DAILY RELEVANT REGULATORY NEWS
Rastreabilidade de stocks de medicamentos para COVID-19Em 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
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COVID-19 and vaccines: Equitable access to vaccination must be ensuredHow 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
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Public-health advice during COVID-19 pandemicThe 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
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Global regulators highlight key role of healthcare professionals in fostering confidence in COVID-19 vaccinesEMA 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
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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
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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
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EMA receives application for conditional marketing authorisation of COVID-19 Vaccine AstraZenecaEMA 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
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Extra dose from vials of Comirnaty COVID-19 vaccineEMA’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
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EMA recommends COVID-19 Vaccine Moderna for authorisation in the EUEMA 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
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Brexit: the United Kingdom's withdrawal from the European UnionThe 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
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EMA organises a second public meeting about the new COVID-19 vaccinesEMA 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
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European Commission authorises first safe and effective vaccine against COVID-19
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EMA Management Board: highlights of December 2020 meetingThe 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
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Update on assessment of marketing authorisation application for Moderna’s mRNA-1273 COVID-19 vaccineOver 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
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Update on assessment of the BioNTech and Pfizer BNT162b2 vaccine marketing authorisation applicationEMA’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
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Comissão Europeia disponibiliza Q&A sobre vacinas COVID-19A 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
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COVID-19 vaccines: studies for approvalThe 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
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infoDM em vídeo: nova ferramenta de pesquisa pública de dispositivos médicosJá 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
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Estratégia conjunta prepara futuro da rede de agências reguladoras de medicamentos da UE até 2025Como 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
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EMA publica orientações sobre flexibilização quanto à informação do medicamento (Folheto Informativo e Rotulagem) para as vacinas contra a COVID-19No 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
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Coronavirus: Commission presents “Staying safe from COVID-19 during winter” strategy
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EMA receives application for conditional marketing authorisation of COVID-19 mRNA vaccine BNT162b2EMA 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
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EMA - Public Meeting on COVID-19 VaccinesNo 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
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Update on remdesivir - EMA will evaluate new data from Solidarity trialEMA 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
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EMA publica documento sobre critérios de desenvolvimento e avaliação clínica das vacinas contra a COVID-19No 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
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Coronavirus: Commission steps up actions on testing with a recommendation on rapid antigen tests and support to increase testing capacity
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Antimicrobial resistanceThe 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
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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
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Nitrosamines: EMA aligns recommendations for sartans with those for other medicinesEMA’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
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COVID-19 vaccines: release of guidelines critical for co-ordinated independent batch control by EU OMCLsThe 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
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Consulte a nova infografia sobre o SIDMSistema de Informação para Dispositivos Médicos (SIDM), desenvolvido no âmbito do programa SIMPLEX, foi lançado a 2 de novembro de 2020. Read more
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Novo Sistema de Informação para Dispositivos Médicos (SIDM): assista ao vídeoO 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
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Novo sistema de informação para dispositivos médicosO 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
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Labelling and Packaging Flexibilities for Covid-19 VaccinesThe 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
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Extra transparency measures for COVID-19 vaccines and therapeuticsThe 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
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PRAC recommendations on safety signalsEach 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
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Strengthening global collaboration on COVID-19 real-world evidence and observational studies
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EMA starts second rolling review of a COVID-19 vaccineEMA’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
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EU regulators fully uphold transparency and independence standards for COVID-19 treatments and vaccinesThe 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
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EMA starts first rolling review of a COVID-19 vaccine in the EUEMA’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
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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 oxigénioO 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
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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
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PRAC recommendations on safety signalsEach 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
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EFPIA statement on the European Regulatory Network Strategy to 2025EFPIA 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
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AstraZeneca Resumes Phase 3 COVID-19 Vaccine Trial in UKAstraZeneca 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
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Comunicado de Imprensa - Suspensão momentânea de vacina para COVID-19De 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
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Brexit: How to import Medicines into UKThe 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
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Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) from 1 January 2021Pharmacovigilance system requirements from 1 January 2021 Read more
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EU: Checklist for Brexit PreparationThe European Commission has published a 'Brexit Readiness Checklist' for companies doing business with the UK. Read more
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PIC/S publishes Q&A document on Health Based Exposure Limits and Cross-ContaminationIn 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
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GDP Monograph for Active Substances: Interactive PDF now availableIn 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
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Coronavirus: Commission approves funding for training of healthcare professionals in intensive care skills
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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
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Nitrosamines risk assessment: update for CEP holdersIn 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
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Estratégia da Rede de Agências Europeias de Medicamentos em consulta públicaA 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
