-12-2020
Coronavirus: Commission presents “Staying safe from COVID-19 during winter” strategy Read more 03-12-2020
EMA receives application for conditional marketing authorisation of COVID-19 mRNA vaccine BNT162b2 EMA has received an application for conditional marketing authorisation (CMA) for BNT162b2, a COVID 19 mRNA vaccine developed by BioNTech and Pfizer. The assessment of BNT162b2 will proceed under an accelerated timeline. An opinion on the marketing authorisation could be issued within weeks, depending on whether the data submitted are sufficiently robust and complete to show the quality, safety and effectiveness of the vaccine. Read more 02-12-2020
EMA - Public Meeting on COVID-19 Vaccines No other topic is currently as controversial as the research, approval and production of vaccines for COVID-19. The discussion about the necessity, side effects of vaccinations, etc. has been going on for a long time. Due to the accelerated procedures in relation with the Corona pandemic and the uncertainty in the population, these discussions, fueled by a large number of comments and articles in the social media and demonstrations by opponents of the vaccination, have greatly increased. Read more 25-11-2020
Update on remdesivir - EMA will evaluate new data from Solidarity trial EMA is aware that the World Health Organization (WHO) has updated its guidelines advising against the use of remdesivir in hospitalised patients with COVID-19, regardless of disease severity based on a recent meta-analysis. Read more 23-11-2020
EMA publica documento sobre critérios de desenvolvimento e avaliação clínica das vacinas contra a COVID-19 No âmbito da avaliação das vacinas contra a COVID-19, e tendo em conta a necessidade de atualização face aos mais recentes desenvolvimentos nesta área, o Infarmed vem pelo presente comunicar que a Agência Europeia de Medicamentos (EMA na sigla em inglês), publicou o documento "EMA considerations on Covid-19 vaccine approval", onde são apresentados os critérios base aplicáveis ao desenvolvimento e avaliação dos dados clínicos para aprovação das vacinas contra a COVID-19. Read more 20-11-2020
Coronavirus: Commission steps up actions on testing with a recommendation on rapid antigen tests and support to increase testing capacity Read more 19-11-2020
Antimicrobial resistance The emerging and steady increase of microbes that are resistant to antimicrobial treatments has become a global public health concern that threatens the effective treatment of infectious diseases. Combatting this threat, particularly resistance to antibiotics, is a high priority for the European Medicines Agency (EMA) and the European medicines regulatory network. Read more 18-11-2020
EMA starts rolling review of mRNA COVID-19 vaccine by Moderna Biotech Spain, S.L. EMA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on a vaccine for COVID-19 known as mRNA-1273, which is being developed by Moderna Biotech Spain, S.L. (a subsidiary of Moderna, Inc.). Read more 17-11-2020
Nitrosamines: EMA aligns recommendations for sartans with those for other medicines EMA’s human medicines committee (CHMP) has aligned recommendations for limiting nitrosamine impurities in sartan medicines with recent recommendations it issued for other classes of medicines. Read more 16-11-2020
COVID-19 vaccines: release of guidelines critical for co-ordinated independent batch control by EU OMCLs The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published three new Official Control Authority Batch Release (OCABR) guidelines outlining the tests to be performed by Official Medicines Control Laboratories (OMCLs) in the EU OCABR Network as part of the independent control of pandemic COVID-19 vaccine batches. They were adopted by the full OCABR Network and are in force from 12 November 2020. Read more 13-11-2020
Consulte a nova infografia sobre o SIDM Sistema de Informação para Dispositivos Médicos (SIDM), desenvolvido no âmbito do programa SIMPLEX, foi lançado a 2 de novembro de 2020. Read more 10-11-2020
International regulators and WHO join forces to address COVID-19 challenges Read more 09-11-2020
Novo Sistema de Informação para Dispositivos Médicos (SIDM): assista ao vídeo O Novo Sistema de Informação para Dispositivos Médicos (SIDM), que foi lançado no 2 de novembro, apresenta-se agora em vídeo onde se podem ver destacadas as suas principais funcionalidades e o que de novo este sistema de informação oferece aos seus utilizadores. Read more 06-11-2020
Novo sistema de informação para dispositivos médicos O Infarmed desenvolveu um novo Sistema de Informação para Dispositivos Médicos (SIDM) para facilitar e promover o registo de dispositivos médicos pelos operadores e aumentar a transparência do processo, tornando pública toda a informação de registo residente na autoridade reguladora. Read more 05-11-2020
Labelling and Packaging Flexibilities for Covid-19 Vaccines The European Commission (EC) recently published labelling and packaging flexibilities for COVID-19 vaccines. According to the EC, "flexibility in the labelling and packaging requirements can facilitate the rapid deployment of the vaccine by increasing production capacity, reducing transport costs and storage space, and improving the distribution of the doses between Member States". Read more 04-11-2020
Extra transparency measures for COVID-19 vaccines and therapeutics The European Medicines Agency (EMA) has implemented two further extra transparency measures for COVID-19 medicines, by publishing both the clinical data in support of the authorisation of Veklury (remdesivir) and information on the COVID-19 treatments and vaccines that have received scientific advice or informal guidance from EMA’s pandemic Task Force (COVID-ETF). Read more 02-11-2020
Pharmacovigilance Legislation Read more 28-10-2020
PRAC recommendations on safety signals Each month, the European Medicines Agency publishes an overview listing all safety signals discussed during the latest Pharmacovigilance Risk Assessment Committee (PRAC) meeting and the recommendations given for each of them. The overview includes PRAC recommendations for centrally and nationally authorised medicines. Read more 27-10-2020
Strengthening global collaboration on COVID-19 real-world evidence and observational studies Read more 26-10-2020
Novo Sistema de Informação para Dispositivos Médicos (SIDM) Read more 20-10-2020
Nitrosamine impurities Read more 19-10-2020
EMA starts second rolling review of a COVID-19 vaccine EMA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on a vaccine for COVID-19 known as BNT162b2, which is being developed by BioNTech in collaboration with Pfizer. Read more 07-10-2020
EU regulators fully uphold transparency and independence standards for COVID-19 treatments and vaccines The European Medicines Agency (EMA) has re-affirmed today that it will uphold its long-standing commitment to independence and transparency in its evaluation of COVID-19 treatments and vaccines. Read more 06-10-2020
EMA starts first rolling review of a COVID-19 vaccine in the EU EMA’s human medicines committee (CHMP) has started the first ‘rolling review’ of a COVID-19 vaccine, which is being developed by the company AstraZeneca in collaboration with the University of Oxford. Read more 02-10-2020
Nota Informativa para profissionais de saúde e doentes - Novo tratamento para a COVID-19: EMA recomenda a utilização de dexametasona nos doentes com COVID-19 que requerem terapia com oxigénio O INFARMED, I.P. informa que o Comité de Medicamentos para Uso Humano (CHMP) da Agência Europeia de Medicamentos (EMA na sigla em inglês) concluiu recentemente a revisão dos resultados do estudo RECOVERY, que envolveu especificamente o uso do medicamento dexametasona, no tratamento de doentes com COVID-19 internados e no hospital, e emitiu um parecer favorável a 18/09/2020 em que considera a dexametasona uma opção de tratamento para os doentes que necessitam de suporte ventilatório (desde a administração suplementar de oxigénio até à ventilação mecânica). Read more 01-10-2020
Drug Shortages: a European Solution at Last? The European Parliament's Committee on the Environment, Public Health and Food Safety had prepared a "Report on the Shortage of Medicines - how to address an emerging Problem", which has now been adopted by the European Parliament. The aim is to make the European Union regain its independence with regard to healthcare. Read more 30-09-2020
PRAC recommendations on safety signals Each month, the European Medicines Agency publishes an overview listing all safety signals discussed during the latest Pharmacovigilance Risk Assessment Committee (PRAC) meeting and the recommendations given for each of them. The overview includes PRAC recommendations for centrally and nationally authorised medicines. Read more 29-09-2020
EFPIA statement on the European Regulatory Network Strategy to 2025 EFPIA welcomes the European medicines regulatory agencies network (EMRN) draft strategy to 2025 (EUNS 2025) and fully supports the establishment of an overarching strategic plan. EFPIA views the EUNS 2025 and the related EMA’s Regulatory Science Strategy to 2025 (RSS 2025) as essential to bringing the promising next wave of innovation to patients who live with the burden of unmet medical need. Read more 15-09-2020
AstraZeneca Resumes Phase 3 COVID-19 Vaccine Trial in UK AstraZeneca announced on Saturday that it has resumed its phase 3 COVID-19 vaccine trial in the UK after pausing it last Tuesday due to a single “unexplained illness.” Read more 14-09-2020
Comunicado de Imprensa - Suspensão momentânea de vacina para COVID-19 De acordo com a informação pública, o laboratório farmacêutico AstraZeneca suspendeu momentaneamente os ensaios clínicos que decorrem a nível mundial para avaliar a segurança e a eficácia da sua vacina para a COVID-19. Read more 10-09-2020
Brexit: How to import Medicines into UK The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has just published a Guidance for Wholesaling and Importing Activities after the end of the Transition Period. Read more 09-09-2020
Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) from 1 January 2021 Pharmacovigilance system requirements from 1 January 2021 Read more 07-09-2020
COVID-19: What's new Read more 03-09-2020
EU: Checklist for Brexit Preparation The European Commission has published a 'Brexit Readiness Checklist' for companies doing business with the UK. Read more 02-09-2020
PIC/S publishes Q&A document on Health Based Exposure Limits and Cross-Contamination In the last newsletter you could already read about a new Aide-Memoire of the PIC/S for the inspection of health-based exposure limits (HBEL). At the same time, the PIC/S has published a Q&A document on HBEL and cross-contamination. What is behind this Q&A paper? Read more 26-08-2020
GDP Monograph for Active Substances: Interactive PDF now available In June 2020, the "Good Distribution Practice for Active Substances Guidance on interpretation and implementation" has been published as a joint publication of the ECA Foundation's GDP Association and the Pharmaceutical Quality Group of the Chartered Quality Institute. The monograph is based on the text of the European Commission "Guidelines of 19 March 2015 on principles of Good Distribution Practice of active substances for medicinal products for human use (2015/C 95/01)", but is applicable to all sectors of the distribution network worldwide. It will be of benefit to all involved in active substance distribution activities for initial training, continuing professional development and as a reference source or audit tool. Read more 25-08-2020
COVID-19: What's new Read more 21-08-2020
Coronavirus: Commission approves funding for training of healthcare professionals in intensive care skills Read more 20-08-2020
Can the Application of Safety Features be outsourced? The European Commission has published a new version of the "Questions & Answers regarding the implementation of the rule on safety features for medicinal products for human use" - now the 18th version. Read more 19-08-2020
Nitrosamines risk assessment: update for CEP holders In October 2019, the EDQM requested companies holding CEPs to perform a risk assessment of their chemically synthesised APIs with regards a potential nitrosamines formation, using quality risk management principles. It was highlighted that the factors to be taken into account were outlined in the dedicated Questions and Answers documents available on the EMA and CMDh websites. Read more 17-08-2020
Estratégia da Rede de Agências Europeias de Medicamentos em consulta pública A Agência Europeia do Medicamento (EMA) e os chefes das agências nacionais de medicamentos nos países europeus desenvolveram uma estratégia conjunta para os próximos cinco anos, que se encontra disponível para consulta pública até 4 de setembro. Read more 14-08-2020
Evaluation of the medicines for rare diseases and children legislation On 11 August 2020, the European Commission published its evaluation (main document – part 1, annexes: part 2, part 3, part 4, part 5, part 6) on the legislation for medicines for rare diseases and for children. An executive summarySearch for available translations of the preceding link••• in English, French and German is also available. Read more 12-08-2020
INFORMATION ON NITROSAMINES FOR MARKETING AUTHORISATION HOLDERS CMDh practical guidance for Marketing Authorisation Holders of nationally authorised products (incl. MRP/DCP) in relation to the Art. 5(3) Referral on Nitrosamines Read more 11-08-2020
The E2B(R3) User Guide v1.1 Available Now on the ICH Website The v1.1. of the User Guide of EDQM terminologies for Dose Forms and Routes of Administration for Individual Case Safety Reports in E2B(R3) message (i.e. E2B(R3) User Guide v1.1) reached Step 4 of the ICH process in July 2020. Read more 10-08-2020
FIP atualiza relatório sobre vacinação nas farmácias A Federação Internacional Farmacêutica (FIP) publicou um novo relatório sobre o impacto e contributo dos farmacêuticos para a cobertura vacinal, com o título “An overview of pharmacy’s impact on immunisation coverage: a global survey". Read more 07-08-2020
Brexit: Sponsors Need to Establish an EU-QP Since 1 February 2020, the UK has withdrawn from the EU. The transition period ends on 31 December 2020. Since no extension was requested as of July 1 2020, there is no possibility for further extension beyond that date. Read more 06-08-2020
The ICH S11 introductory training presentation available now on the ICH website The ICH S11 Guideline on Nonclinical Safety Testing in Support of Development of Paediatric Pharmaceuticals reached Step 4 of the ICH Process in April 2020. Read more 04-08-2020
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UK Group Receives CE Mark for COVID-19 Rapid Antibody Test UK diagnostics company Abingdon Health has received a CE Mark for a COVID-19 antibody test that delivers results in 20 minutes. Read more 31-07-2020
Guidance for medicine developers and companies on COVID-19 The European Medicines Agency (EMA) is providing guidance for medicine developers and pharmaceutical companies to help speed up medicine and vaccine development and approval for COVID-19, and on how they should address the regulatory challenges arising from the COVID-19 pandemic. Read more 28-07-2020
EMA starts review of dexamethasone for treating adults with COVID-19 requiring respiratory support EMA is reviewing results from the RECOVERY study arm that involved the use of dexamethasone in the treatment of patients with COVID-19 admitted to hospital. This part of the study looked into the effects of adding dexamethasone to usual care in adults receiving invasive ventilation, those given oxygen (e.g. through a mask) or those receiving no oxygen. Invasive ventilation involves use of a machine to push air through a tube inserted into the patient’s airway. Read more 27-07-2020
CHMP's Assessment Report on Nitrosamines published On 9 July 2020, the final report on nitrosamine contamination was published on the EMA website. This final statement of the CHMP entitled "Assessment report - Nitrosamine impurities in human medicinal products" EMA/369136/2020 represents the end of the procedure under Article 5(3) of Regulation 726/2004, which started on 10 September 2019. The 90-page document contains the current state of science and knowledge regarding nitrosamine impurities in human medicinal products and provides recommendations for manufacturers of medicinal products based on chemically defined APIs and biological medicinal products. Read more 23-07-2020
Pharmacovigilance Audits and Inspections during COVID-19 The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) released a Q&A document on adaptations to the regulatory framework to address challenges arising from the COVID-19 pandemic. The document is updated continuously and includes Q&As relating to pharmacovigilance. Read more 21-07-2020
Covid-19: Handling of Marketing Authorisations The processes and procedures relating to marketing authorisations are still strongly influenced by the corona pandemic. On the website of the HMA (Heads of Medicines Agencies) this has been reiterated and the available templates and information to facilitate and manage marketing authorisations and registration procedures have been consolidated and listed. Read more 16-07-2020
Regulatory Authorities worldwide work more closely together because of COVID-19 The Swiss authority Swissmedic announced on its website that regulatory authorities around the world will work more closely together due to Covid-19. Three areas have been identified for this: research during pregnancy, medicinal products from clinical trials and monitoring of vaccines in terms of safety and efficacy. Read more 15-07-2020
Infarmed e restantes agências de medicamentos europeias juntas no combate à COVID-19 Os Chefes das Agências do Medicamento Europeias (Heads of Medicines Agencies) estão a promover uma iniciativa de comunicação, a nível da União Europeia, para melhor dar a conhecer aos cidadãos europeus o trabalho conjunto das várias agências de medicamentos europeias no combate à COVID-19. Read more 13-07-2020
EMA finalises opinion on presence of nitrosamines in medicines EMA’s human medicines committee (CHMP) has issued an opinion requiring companies to take measures to limit the presence of nitrosamines in human medicines as far as possible and to ensure levels of these impurities do not exceed set limits. Read more 10-07-2020
Procedural guidance during COVID-19 pandemic Read more 09-07-2020
Distant Assessment leads to GMP Non-Compliance Report Many GMP inspectorates have started performing remote inspections for selected sites for the duration of the outbreak of Covid-19. In the EU for example, the European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have agreed a series of measures to mitigate the impact of disruptions caused by COVID-19 on the conduct of inspections of manufacturing facilities or other sites relevant for medicinal products in the EU. In an Q&A document, it is stated that for new sites/facilities, a "distant assessment" conducted by an EU/EEA competent authority may be an option. A GMP certificate may be then "granted depending on the outcome of the assessment". Read more 08-07-2020
PRAC recommendations on signals adopted at the 8-11 June 2020 PRAC meeting Read more 07-07-2020
Is an Update of the QPPV´s Contact Details a Variation? The Co-ordination Groups for Mutual Recognition and Decentralized Procedures (CMDh and CMDv) recently published a revised version of the Q&A paper regarding variations. Read more 03-07-2020
Impact of COVID-19 on EudraVigilance Reporting and Labeling The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) released a Q&A document on adaptations to the regulatory framework to address challenges arising from the COVID-19 pandemic. The document includes flexible approaches for adverse reactions reporting and labeling. Read more 02-07-2020
New GDP Monograph for Active Substances published The Good Distribution Practice for Active Substances Guidance on interpretation and implementation has been published as a joint publication of the ECA Foundation's GDP Association and the Pharmaceutical Quality Group of the Chartered Quality Institute. The monograph is based on the text of the European Commission "Guidelines of 19 March 2015 on principles of Good Distribution Practice of active substances for medicinal products for human use (2015/C 95/01)", but is applicable to all sectors of the distribution network worldwide. Read more 01-07-2020
First COVID-19 treatment recommended for EU authorisation EMA’s human medicines committee (CHMP) has recommended granting a conditional marketing authorisation to Veklury (remdesivir) for the treatment of COVID-19 in adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen. Read more 26-06-2020
Recommendations on medication errors In the European Union (EU), national competent authorities and the European Medicines Agency (EMA) play a key role in identifying and reducing the risk of medication errors before and after the authorisation of a medicine. EMA applies a consistent approach to communicating to patients and healthcare professionals on any additional measures recommended by the Agency to reduce the risk of medication errors with a specific medicine. Read more 25-06-2020
Nitrosamine impurities In 2018, nitrosamine impurities, including N-nitrosodimethylamine (NDMA), were found in a number of blood pressure medicines known as 'sartans'. This led to some product recalls and to a regulatory review, which set strict new manufacturing requirements for these medicines. Subsequently, a nitrosamine impurity has been detected in batches of ranitidine, a medicine used to treat heartburn and stomach ulcers, and the Agency's Committee for Medicinal Products for Human Use (CHMP) has started a review. Read more 24-06-2020
European Commission, EMA and FDA agree new priorities to strengthen their collaboration on medicines Senior officials from the European Commission (EC - DG SANTE), EMA and the United States Food and Drug Administration (FDA) held their 2020 bilateral regulatory dialogue meeting on 18 and 19 June. During this virtual two-day meeting, the authorities reviewed their ongoing joint initiatives, discussed strategic priorities for the coming years and identified areas where their already close collaboration can be further strengthened. Read more 23-06-2020
CEPs: What Applicants and Authorisation Holders should know! Due to the current situation in Europe, many applicants and marketing authorisation holders (MAHs) are increasingly asking how and to what extent "CEPs" (Certificate of Suitability of Monographs of the European Pharmacopoeia) are currently being processed and issued. Read more 19-06-2020
International regulators stress value of safe and effective vaccines EMA has endorsed two statements about the importance, safety and effectiveness of vaccines published today by the International Coalition of Medicines Regulatory Authorities (ICMRA). International regulators from around the world have come together and jointly developed these statements for healthcare professionals and the general public to give assurance that the regulatory processes for the authorisation and safety monitoring of vaccines are robust, independent and focus firmly on public health. Read more 18-06-2020
Remote GCP Inspections The European Medicines Agency (EMA) released a new guidance explaining how remote Good Clinical Practice (GCP) inspections should be conducted during the COVID-19 pandemic. Read more 17-06-2020
Follow-up activities after Pharmacovigilance Inspections EMA´s Pharmacovigilance Inspectors Working Group adopted a new guideline on the follow-up activities of pharmacovigilance inspections (effective since May 1, 2020). It applies to the follow-up of pharmacovigilance inspections of Marketing Authorization Holders (MAHs) with centrally authorized products (CAPs), nationally authorized products (NAPs), products authorized via the mutual recognition or decentralized procedure (MRP, DCP). The new guideline replaces the EMA document “Union procedure on the management of pharmacovigilance inspection findings which may impact the robustness of the benefit-risk profile of the concerned medicinal products”. Read more 16-06-2020
EDQM provides COVID-19 vaccine developers with free access to quality standards applicable in Europe The EDQM is committed to supporting vaccine developers during the coronavirus disease (COVID-19) pandemic – as well as contributing to the wider global effort to combat the virus – by openly sharing knowledge and offering temporary free access to relevant guidance and standards. Read more 08-06-2020
EU Member States report illegal and ineffective disinfectants Several EU countries have signalled to ECHA and the European Commission that the COVID-19 pandemic has led to an increased number of non-compliant (hand) disinfectants on the market. National enforcement authorities are taking action to protect citizens from the risks of illicit and ineffective products. Read more 05-06-2020
Practical guidance of the CMDh for facilitating the handling of processes during the COVID-19 crisis Read more 04-06-2020
Derogation for Process Validation due to Covid-19 Europe is taking exceptional steps to ensure that the population continues to receive high quality, effective and safe medicinal products during the Covid-19 pandemic. A Questions & Answers document has been prepared in cooperation between the European Commission, the Coordination Group for Mutual Recognition and Decentralised Procedures (CMDh), the "Inspectors Working Group" and the European Medicines Agency (EMA) - please also see "COVID-19: Update of the Q&A document - Validity of GDP Certificates and Wholesale Authorisations". At the end of May, special features for process validation (question 6.2) were added under the heading "GMP Flexibilites". Read more 03-06-2020
COVID-19: reminder of the risks of chloroquine and hydroxychloroquine EMA is reminding healthcare professionals to closely monitor patients with COVID-19 who are receiving chloroquine or hydroxychloroquine, given the serious side effects that can result from treatment with these medicines. Read more 01-06-2020
European medicines regulatory network fully mobilised in fight against COVID-19 The development and availability of medicines and vaccines for all patients in the European Union, including those with COVID-19, is the number one priority for the European medicines regulatory network. EMA, together with EU Member States and the European Commission, has published a PDF iconplan outlining principles for how the network will ensure that core public and animal health regulatory activities, such as the authorisation, maintenance and supervision of human and veterinary medicines will continue to be carried out during the ongoing COVID-19 pandemic. Read more 29-05-2020
Prospective dialogue between developers and regulators makes for better evidence generation EMA, in collaboration with other parties, has recently published two scientific articles outlining the importance of early interactions as an opportunity to improve the generation of evidence required for bringing innovation to patients. Read more 28-05-2020
EMA commissions independent research to prepare for real-world monitoring of COVID-19 vaccines EMA is engaging early with researchers to ensure that a European infrastructure will be in place to effectively monitor COVID-19 vaccines in the real world, once these are authorised in the European Union. The Agency has signed a contract with Utrecht University as coordinator of the EU Pharmacoepidemiology and Pharmacovigilance Research Network, a public-academic partnership of 22 European research centres, to conduct preparatory research into data sources and methods that can be used to monitor the safety, effectiveness and coverage of COVID-19 vaccines in clinical practice. The ACCESS (vACcine Covid-19 monitoring readinESS) project will be led by the University Medical Center Utrecht (UMCU) and Utrecht University. Read more 27-05-2020
Resposta à COVID-19 aprovada em Assembleia Mundial da Saúde A 73.ª Assembleia Mundial da Saúde, da Organização Mundial da Saúde (OMS), reunida por teleconferência, aprovou por consenso, no passado dia 19 de maio, uma resolução, promovida pela União Europeia, intitulada “Resposta à COVID-19”. Read more 25-05-2020
Global regulators commit to cooperate on observational research in the context of COVID-19 Regulators from around the world have agreed three priority areas for cooperation on observational research during COVID-19. They will collaborate on pregnancy research, on medicines used in clinical practice and on vaccine safety and effectiveness monitoring. Read more 21-05-2020