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Evaluation of the medicines for rare diseases and children legislationOn 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
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INFORMATION ON NITROSAMINES FOR MARKETING AUTHORISATION HOLDERSCMDh 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
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The E2B(R3) User Guide v1.1 Available Now on the ICH WebsiteThe 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
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FIP atualiza relatório sobre vacinação nas farmáciasA 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
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Brexit: Sponsors Need to Establish an EU-QPSince 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
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The ICH S11 introductory training presentation available now on the ICH websiteThe 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
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Leuprorelin-containing depot medicinal products.Leuprorelin , Daronda,Depo-Eligard,Eligard,Eligard Depot,Eligard Mensua,Eligard Semestral,Eligard Trimestral,Elityran 1 Month Depot (Dps),Elityran 3 Month Depot (Dps),Enanton Depot Dual,Enanton Depot Set,Enantone,Enantone L.P,Enantone Lp,Enantone Monats-Depot,Ginecrin Depot,Klebrocid 3-Monats-Depot,Klebrocid Depot Zweikammerspritze,Leptoprol,Lerin,Leugon,Leuprex 3,Leuprol,Leuprolin Ratiopharm,Leuprone 1-Monatsdepot,Leuprone 3-Monatsdepot,Leuprorelin 1-Month Depot Gp-Pharm,Leuprorelin Hexal,Leuprorelin Sandoz,Leuprorelina Gp-Pharm,Leupro-Sandoz 1-Monats-Depot,Leupro-Sandoz 3-Monats-Depot,Leuprorelina Trimestral Sandoz,Leuprostin,Leuproreline Sandoz,Lucrin,Lucrin Depot,Lucrin Pds Depot,Lucrin Pds Depot 1 Maand,Lucrin Pds Depot 3 Maanden,Lucrin Pds Depot 6 Maanden,Lupron Depo,Lutrate 1 Month Depot,Lutrate 3 Month Depot,Lutrate Depo,Lutrate Depot,Lutrate Depot Trimestral,Politrate,Politrate Politrate Depot,Procren Depot,Procren Depot Pds,Procrin Mensual,Procrin Semestral,Procrin Trimestral,Prostap 3 Dcs,Prostap 6 Dcs,Prostap Sr Dcs,Prostaplant,Sixantone,Trenantone,Trenantone-Gyn,Zeulide,Елигард,Лутрат Депо, Article 31 referrals, CMDh final position, 24/06/2020, 31/07/2020 Read more
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UK Group Receives CE Mark for COVID-19 Rapid Antibody TestUK diagnostics company Abingdon Health has received a CE Mark for a COVID-19 antibody test that delivers results in 20 minutes. Read more
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Guidance for medicine developers and companies on COVID-19The 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
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EMA starts review of dexamethasone for treating adults with COVID-19 requiring respiratory supportEMA 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
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CHMP's Assessment Report on Nitrosamines publishedOn 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
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Pharmacovigilance Audits and Inspections during COVID-19The 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
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Covid-19: Handling of Marketing AuthorisationsThe 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
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Regulatory Authorities worldwide work more closely together because of COVID-19The 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
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Infarmed e restantes agências de medicamentos europeias juntas no combate à COVID-19Os 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
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EMA finalises opinion on presence of nitrosamines in medicinesEMA’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
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Distant Assessment leads to GMP Non-Compliance ReportMany 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
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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
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Impact of COVID-19 on EudraVigilance Reporting and LabelingThe 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
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New GDP Monograph for Active Substances publishedThe 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
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First COVID-19 treatment recommended for EU authorisationEMA’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
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Recommendations on medication errorsIn 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
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Nitrosamine impuritiesIn 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
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European Commission, EMA and FDA agree new priorities to strengthen their collaboration on medicinesSenior 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
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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
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International regulators stress value of safe and effective vaccinesEMA 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
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Remote GCP InspectionsThe 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
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Follow-up activities after Pharmacovigilance InspectionsEMA´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
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EDQM provides COVID-19 vaccine developers with free access to quality standards applicable in EuropeThe 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
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EU Member States report illegal and ineffective disinfectantsSeveral 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
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Practical guidance of the CMDh for facilitating the handling of processes during the COVID-19 crisis
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Derogation for Process Validation due to Covid-19Europe 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
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COVID-19: reminder of the risks of chloroquine and hydroxychloroquineEMA 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
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European medicines regulatory network fully mobilised in fight against COVID-19The 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
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Prospective dialogue between developers and regulators makes for better evidence generationEMA, 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
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EMA commissions independent research to prepare for real-world monitoring of COVID-19 vaccinesEMA 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
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Resposta à COVID-19 aprovada em Assembleia Mundial da SaúdeA 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
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Global regulators commit to cooperate on observational research in the context of COVID-19Regulators 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
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What Marketing Authorisation Holders need to know now about their RegistrationsOn 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
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Update of EU recommendations for 2020/2021 seasonal flu vaccine compositionEMA 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
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Máscaras: normas aplicáveis e tipologiaCom 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
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USP´s Quality Considerations for Medical CannabisAuthors 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
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EMA recommends expanding remdesivir compassionate use to patients not on mechanical ventilationEMA’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
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Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19In 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
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Infarmed lança infografias alertando para a importância da notificação de reações adversas em doentes com COVID-19O 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
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EMA starts rolling review of remdesivir for COVID-19EMA’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
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New EU/EMA planned Actions in the Context of the COVID-19 PandemicThe European Medicines Agency EMA has published three press releases on current EU/EMA activities in the context of the COVID-19 pandemic. Read more
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Guidance for medicine developers and companies on COVID-19The 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
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Avaliação da presença de nitrosaminas - Adiamento do prazo para submissão e perguntas frequentesConforme 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