What Marketing Authorisation Holders need to know now about their Registrations On 10 April 2020, the European Medicines Agency (EMA) together with the Heads of Medicines Agencies (HMA) and the European Commission (EC) published a first version of the document "QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC", which is continuously updated and adapted. Read more 20-05-2020
Update of EU recommendations for 2020/2021 seasonal flu vaccine composition EMA has issued an update of the EU recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from autumn 2020. Read more 18-05-2020
Máscaras: normas aplicáveis e tipologia Com o início da fase de desconfinamento, o INFARMED, I.P. tem vindo a ser questionado sobre a tipologia de máscaras e a sua utilização. Read more 15-05-2020
USP´s Quality Considerations for Medical Cannabis Authors from the USP Cannabis Expert Panel recently published an article entitled "Cannabis Inflorescence for Medical Purposes: USP Considerations for Quality Attributes". The paper was published on April 13, 2020 in the Journal of Natural Products (J. Nat. Prod. 2020, 83, 1334-1351). So far neither a USP Monograph on Cannabis nor a Ph. Eur. Monograph is available. However, there are some national Monographs for Cannabis Flower and Cannabis Extract, for example in the German Pharmacopoeia (Deutsches Arzneibuch, DAB). Read more 13-05-2020
EMA recommends expanding remdesivir compassionate use to patients not on mechanical ventilation EMA’s human medicines committee (CHMP) has recommended expanding the compassionate use of the investigational medicine remdesivir so that more patients with severe COVID 19 can be treated. Read more 12-05-2020
Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 In a high-level meeting on COVID-19 policies, organised by EMA under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA), international regulators from around the world discussed strategic issues and regulatory approaches to ensure a coordinated response to the pandemic. They stressed the need for alignment on pre- and post-authorisation regulatory requirements to facilitate the rapid development, evaluation and availability of medicines for the treatment and prevention of coronavirus disease. Read more 06-05-2020
Infarmed lança infografias alertando para a importância da notificação de reações adversas em doentes com COVID-19 O Infarmed, no seguimento de uma ação de informação promovida pela Agência Europeia do Medicamento (EMA na sigla inglesa) à qual se associa, produziu duas infografias – uma dirigida aos cidadãos e outra aos profissionais de saúde – com o objetivo de alertar os doentes com doença COVID-19 (confirmada ou suspeita) e os profissionais que os acompanham, para a importância de notificar qualquer suspeita de reação adversa a medicamentos (RAM), estejam eles a ser ministrados no âmbito da COVID-19 ou sejam de toma habitual. Read more 05-05-2020
EMA starts rolling review of remdesivir for COVID-19 EMA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on the use of the investigational antiviral medicine remdesivir for the treatment of coronavirus disease (COVID-19). Read more 04-05-2020
New EU/EMA planned Actions in the Context of the COVID-19 Pandemic The European Medicines Agency EMA has published three press releases on current EU/EMA activities in the context of the COVID-19 pandemic. Read more 29-04-2020
Guidance for medicine developers and companies on COVID-19 The European Medicines Agency (EMA) is providing guidance for medicine developers and pharmaceutical companies to help speed up medicine and vaccine development and approval for COVID-19, and on how they should address the regulatory challenges arising from the COVID-19 pandemic. Read more 20-04-2020
Avaliação da presença de nitrosaminas - Adiamento do prazo para submissão e perguntas frequentes Conforme divulgado nas páginas eletrónicas da Agência Europeia do Medicamento (EMA na sigla inglesa) e do Grupo de Coordenação CMDh (Coordination group for Mutual Recognition and Decentralised procedure, human), o prazo para a submissão do risco da presença de nitrosaminas (etapa 1) foi prolongado até ao dia 1 de outubro 2020. Read more 15-04-2020
EMA establishes task force to take quick and coordinated regulatory action related to COVID-19 medicines As part of its health threat plan activated to fight COVID-19, the Agency has finalised and published the PDF iconcomposition and objectives of its COVID-19 EMA pandemic Task Force (COVID-ETF), which assists Member States and the European Commission in dealing with development, authorisation and safety monitoring of therapeutics and vaccines intended for treatment or prevention of COVID-19. Read more 13-04-2020
Nova edição da newsletter com resumo da informação da área COVID-19 Está disponível nova edição da newsletter com o resumo da informação mais recentemente publicada na área COVID-19. Read more 09-04-2020
Ph. Eur. launches a public consultation on a new general chapter for the analysis of N-Nitrosamines The European Pharmacopoeia (Ph. Eur.) seeks feedback on its new general chapter on the analysis of N-nitrosamine impurities in active substances (2.4.36). Read more 08-04-2020
EU authorities agree new measures to support availability of medicines used in the COVID-19 pandemic The continued availability of medicines, in particular those used for patients with COVID-19, is of critical concern for EMA and its partners in the European medicines regulatory network in light of the medical emergency presented by the pandemic. Read more 07-04-2020
Commission postpones application of the Medical Devices Regulation to prioritise the fight against coronavirus Read more 06-04-2020
Informação às entidades fabricantes e de distribuição de medicamentos gases medicinais e de dispositivos médicos (COVID-19) A Agência Europeia do Medicamento (EMA na sigla inglesa) e demais parceiros na rede europeia de regulação de medicamentos, incluindo o INFARMED, I.P., encontram-se a monitorizar detalhadamente o potencial impacto da pandemia da doença causada pelo coronavírus (COVID-19) no fornecimento de medicamentos gases medicinais e de dispositivos médicos. Read more 02-04-2020
Regulatory guidance for medical devices Check the legal requirements you need to meet before you can place a medical device on the market and see how MHRA monitors compliance. Read more 01-04-2020
Information package for certificates of medicinal products issued by the European Medicines Agency Read more 31-03-2020
European Commission Calls for One Year Delay of Medical Device Regulation Read more 30-03-2020
Deadline extension to all CEP holders to complete step 1 Risk Assessments regarding presence of nitrosamines (now 31st July 2020) The EDQM recognises that due to the impact of the global outbreak of COVID-19, many CEP holders are encountering significant challenges in completing the work within the timelines previously announced in the EDQM request to CEP holders to perform a risk evaluation of their chemically synthesised APIs with regards nitrosamine formation, published on the EDQM Website (EDQM request October 2019). Read more 27-03-2020
Information on nitrosamines for marketing authorisation holders Read more 26-03-2020
EU GMP Annex 21 finally published On 20 March, after some delays, the new Annex 21 to the EU-GMP Guidelines was published as a draft. The document is entitled "Importation of medicinal Products". The "Concept Paper" was already published on 13 May 2015 (EMA/238299/2015) and the consultation phase ended in August 2015. The first draft for regulatory consultation was published in November 2016. Since then, no further activities or versions have been issued. Read more 25-03-2020
Código de Conduta nos circuitos de distribuição e venda de produtos fitofarmacêuticos A DGAV republica o Código de conduta nos circuitos de distribuição e venda de produtos fitofarmacêuticos na sua edição de 2019, revista e actualizada face à Lei n.º 26/2013 de 11 de abril. Esta reedição contou com a colaboração e revisão crítica de diferentes entidades públicas e privadas de áreas de competência relevantes para os conteúdos do Código e visa o apoio de todos aqueles que, na sua actividade profissional, manuseiam, distribuem e comercializam produtos fitofarmacêuticos de utilização profissional. Read more 24-03-2020
Guidance to sponsors on how to manage clinical trials during the COVID-19 pandemic The European Commission, the European Medicines Agency (EMA) and national Head of Medicines Agencies (HMA) have published new recommendations for sponsors on how to manage the conduct of clinical trials in the context of the coronavirus disease (COVID-19) pandemic. The impact of the pandemic on European health systems and more broadly on society, will make it necessary for sponsors to adjust how they manage clinical trials and the people who participate in these trials. Read more 23-03-2020
Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure Read more 20-03-2020
Notice to stakeholders ´Withdrawal of the United Kingdom and EU rules for medicinal products for human and veterinary use" Read more 19-03-2020
CMDh Guidance Document on the Numbering System for the Procedures for Mutual Recognition and Decentralised Read more 17-03-2020
Rastreabilidade de stocks de medicamentos para COVID-19 - formato de reporte Na sequência da circular informativa n.º 062/CD/100.20.200 de 05/03/2020, o INFARMED, I.P. divulga por meio desta circular o formato de reporte da informação a disponibilizar relativamente ao stock disponível nas suas instalações dos medicamentos constantes da referida circular, as aquisições e vendas semanais e identificando as entidades destinatárias dos mesmos. Read more 16-03-2020
Clinical pharmacology and pharmacokinetics: questions and answers Read more 13-03-2020
Corrigendum to Commission Regulation (EU) 2019/1966 of 27 November 2019 amending and correcting Annexes II, III and V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products ( OJ L 307, 28.11.2019 ) Read more 12-03-2020
National recommendations for requests to act as RMS in DCPs Read more 11-03-2020
Questions and answers (version 17) - Safety features for medicinal products for human use Read more 10-03-2020
CMDh practical guidance for Marketing Authorisation Holders of nationally authorised products (incl. MRP/DCP) in relation to the Art. 5(3) Referral on Nitrosamines Read more 09-03-2020
EMA EudraVigilance Registration Manual Read more 05-03-2020
Update on nitrosamines in EU medicines EU and national authorities are continuing their work to prevent and manage the presence of nitrosamine impurities in EU medicines. Read more 04-03-2020
Standard operating procedure for management of periodic safety update reports (PSURs) for centrally authorised veterinary medicinal products: Annex I – contact details of national competent authorities (NCAs) for PSUR submission Read more 03-03-2020
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 02-03-2020
CMDh Best Practice Guide on Multilingual Packaging Read more 28-02-2020
QbD for TDS: FDA´s new draft guidance The FDA published a draft guideline "Transdermal and Topical Delivery Systems - Product Development and Quality Considerations". Read more 27-02-2020
Draft Annex 1: New Requirements for Lyophilization? Will the revised Annex 1 introduce new GMP requirements for lyophilized products? Read more 26-02-2020
FDA Revises Guidance on Electronic Drug Submissions The FDA issued a final guidance on online submissions for certain drug product applications, clarifying that some submission types are exempt or may qualify for a waiver. Read more 24-02-2020
Second joint targeted stakeholders' consultation on the revision of Annex 1, on manufacturing of sterile medicinal products, of the PIC/S – EU GMP Guide Read more 21-02-2020
ICH S5(R3) reaches Step 4 of the ICH Process The ICH S5(R3) Guideline on Detection of Toxicity to Reproductions for Human Pharmaceuticals reached Step 4 of the ICH Process in February 2020. Read more 19-02-2020
Implementation of risk assessment requirements to control elemental impurities in veterinary medicinal products Read more 18-02-2020
Post-Brexit UK to Overhaul Medical Device Authority The new legislation would empower the health department to impose monetary penalties as an alternative to criminal prosecution. Read more 17-02-2020
FDA Guidance Seeks to Speed Reviews of Biosimilars for Fewer Conditions of Use As part of its ongoing efforts to encourage biosimilars, the FDA issued draft guidance on the agency’s abbreviated review pathway for sponsors of biosimilars with more limited conditions of use than the reference product. Read more 14-02-2020
Formulário eletrónico para avaliação da presença de nitrosamina em medicamento Conforme descrito na Circular Informativa n.º 145/CD/100.20.200 de 27/09/2019, os titulares de Autorização de Introdução no Mercado (TAIM), como medida de precaução, têm de efetuar a revisão dos medicamentos que contêm substâncias ativas sintetizadas quimicamente para verificar a presença de nitrosaminas e testar todos os medicamentos com potencial risco, reportando, em ambos os casos, os resultados às autoridades nacionais competentes. Read more 12-02-2020
New GMP Guidance for Marketing Authorisation Holders After long discussions, the European Medicines Agency EMA has published a Reflection Paper on Good Manufacturing Practice and Marketing Authorisation Holders (EMA/457570/2019). Read more 11-02-2020
UK Offers Grace Period for Sudden Notified Body Withdrawals Some devicemakers will be allowed to continue placing their products on the EU market while they deal with the unexpected withdrawal of a notified body, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said. Read more 10-02-2020
UK Waves Goodbye to EU as Transition Period Begins The UK finally departed from the European Union on January 31, beginning a transition period in which EU drug regulations will still apply in the UK. Read more 07-02-2020
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 06-02-2020
EMA to support development of vaccines and treatments for novel coronavirus To contribute to the global response to the outbreak of the novel coronavirus (2019-nCoV) infections, EMA is taking concrete actions to accelerate the development and availability of medicinal products for the treatment and prevention of the new coronavirus. Read more 05-02-2020
La AEMPS publica una guía para el envío de información sobre nitrosaminas por parte de los Titulares de Autorizaciones de Comercialización (TAC) La guía tiene como objetivo potenciar la evaluación, por parte de los TAC, del riesgo de la presencia de nitrosaminas en todos los medicamentos de uso humano de síntesis química. Read more 04-02-2020
UK withdrawal from the EU on 31 January 2020 The United Kingdom will formally leave the European Union on 31 January 2020 and will become a third country to the EU. On 1 February 2020 a transition period will start which is due to end on 31 December 2020. Read more 03-02-2020
Falta de medicamentos agrava-se na Europa O Grupo Farmacêutico da União Europeia (PGEU) está a acompanhar o fenómeno de escassez de medicamentos em vários países europeus. Read more 31-01-2020
Report on public consultation on the 'Electronic product information for human medicines in the European Union - draft key principles' Read more 30-01-2020
SCCS - Read the new factsheet: "The SCCS Guidance on the safety assessment of nanomaterials in cosmetics" Read more 29-01-2020
FDA Announces Plan for Electronic Orphan Drug Designation Submissions The FDA plans to allow sponsors to submit orphan drug designation requests electronically later this year. Read more 28-01-2020
Produtos fitofarmacêuticos - Classificação harmonizada de substâncias ativas A DGAV informa que foi publicado o Regulamento de execução (UE) 2020/103 da Comissão de 17 de janeiro de 2020 que altera o Regulamento de Execução (UE) n.º 844/2012 no que diz respeito à classificação harmonizada de substâncias ativas. Este diploma visa o alinhamento do processo de submissão e avaliação da proposta de classificação harmonizada da substância ativa à Agência Europeia dos Produtos Químicos com o processo de avaliação para efeitos de decisão relativa à renovação da aprovação das substâncias ativas, em conformidade com o que se encontra previsto no artigo 36.º, n.º 2, do Regulamento (CE) n.º 1272/2008 do Parlamento Europeu e do Conselho. Read more 27-01-2020
European Medicines Agency’s privacy statement for the EMA Account Management system Read more 24-01-2020
Choice of timetable for type II variations and worksharing applications Read more 23-01-2020
Procedural advice for orphan medicinal product designation: Guidance for sponsors Read more 22-01-2020
Detailed guide regarding the EudraVigilance data management activities by the European Medicines Agency Read more 21-01-2020
MedTech Europe Renews Alarm Over MDR Transition Time is running out for devicemakers to meet the May 26 deadline to renew or extend their device certificates under the new EU Medical Devices Regulation, MedTech Europe stressed in its latest status report. Read more 20-01-2020
EMA/CHMP publishes new Q&A Document on Comparability Considerations for ATMPs The EMA/CHMP offers assistance and support in the form of the Scientific Advice to the developing or approving company or institution for the development and approval of drugs. Read more 17-01-2020
Announcement of the EMA Management Board - Confirmation of the mandatory use of the ISO Individual Case Report standard based on ICH E2B(R3) modalities and related ISO standard terminology Read more 16-01-2020
Disponível webservice para notificação de faltas de medicamentos Conforme previsto no Regulamento de Gestão da Disponibilidade do Medicamento, o webservice para comunicação automática das faltas de medicamentos está disponível. Read more 15-01-2020
Ranitidine Can Generate NDMA Under Storage Conditions, Lab Says Ranitidine can generate N-nitrosodimethylamine (NDMA) when stored at higher temperatures, a research laboratory has found, raising new safety concerns. Read more 14-01-2020
IRIS guide for Parallel Distribution applicants Read more 13-01-2020
Orientações europeias dirigidas a fabricantes de dispositivos médicos da classe I No passado dia 18 de dezembro de 2019 foi publicado, pela Comissão Europeia, o documento "MDCG 2019-15 Guidance notes for manufacturers of Class I medical device" relativo às orientações dirigidas a fabricantes para a colocação no mercado de dispositivos médicos de classe I. Read more 10-01-2020
Pharmeuropa 32.1 just released All new texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 32.1 is 31 March 2020. Read more 08-01-2020
Ranitidine Can Generate NDMA Under Storage Conditions, Lab Says Ranitidine can generate N-nitrosodimethylamine (NDMA) when stored at higher temperatures, a research laboratory has found, raising new safety concerns. Read more 06-01-2020
Canada Releases Final Guidance on Software as a Medical Device Health Canada has finalized guidance on software as a medical device (SaMD) that clarifies how it fits into the agency’s regulatory framework and how devicemakers can comply. Read more 03-01-2020
New symbols for medical device label now available on the ISO website In May this year, MedTech Europe published a guidance on symbols recommended to be used on medical device labels for MDR compliance before the revision of ISO standard 15223-1 is completed. Read more 02-01-2020
ISO Issues Risk Management Standard for Devices The International Organization for Standardization (ISO) has released a standard for device manufacturers for assessing and controlling potential medical device hazards. Read more 27-12-2019
Revisão Anual de Preços - 2020 Revisão Anual de Preços de Medicamentos Genéricos e Não Genéricos_2020 Read more 23-12-2019
Trump Administration takes historic steps to lower U.S. prescription drug prices President Trump, along with the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration, issued a notice of proposed rulemaking (NPRM) that, if finalized, would allow for the importation of certain prescription drugs from Canada. In addition, the Administration is announcing the availability of a new draft guidance for industry that describes procedures drug manufacturers can follow to facilitate importation of prescription drugs, including biological products, that are FDA-approved, manufactured abroad, authorized for sale in any foreign country, and originally intended for sale in that foreign country. Read more 19-12-2019
4-year overview of pharmacovigilance activities in the EU shows robust and effective medicines safety system A report on the activities ensuring the safety of medicines carried out by EMA and the national competent authorities of the European Union (EU) Member States, Norway and Iceland from 2015 to 2018 shows that the EU pharmacovigilance system is strong and adaptable and has had a positive impact on public health. Read more 18-12-2019
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure Read more 17-12-2019
Apply for a licence to market a medicine in the UK How to license a medicine for sale in the UK and Europe, including applications through national, centralised and decentralised procedures. Read more 16-12-2019
VICH GL58 stability testing of new veterinary drug substances and medicinal products in climatic zones III and IV - First version Read more 13-12-2019
Outcome of the 165th European Pharmacopoeia Commission During its 165th session, held in Strasbourg on 26 and 27 November 2019, the European Pharmacopoeia (Ph. Eur.) Commission (re)appointed more than 850 experts to its current 21 groups of experts and 39 active working parties for a new term running from November 2019 to November 2022. Read more 12-12-2019
Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with chapter P.III on pharmacovigilance for the use of medicines by pregnant and breastfeeding women Read more 11-12-2019
EMA update on metformin diabetes medicines EMA is aware that trace amounts of an impurity, N-nitrosodimethylamine (NDMA), have been found in a small number of metformin diabetes medicines outside the EU. Read more 09-12-2019
Statement from Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, on impurities found in diabetes drugs outside the U.S. The U.S. Food and Drug Administration has been investigating the presence of genotoxic impurities, called nitrosamines, in some types of drugs. Over the past year and a half, several drug products including angiotensin II receptor blockers (ARBs) and ranitidine, commonly known as Zantac, have been found to contain small amounts of nitrosamines such as N-Nitrosodimethylamine (NDMA). During this time, there has been an ongoing investigation into the presence of nitrosamines in other drug products. This effort is focused on ensuring the drugs used by Americans continue to meet strict quality standards. Read more 06-12-2019
FDA Issues Guidance on Transdermal and Topical Drug Delivery Systems The FDA outlined its current thinking on the information sponsors of transdermal and topical delivery systems (TDS) should include in their NDAs and ANDAs in draft guidance. Read more 05-12-2019
European authorities working to avoid shortages of medicines due to Brexit – Questions and answers Read more 04-12-2019
ICH Q12 adopted The International Council for Harmonization (ICH) met in Singapore from 16 – 20 November 2019. The key milestone reached was the adoption of the new ICH Q12 Guideline (Step 4 of the ICH process) on the Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. The new ICH Q12 Guideline including two Annexes is complementary to ICH Quality Guidelines Q8 to Q11. According to ICH, it aims to "promote innovation and continual improvement in the pharmaceutical sector, and strengthen quality assurance and reliable supply of product, including proactive planning of global supply chain adjustments". Read more 03-12-2019
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 Novemver 2019 At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities, which cover all aspects of the risk management of the use of medicines: assessment of safety signals, risk management plans, periodic safety update reports and post-authorisation safety studies. Read more 02-12-2019
Questions and answers on “Information on nitrosamines for marketing authorisation holders” Read more 29-11-2019
La AEMPS establece un plazo de adecuación del etiquetado y las instrucciones de uso de Productos Sanitarios como consecuencia de los cambios realizados por un posible brexit A principios de abril, la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) informó, a través de la nota informativa PS, 8/2019, sobre las cuestiones más relevantes relativas a los productos sanitarios, en el caso de que a partir de la fecha del brexit, el Reino Unido pase a considerarse un tercer país, sin que se haya llegado a un acuerdo con la Unión Europea (UE27). Read more 28-11-2019
Final Guideline on CCP for ATMPs published In the recent past, ATMPs have increasingly moved from research and development to clinical trial phases or to the status of approved medicinal product. As a result, this product group has increasingly moved into the focus of regulatory authorities and GMP inspectors. In the near past, you could therefore read about regulatory developments on several occasions, both in the USA and in Europe, for example through the Stakeholder Consultation on the Draft Guideline GCP for ATMP. The results of the consultation are also available on the website of the European Commission. Read more 27-11-2019
Falsified Medicines: New EU Aide Memoire for GDP The European Commission has published an aide memoire for Good Distribution Practices (GDP) inspection of wholesalers’ compliance with Commission Delegated Regulation (EU) 2016/161 for safety features. The six-page document has been available online since 18 November 2019. Read more 26-11-2019
Novo portal e novo protocolo de cedência de informação A cedência da base de dados de medicamentos e dispositivos médicos e outros produtos comparticipados passará, a partir de hoje, a ser processada através do portal CITS: Cedência de Informação de Tecnologias de Saúde. Read more 25-11-2019
Information for the package leaflet regarding ethanol used as an excipient in medicinal products for human use Read more 22-11-2019
Report from the meeting held on 12-14 November 2019 Read more 21-11-2019
Nitrosamines in Elastomers? An USP Stimuli article on Elastomeric Components for Inhalation Packaging / Delivery Systems has been published in Pharmacopeial Forum, proposing to test for nitrosamines in elastomeric components used for inhalation products. Read more 20-11-2019
Commission report on the national and European Medicines Agency experience regarding the list of medicines for human use subject to additional monitoring Read more 19-11-2019
Companies need to improve communication of hazardous substances in products A Forum pilot enforcement project in 15 participating countries has found that 12 % of inspected products contain substances of very high concern (SVHCs). The majority (88 %) of suppliers of these products are failing to communicate sufficient information to their customers about SVHCs in products they supply. Read more 18-11-2019
FDA Suggests Alternative NDMA Test for Ranitidine The FDA is recommending a second low-temperature test for determining if ranitidine products contain the probable carcinogen N-nitrosodimethylamine (NDMA). Read more 15-11-2019
Revisão da lista de medicamentos abrangidos pela notificação prévia de exportação ou distribuição para outros Estados-membros Circular Informativa n.º 174/CD/100.20.200, de 11/11/2019 - Foi publicada a Deliberação n.º 095/CD/2019, de 11 de novembro, que veio atualizar a lista de medicamentos cuja exportação ou distribuição para outros Estados-membros da União Europeia carece de prévia notificação ao Infarmed. Read more 14-11-2019
FDA works on regulatory pathways for CBD products Cannabidiol (CBD) is currently marketed in a variety of product types, such as oil drops, infused pouches, capsules, syrups, teas and topical lotions and creams. Therefore, the FDA is working on the evaluation of regulatory policies related to cannabis and cannabis-derived ingredients. Read more 13-11-2019
‘Regulatory science to 2025’: live broadcast of post-consultation workshop Read more 12-11-2019
Recolha de lotes de medicamentos contendo ranitidina - Aditamento Circular Informativa n.º 171/CD - Na sequência da recolha e suspensão imediata da comercialização de vários lotes de medicamentos contendo Ranitidina, devido à deteção de uma impureza, N-Nitrosodimethylamine (NDMA), na substância ativa ranitidina, divulgada através da Circular Informativa N.º 143/CD/550.20.001, de 20/09/2019, foi recebida informação adicional, referente à decisão de suspensão do Certificado de Conformidade (CEP) R1-CEP 2007-320-Rev 02/Ranitidine hydrochloride Crystalline powder grade and D. C. grade do fabricante ORCHEV PHARMA PRIVATE LIMITED pelo European Directorate for the Quality of Medicines & Healthcare (EDQM), pelo que importa atualizar (informação a negrito) a lista de lotes de medicamentos alvo de recolha. Read more 11-11-2019
Novo alvo terapêutico pode abrir caminho para uma vacina universal contra a gripe Uma equipa de investigadores publicou um estudo que defende que uma mudança nos alvos terapêuticos pode criar a primeira vacina universal contra a gripe. O estudo publicado recentemente na revista The Lancet Infectious Diseases virou as atenções para uma proteína presente na superfície do vírus responsável por "orientar" o vírus para as células a infetar. A nova abordagem permitiu ativar com sucesso os anticorpos responsáveis pelo combate à gripe em ensaios clínicos de fase I, um resultado que os investigadores consideram ser promissor. Read more 08-11-2019
Publicado "Regulamento de gestão da disponibilidade do medicamento" O Regulamento de gestão da disponibilidade do medicamento foi aprovado - através da Deliberação N.º 93/CD/20019 que o anexa - e encontra-se já disponível na área Gestão da disponibilidade do medicamento. Read more 07-11-2019
General requirements for Plastics in Pharmaceutical Engineering The main material used in plant engineering is stainless steel. The variant 316L is regarded as standard; material incompatibilities of steel with the product play almost no role. This is different for plastics. Beside the leach-out, ageing and surface finishing, other quality features are often specified. Now, what are the general requirements for plastics in pharmaceutical plant engineering? Read more 06-11-2019
Updated annexes to the eSubmission roadmap published The following updated Annexes to the eSubmission Roadmap have been published to reflect current status of the practical implementation steps. Annex 2 to the HMA eSubmission Roadmap on the Mandatory use of eCTD for all procedure types and Annex 3 to the HMA eSubmission Roadmap on the implementation of mandatory VNeeS format for Veterinary regulatory submissions. Read more 05-11-2019
EU Delays Implementation of Eudamed Until May 2022 The Commission said it will only be possible to make Eudamed operational when the system is fully functional and has been independently audited. Read more 04-11-2019
MHRA Issues Brexit Guidance on Comparator Products for Generics Applicants may be able to compare their proposed medicine with a non-UK sourced comparator product, the agency said. Read more 31-10-2019
Announcement to all CEP holders for synthesised APIs regarding presence of nitrosamines EMA and CMDh have published documents on their websites, (EMA/189634/2019 and CMDh/404/2019), “Information on nitrosamines for marketing authorisation holders” which request marketing authorisation holders (MAH) to follow an investigation process described for synthesised APIs (other than sartans with a tetrazole ring). Although EDQM does not expect that this issue impacts many substances, it is now appropriate to expand the review to all other APIs manufactured from chemical synthesis for which CEPs have been granted. Read more 30-10-2019
PRAC recommendations on signals adopted at the 30 September-3 October 2019 PRAC meeting Read more 29-10-2019
CMDh practical guidance for Marketing Authorisation Holders of nationally authorised products (incl. MRP/DCP) in relation to the Art. 5(3) Referral on Nitrosamines Read more 28-10-2019
Questions and answers on implementation of the medical devices and in vitro diagnostic medical devices Regulations ((EU) 2017/745 and (EU) 2017/746) Read more 25-10-2019
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 October 2019 Read more 18-10-2019
Atualização da lista de grupos homogéneos e preços de referência No âmbito do Sistema de Preços de Referência, a lista dos grupos homogéneos e dos preços de referência unitários, a vigorar no 4.º trimestre de 2019, foi atualizada. Read more 17-10-2019
Ph. Eur. 2.4.20. Determination of elemental impurities A complete revision of Ph. Eur. chapter 2.4.20. Determination of elemental impurities has been published in Pharmeuropa. Read more 16-10-2019
Produtos Fitofarmacêuticos - Indicadores de Risco Harmonizados Foi publicada a Diretiva (UE) 2019/782 de 15 de maio que estabelece Indicadores de Risco Harmonizados com vista a medir os progressos realizados na redução dos riscos e dos efeitos negativos da utilização de pesticidas na saúde humana e no ambiente, tal como previsto na Diretiva (CE) n.º 2009/128/CE, do Parlamento Europeu e do Conselho, de 21 de outubro de 2009, relativa ao uso sustentável dos pesticidas. Read more 15-10-2019
Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 8-10 October 2019 Read more 14-10-2019
MHRA Will Require ‘UK Responsible Person’ for All Devices, IVDs The UK responsible person must ensure that an appropriate conformity assessment procedure has been carried out by the manufacturer. Read more 11-10-2019
Essential maintenance to computer applications on Wednesday 09-10-2019 PSUR and eSubmissions Web User Interface (to create the delivery file) will be unavailable between 07:00-09:00hrs (CEST) on Wednesday, 9 October 2019. However, the EMA gateway will remain available for all communities throughout and any files submitted during that time will be queued for processing when the work is complete. If you have any questions, please contact the IT Service Desk. Read more 08-10-2019
Registo de entidades no RNEC O Registo Nacional de Estudos Clínicos (RNEC) constitui uma plataforma eletrónica para registo e divulgação de estudos clínicos a decorrer em Portugal. Desta forma, o público em geral, os profissionais de saúde e investigadores terão acesso a informação sobre os ensaios clínicos com medicamentos de uso humano a decorrer em Portugal. Este desígnio só será possível com o envolvimento e contributo de todas as entidades que participam em ensaios clínicos. Read more 07-10-2019
Four-week limit for use of high-strength estradiol creams Read more 04-10-2019
FDA Cautions on Use of ‘Bayesian’ Statistics in Complex Trials Using Bayesian methods “can increase the chance of erroneous conclusions,” the agency says. Read more 03-10-2019
EMA website on Permitted Daily Exposure (PDE) limits The issue of cross-contamination has been addressed by authorities since the publication of the first edition of the EU GMP Guidelines. The EMA has compiled everything essential on health-based exposure limits and PDE limits on their website. Read more 02-10-2019
FDA publishes Q&A on Internal Standard Responses in Chromatography Bioanalysis In support of sponsors, applicants and research institutions, the FDA examines in more detail the variability of internal standards in analytics and their consequences. The authority has now published a document entitled "Evaluation of Internal Standard Responses During Chromatographic Bioanalysis: Questions and Answers". Read more 01-10-2019
Avaliação da presença de nitrosamina em medicamentos Circular Informativa Nº. 145/CD/100.20.200 de 27/09/2019 - No sentido de fornecer informação aos TAIM sobre as ações que eles devem executar, estão disponíveis no site da Agência Europeia dos medicamentos (EMA na sigla inglesa) e no site do Grupo de Coordenação para os procedimentos de reconhecimento mútuo e descentralizado, CMDh, documentos orientadores que devem ser seguidos. Read more 30-09-2019
Change of name of liposomal medicines at high risk of medication errors Read more 27-09-2019
Information on nitrosamines for marketing authorisation holders Read more 26-09-2019
UPDATE - Q&As on Variations Read more 25-09-2019
EDQM updates two Guidelines on the CEP procedure The updating of two important documents by the EDQM reflects the current practice of the CEP procedure. Read more about the competencies and responsibilities of the various bodies in the CEP application procedure and about the code of practice for assessors and inspectors. Read more 24-09-2019
EMA’s work on new veterinary regulation advances Read more 23-09-2019
Focused stakeholders consultation on revised draft PIC/S GMP Guide Annex 2A (Manufacture of Advanced Therapy Medicinal Products for Human Use) and Annex 2B (Manufacture of Biological Medicinal Substances and Products for Human Use) A draft revision of the PIC/S GMP Guide Annex 2 (Manufacture of biological medicinal substances and products for human use) has been prepared by the PIC/S Working Group on revision of Annex 2 established with WHO, led by Francesco Cicirello, Australia / TGA, and by the PIC/S Sub-Committee on GMDP Harmonisation, led by Paul Gustafson, Health Canada. Read more 20-09-2019
How to draft a direct healthcare professional communication Guidance for marketing authorisation holders on drafting direct healthcare professional communications (DHPCs) or 'dear Dr letters', including the template. Read more 19-09-2019
Biological medicine quality to receive major boost The Medicines and Healthcare products Regulatory Agency have released a Strategy for Pharmacopoeial Public Quality Standards for Biological Medicines update. Read more 18-09-2019
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. Read more 17-09-2019
EMA to review ranitidine medicines following detection of NDMA Read more 16-09-2019
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. Read more 13-09-2019
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). Read more 12-09-2019
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. Read more 11-09-2019
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 Read more 10-09-2019
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. Read more 09-09-2019
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. Read more 06-09-2019
Orchestra BioMed Receives CE Mark for Implantable Hypertension Treatment The principal investigator said the device has potential as a primary treatment for hypertension. Read more 05-09-2019
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. Read more 04-09-2019
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. Read more 03-09-2019
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. Read more 02-09-2019
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. Read more 30-08-2019
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. Read more 29-08-2019
White House Highlights ‘Red Flags’ for Illicit Fentanyl The manufacturing advisory identifies the various stages of illegal fentanyl manufacturing and distribution. Read more 28-08-2019
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. Read more 27-08-2019
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. Read more 26-08-2019
New measures to avoid potentially fatal dosing errors with methotrexate for inflammatory diseases Read more 23-08-2019
Questions and answers on the exemption from batch controls carried out on ATMPs imported into the European Union from a third country Read more 22-08-2019
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). Read more 21-08-2019
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. Read more 20-08-2019
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. Read more 19-08-2019
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 Read more 16-08-2019
EMA closed 15 August 2019 Read more 14-08-2019
How to detect Falsified Medicines Falsified medicines repeatedly occur in the supply chain. The MHRA now provides information on how to detect them. Read more 13-08-2019
What’s new in pharmacovigilance - QPPV Update - Issue 1 - 2019 Read more 12-08-2019
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. Read more 09-08-2019
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. Read more 08-08-2019
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. Read more 07-08-2019
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. Read more 06-08-2019
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”. Read more 05-08-2019
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. Read more 02-08-2019
Names of liposomal medicines to be changed to avoid medication errors Read more 01-08-2019
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. Read more 31-07-2019
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). Read more 30-07-2019
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 Read more 29-07-2019
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). Read more 26-07-2019
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. Read more 25-07-2019
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. Read more 24-07-2019
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. Read more 23-07-2019
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. Read more 22-07-2019
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. Read more 19-07-2019
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. Read more 18-07-2019
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. Read more 17-07-2019
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. Read more 16-07-2019
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. Read more 15-07-2019
EU and US reach a milestone in mutual recognition of inspections of medicines manufacturers Read more 12-07-2019
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. Read more 11-07-2019
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. Read more 10-07-2019
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. Read more 09-07-2019
Creams, Gels & Pastes redefined A revised version of the Ph. Eur. Monograph Semi-solid preparations for cutaneous application has been published in Pharmeuropa. Read more 08-07-2019
Medicine shortages: EU network takes steps to improve reporting and communication Read more 05-07-2019
Call for all sponsors to publish clinical trial results in EU database Read more 04-07-2019
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. Read more 03-07-2019
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. Read more 02-07-2019
Product-information templates Compliance with QRD template v10.1 Read more 01-07-2019
QRD product-information annotated template (English) version 10.1 - highlighted Read more 28-06-2019
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. Read more 27-06-2019
Temporary interim limits for NMBA, DIPNA and EIPNA impurities in sartan blood pressure medicines Read more 26-06-2019
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. Read more 25-06-2019
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. Read more 24-06-2019
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. Read more 21-06-2019
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 Read more 19-06-2019
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. Read more 18-06-2019
Leuprorelin-containing depot medicinal products Leuprorelin , See "List of the medicines affected by the referral (Annex I)", Article 31 referrals, Procedure started Read more 17-06-2019
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. Read more 14-06-2019
Two additional countries to benefit from EU-US mutual recognition agreement for inspections Read more 12-06-2019
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 Read more 11-06-2019
EMA closed 10 June 2019 EMA is closed from 18:30 on Friday 7 June until 7:30 on Tuesday 11 June 2019. Read more 07-06-2019
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. Read more 06-06-2019
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. Read more 05-06-2019
Consultation on draft guideline on quality requirements for medical devices in combination products Read more 04-06-2019
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. Read more 03-06-2019
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. Read more 31-05-2019
Withdrawal of marketing authorisations for fenspiride medicines Read more 30-05-2019
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. Read more 29-05-2019
EMA closed 30-31 May 2019 Read more 28-05-2019
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. Read more 27-05-2019
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. Read more 24-05-2019
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. Read more 23-05-2019
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”. Read more 22-05-2019
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. Read more 21-05-2019
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 May 2019 Read more 20-05-2019
FDA Lays Out Weight of Evidence Guidelines for Fetal Toxicity in Oncology The weight of evidence could include a review of existing literature. Read more 17-05-2019
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. Read more 16-05-2019
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). Read more 15-05-2019
Implementação das obrigações legais no que respeita aos dispositivos de segurança Read more 14-05-2019
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. Read more 13-05-2019
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. Read more 10-05-2019
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. Read more 09-05-2019
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 Read more 08-05-2019
European Medicines Agency closed 9 May 2019 Read more 07-05-2019
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. Read more 06-05-2019
Corrigendum to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices Read more 03-05-2019
Two additional countries to benefit from EU-US mutual recognition agreement for inspections Read more 02-05-2019
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
European Medicines Agency closed 1 May 2019 Read more 29-04-2019
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
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
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
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
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
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 closed 18-22 April 2019 Read more 16-04-2019
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
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 April 2019 Read more 12-04-2019
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
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
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
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
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
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
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
Regulatory information – 1.7% increase of fees from 1 April 2019 Read more 02-04-2019
Draft ICH guideline E19 on optimisation of safety data collection - Step 2b Read more 01-04-2019
20 years of sampling and testing of centrally authorised products: 1998 – 2017 Read more 29-03-2019
New EudraVigilance system improves reporting of side effects and detection of safety signals Read more 28-03-2019
Questions & answers: EU actions to prevent medicine shortages due to Brexit Read more 27-03-2019
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 Management Board: highlights of March 2019 meeting Read more 25-03-2019
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
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
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
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
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
ICH M10 on bioanalytical method validation Read more 15-03-2019
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
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 now operating from Amsterdam Read more 12-03-2019
Sterilisation of the medicinal product, active substance, excipient and primary container Read more 11-03-2019
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
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
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
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
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
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
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
Information – Withdrawal of the United Kingdom and EU rules on batch testing of medicinal products Read more 26-02-2019
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
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
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
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
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 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
Safety Features: Handling of Alerts The safety feature provisions enetered into force - How to report a falsified pack? Read more 13-02-2019
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
Falsified medicines: new rules to enhance patients' safety Read more 11-02-2019
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
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
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
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
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
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
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 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
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
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
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
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
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
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 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
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
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
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
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 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
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
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
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
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
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
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
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
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 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
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
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
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
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
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
Mobile scanning and other technologies in the labelling and package leaflet of centrally authorised medicinal products Read more 10-12-2018
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 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
Launch of the new EudraVigilance system: questions and answers from stakeholders Update Read more 05-12-2018
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
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
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
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
Questions and answers (version 12) - Safety features for medicinal products for human use Read more 27-11-2018
Qualification of non-genotoxic impurities Read more 26-11-2018
Non-clinical requirements for radiopharmaceuticals Read more 23-11-2018
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
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. Read more 21-11-2018
Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’ Read more 20-11-2018
Disabling and potentially permanent side effects lead to suspension or restrictions of quinolone and fluoroquinolone antibiotics Read more 19-11-2018
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
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
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
Circular nº 1/2018: Instrucción sobre excipientes Actualización de la información sobre excipientes en la información de medicamentos. Read more 13-11-2018
EU Health Policy Platform Holds Third Annual Meeting Read more 12-11-2018
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
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
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
Publicación de Informes de Posicionamiento Terapéutico Read more 06-11-2018
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
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
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
National information on MAH transfers Update Read more 30-10-2018
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
Training presentations on Active Substance Master File (ASMF) work sharing procedure New Read more 26-10-2018
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
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
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
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
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
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
EU authorities take further action in ongoing review of sartans: Zheijiang Huahai placed under increased supervision. Read more 16-10-2018
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 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
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
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: 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
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
Q&As on Pharmacovigilance Legislation Update Read more 04-10-2018
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 tracking tool: relocation to Amsterdam - Main milestones Read more 02-10-2018
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. Read more 01-10-2018
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
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
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
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
Portugal to also benefit from EU-US mutual recognition agreement for inspections Read more 21-09-2018
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 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
Member states contact points for translation review (v.6.11) Read more 18-09-2018
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
Update on review of valsartan medicines Read more 14-09-2018
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
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
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
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
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
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 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
Pre-notification check for type IA variations: ensuring the quality of veterinary type IA variation submissions Update Read more 03-09-2018
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. Read more 28-08-2018
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 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
Keeping medicines safe Keeping medicines safe How EMA monitors medicines once they are on the market Read more 23-08-2018
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
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
Launch of the new EudraVigilance system: questions and answers from stakeholders Update Read more 20-08-2018
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
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
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 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 procedural advice on changing the RMS Update Read more 10-08-2018
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
Electronic submission of Article 57(2) data: questions and answers Update Read more 08-08-2018
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
Best Practice Guide for the Reference Member State in the MRP/DCP Update Read more 06-08-2018
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
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
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
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
Claims relating to cosmetic products Read more 30-07-2018
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
IT systems unavailable from 27 to 30 July 2018 EMA website and online applications will be temporarily unavailable Read more 26-07-2018
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
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 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
Template for RMS change Read more 20-07-2018
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
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’s proactive publication of clinical data a success First report on unprecedented transparency policy shows high user satisfaction. Read more 17-07-2018
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
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 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
Brexit-related guidance for companies Read more 11-07-2018
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 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
Pre-authorisation guidance Read more 06-07-2018
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
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 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
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: 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 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
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 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
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 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
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
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 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
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. Read more 18-06-2018
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. Read more 15-06-2018
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. Read more 14-06-2018
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. Read more 12-06-2018
Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use June 2018 Read more 11-06-2018
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. Read more 07-06-2018
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. Read more 04-06-2018
List of safety concerns per approved Risk Management Plan (RMP) of active substances per product Update Read more 01-06-2018
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. Read more 30-05-2018
List of centrally authorised products requiring a notification of a change for update of annexes Update. Read more 28-05-2018
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. Read more 25-05-2018
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. Read more 24-05-2018
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. Read more 23-05-2018
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. Read more 22-05-2018
Targeted stakeholder consultation on duplicate marketing authorisations for biological medicinal products Read more 21-05-2018
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. Read more 18-05-2018
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. Read more 17-05-2018
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. Read more 16-05-2018
Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use May 2018 Read more 15-05-2018
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. Read more 14-05-2018
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. Read more 11-05-2018
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. Read more 10-05-2018
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. Read more 09-05-2018
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. Read more 08-05-2018
Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP Read more 07-05-2018
Evaluation of EMA fee system for the approval and monitoring of medicines: Public consultation launched today. Read more 04-05-2018
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). Read more 03-05-2018
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? Read more 02-05-2018
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’. Read more 30-04-2018
Updated rules for clinical development of vaccines EMA launches public consultation on revised guideline on clinical evaluation of vaccines. Read more 27-04-2018
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. Read more 26-04-2018
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. Read more 24-04-2018
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. Read more 23-04-2018
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. Read more 20-04-2018
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. Read more 19-04-2018
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? Read more 18-04-2018
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. Read more 17-04-2018
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. Read more 16-04-2018
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. Read more 13-04-2018
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. Read more 12-04-2018
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. Read more 11-04-2018
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. Read more 10-04-2018
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 Read more 09-04-2018
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? Read more 06-04-2018
MHRA GxP Data Integrity Definitions and Guidance for Industry MHRA has produced draft GxP data integrity guidance for industry and we welcome your comments. Read more 05-04-2018
Public consultation concerning the EU template for GMP non-compliance statement Deadline for comments: 15/05/2018 Read more 04-04-2018
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. Read more 03-04-2018
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. Read more 02-04-2018
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. Read more 29-03-2018
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. Read more 28-03-2018
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. Read more 27-03-2018
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. Read more 26-03-2018
January 2018 CMDh Minutes Read more 22-03-2018
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. Read more 21-03-2018
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. Read more 19-03-2018
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. Read more 16-03-2018
Additional Data requested for New Applications in the Mutual Recognition and Decentralised Procedures Read more 15-03-2018
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. Read more 14-03-2018
European Pharmacopoeia Reference Standards recently released 9 new Ph. Eur. Reference Standards (RS) were released in February 2018. Read more 13-03-2018
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. Read more 12-03-2018
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. Read more 05-03-2018
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. Read more 02-03-2018
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. Read more 28-02-2018
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. Read more 27-02-2018
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. Read more 26-02-2018
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. Read more 23-02-2018
Medical devices: UK notified bodies UK notified bodies listed under medical device directives. Read more 22-02-2018
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. Read more 21-02-2018
Highlights from the twelfth industry stakeholder platform on the operation of pharmacovigilance in the European Union Read more 20-02-2018
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. Read more 19-02-2018
Health-EU Newsletter - Assessing health technology in the EU: Commission proposes to reinforce cooperation amongst Member States Read more 16-02-2018
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
New Q&A on safety features concerning falsified medicines Version 9 Read more 14-02-2018
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. Read more 08-02-2018
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? Read more 07-02-2018
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). Read more 06-02-2018
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. Read more 05-02-2018
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. Read more 02-02-2018
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. Read more 01-02-2018
December 2017 CMDh Minutes Read more 31-01-2018
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». Read more 30-01-2018
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. Read more 29-01-2018
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. Read more 26-01-2018
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. Read more 25-01-2018
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. Read more 24-01-2018
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. Read more 23-01-2018
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. Read more 22-01-2018
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. Read more 19-01-2018
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. Read more 18-01-2018
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. Read more 17-01-2018
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. Read more 16-01-2018
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. Read more 15-01-2018
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. Read more 12-01-2018
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
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
MSs Recommendations on Extension Applications in Mutual Recognition and Decentralised Procedures Read more 09-01-2018
Human medicines highlights - January 2018 Read more 08-01-2018
PRAC recommendations on signals adopted at the PRAC meeting of 27-30 November 2017 Read more 05-01-2018
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
Pharmeuropa: Texts for comments Pharmeuropa issue 30.1 is now complete. Submit your comments until 31 March 2018. Read more 03-01-2018
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 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
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
Extension of pilot for splitting of MRP/DCPs Update on the "Extension of pilot for splitting of MRP/DCPs". Read more 27-12-2017
Annual Price Revision for the Generic Medicinal Products 2018 Binding Information Newsletter no. 171, from 22-12-2017. Read more 27-12-2017
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
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
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
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
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
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
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
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
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
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
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 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
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
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
Drug Safety Update - November 2017 Monthly PDF newsletter. Read more 27-11-2017
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
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
GVP Update 2017 There have been recent developments within EudraLex Volume 9 - Guidelines on good pharmacovigilance practices (GVP). Read more 22-11-2017
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
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
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
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
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
Guideline on good pharmacovigilance practices (GVP): Module VII – Periodic safety update report - Explanatory note Adopted Read more 14-11-2017
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
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
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
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 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 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. Read more 06-11-2017
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
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 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
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
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. Read more 27-10-2017
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. Read more 26-10-2017
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
PRAC recommendations on signals adopted at the 25-29 September 2017 PRAC meeting Adopted Read more 24-10-2017
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. Read more 23-10-2017
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 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
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 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
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
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 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
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
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
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
Minutes of the CAT meeting 12-14 July 2017 Read more 04-10-2017
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
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 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
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 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
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
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
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
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
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
European Medicines Agency guidance for applicants seeking scientific advice and protocol assistance Updated guidance. Read more 19-09-2017
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 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
Update - Questions and answers: Good manufacturing practice Read more 14-09-2017
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
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 Newsletter – Issue 63 Access the new edition of Infarmed Newsletter. Read more 11-09-2017
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
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
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
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
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
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
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). Read more 30-08-2017
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
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
Revised Ph. Eur. Chapter Table

Regulatory News

DAILY RELEVANT REGULATORY NEWS

Good manufacturing practice

EMA regular press briefing on COVID-19

Nova edição do Boletim de Farmacovigilância

COVID-19 vaccines and medicines: updates for September 2021

Consultation on Amendments on Pharmacovigilance Activities

Deliberação n.º 956/2021

Deliberação n.º 946/2021

Increase in manufacturing capacity for COVID-19 vaccine from BioNTech/Pfizer

Final EMA Guideline: Quality Requirements for Combination Products

ICH publishes Guideline Q13 on Continuous Production

Comunicado da Agência Europeia de Medicamentos: avaliação de pedido de utilização de dose de reforço da vacina Comirnaty

ECDC and EMA highlight considerations for additional and booster doses of COVID-19 vaccines

EMA and FDA update Principles for Parallel Scientific Advice in the Marketing Authorization Process

What is Similarity?

Increase in vaccine manufacturing capacity for COVID-19 vaccines from BioNTech / Pfizer and Moderna

FDA Approves First COVID-19 Vaccine

First monoclonal antibody treatment for COVID-19 approved for use in the UK

Audit Trail-Deviations in the course of Inspections

EMA starts evaluating use of RoActemra in hospitalised adults with severe COVID-19

Northern Ireland: EU continues to look for Solutions - with interesting Forms of Documents

Human medicines highlights - August 2021

Comunicação conjunta EMA e ECDC sobre COVID-19: EMA e ECDC recomendam vacinação em todos os cidadãos elegíveis

Boas Práticas de Distribuição e Farmacovigilância

Sistema europeu de ensaios clínicos lançado em janeiro

Parecer sobre vacinação universal de pessoas entre os 12 e 15 anos

Novo serviço de alertas de tecnologias de saúde

Relatório de Farmacovigilância: monitorização da segurança das vacinas contra a COVID-19 em Portugal

Aviso de indisponibilidade de aplicações

Updated Templates for Reporting Nitrosamine Contamination to Regulatory Authorities

EMA starts evaluating the use of Kineret in adult COVID-19 patients at increased risk of severe respiratory failure

International regulators work towards alignment on development and authorisation of second-generation COVID-19 vaccines

EMA and ECDC update on COVID-19

Q&A Document on Nitrosamine Impurities Updated

Comirnaty e Spikevax: possível ligação a casos muito raros de miocardite e pericardite

Brexit: EU defines possible Solutions for Northern Ireland

Pharmeuropa 33.3 just released

Nitrosamine impurities

Novo Regulamento dos Dispositivos Médicos: ficha informativa para mandatários, importadores e distribuidores

EMA publishes Q&A Document about Parallel Distribution

First cell-based gene therapy to treat adult patients with multiple myeloma

Aplicação do Regulamento dos Dispositivos Médicos (RDM) na parte que se refere à investigação clínica de dispositivos

Novo Regulamento dos Dispositivos Médicos: ficha informativa para fabricantes

Novo Regulamento dos Dispositivos Médicos: modelo para a implementação, passo a passo

Ph. Eur. General Notices Chapter - New Structure and Content

COVID-19 vaccines: update on ongoing evaluation of myocarditis and pericarditis

International regulators and WHO address need to boost COVID-19 vaccine confidence

Novo Regulamento dos Dispositivos Médicos: novas características

EMA raises awareness of clinical care recommendations to manage suspected thrombosis with thrombocytopenia syndrome

Relatório: Vacinas para a COVID-19 - Reações adversas em Portugal

Novo Regulamento dos Dispositivos Médicos: está preparado?

The GMP Requirements for Supplier Qualification

Questions & Answers on Good Distribution Practices (GDP) - Part 4

First COVID-19 vaccine approved for children aged 12 to 15 in EU

Insufficient data on use of inhaled corticosteroids to treat COVID-19

Comunicado de Imprensa - Novo Regulamento Europeu dos Dispositivos Médicos

APIC: Update of the Template for Potential Nitrosamine Contaminations

Vaxzevria: Recomendações adicionais relativamente à ocorrência muito rara de coágulos sanguíneos invulgares com diminuição do nível de plaquetas (síndroma de trombose e trombocitopenia, TTS)

First gene therapy to treat children with rare inherited neurological disease

EMA procedural advice for medicinal products intended exclusively for markets outside the European Union in the context of co-operation with the World Health Organisation (WHO)

GMP: Are there "planned" Deviations?

Notice to manufacturers and authorised representatives on the impact of genetic variants on SARS-COV-2 in vitro diagnostic medical devices

CMDh practical guidance for Marketing Authorisation Holders of nationally authorised products (incl. MRP/DCP) in relation to the Art. 5(3) Referral on Nitrosamines

MHRA establishes own GMDP Database

Revised monograph Water for injections published for public comment in Pharmeuropa

Vacinas para a COVID-19: Relatório sobre reações adversas em Portugal

International regulators and WHO call for wider public access to clinical data

Revision of the PIC/S Guidelines for ATMPs and Biological Medicinal Products

EMA starts rolling review of COVID-19 Vaccine (Vero Cell) Inactivated

EMA starts evaluating use of COVID-19 vaccine Comirnaty in young people aged 12 to 15

A new collaboration between SNOMED International and ICH promotes seamless data exchange in support of public health

Factsheet for Class I - Medical Devices

Unidade de Farmacovigilância de Braga inicia atividades

Questions & Answers on Good Distribution Practices (GDP) - Part 3

Banco Farmacêutico apela à doação de medicamentos

COVID-19 Vaccine Janssen: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets

The Draft Principles of ICH E6 Good Clinical Practice (GCP) now available

EMA starts review of VIR-7831 for treating patients with COVID-19

COVID-19 Vaccine Janssen: assessment of very rare cases of unusual blood clots with low platelets continues