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EMA establishes task force to take quick and coordinated regulatory action related to COVID-19 medicinesAs 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
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Nova edição da newsletter com resumo da informação da área COVID-19Está disponível nova edição da newsletter com o resumo da informação mais recentemente publicada na área COVID-19. Read more
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Ph. Eur. launches a public consultation on a new general chapter for the analysis of N-NitrosaminesThe 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
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EU authorities agree new measures to support availability of medicines used in the COVID-19 pandemicThe 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
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Commission postpones application of the Medical Devices Regulation to prioritise the fight against coronavirus
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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
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Regulatory guidance for medical devicesCheck 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
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Information package for certificates of medicinal products issued by the European Medicines Agency
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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
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EU GMP Annex 21 finally publishedOn 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
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Código de Conduta nos circuitos de distribuição e venda de produtos fitofarmacêuticosA 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
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Guidance to sponsors on how to manage clinical trials during the COVID-19 pandemicThe 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
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Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure
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Notice to stakeholders ´Withdrawal of the United Kingdom and EU rules for medicinal products for human and veterinary use"
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CMDh Guidance Document on the Numbering System for the Procedures for Mutual Recognition and Decentralised
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Rastreabilidade de stocks de medicamentos para COVID-19 - formato de reporteNa 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
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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 )
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Questions and answers (version 17) - Safety features for medicinal products for human use
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CMDh practical guidance for Marketing Authorisation Holders of nationally authorised products (incl. MRP/DCP) in relation to the Art. 5(3) Referral on Nitrosamines
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Update on nitrosamines in EU medicinesEU and national authorities are continuing their work to prevent and manage the presence of nitrosamine impurities in EU medicines. Read more
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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
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Medicines: apply for a parallel import licenceHow to get a parallel import licence for your medicine in the UK, including pharmacovigilance requirements and submitting your application. Read more
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QbD for TDS: FDA´s new draft guidanceThe FDA published a draft guideline "Transdermal and Topical Delivery Systems - Product Development and Quality Considerations". Read more
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Draft Annex 1: New Requirements for Lyophilization?Will the revised Annex 1 introduce new GMP requirements for lyophilized products? Read more
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FDA Revises Guidance on Electronic Drug SubmissionsThe 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
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Second joint targeted stakeholders' consultation on the revision of Annex 1, on manufacturing of sterile medicinal products, of the PIC/S – EU GMP Guide
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ICH S5(R3) reaches Step 4 of the ICH ProcessThe 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
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Implementation of risk assessment requirements to control elemental impurities in veterinary medicinal products
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Post-Brexit UK to Overhaul Medical Device AuthorityThe new legislation would empower the health department to impose monetary penalties as an alternative to criminal prosecution. Read more
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FDA Guidance Seeks to Speed Reviews of Biosimilars for Fewer Conditions of UseAs 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
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Formulário eletrónico para avaliação da presença de nitrosamina em medicamentoConforme 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
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New GMP Guidance for Marketing Authorisation HoldersAfter 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
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UK Offers Grace Period for Sudden Notified Body WithdrawalsSome 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
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UK Waves Goodbye to EU as Transition Period BeginsThe 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
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Quality of medicines questions and answers: Part 1These 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
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EMA to support development of vaccines and treatments for novel coronavirusTo 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
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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
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UK withdrawal from the EU on 31 January 2020The 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
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Falta de medicamentos agrava-se na EuropaO Grupo Farmacêutico da União Europeia (PGEU) está a acompanhar o fenómeno de escassez de medicamentos em vários países europeus. Read more
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Report on public consultation on the 'Electronic product information for human medicines in the European Union - draft key principles'
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SCCS - Read the new factsheet: "The SCCS Guidance on the safety assessment of nanomaterials in cosmetics"
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FDA Announces Plan for Electronic Orphan Drug Designation SubmissionsThe FDA plans to allow sponsors to submit orphan drug designation requests electronically later this year. Read more
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Produtos fitofarmacêuticos - Classificação harmonizada de substâncias ativasA 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
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European Medicines Agency’s privacy statement for the EMA Account Management system
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Procedural advice for orphan medicinal product designation: Guidance for sponsors
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Detailed guide regarding the EudraVigilance data management activities by the European Medicines Agency
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MedTech Europe Renews Alarm Over MDR TransitionTime 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
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EMA/CHMP publishes new Q&A Document on Comparability Considerations for ATMPsThe 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
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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
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Disponível webservice para notificação de faltas de medicamentosConforme previsto no Regulamento de Gestão da Disponibilidade do Medicamento, o webservice para comunicação automática das faltas de medicamentos está disponível. Read more
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Ranitidine Can Generate NDMA Under Storage Conditions, Lab SaysRanitidine can generate N-nitrosodimethylamine (NDMA) when stored at higher temperatures, a research laboratory has found, raising new safety concerns. Read more
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Orientações europeias dirigidas a fabricantes de dispositivos médicos da classe INo 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
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Pharmeuropa 32.1 just releasedAll 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
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Ranitidine Can Generate NDMA Under Storage Conditions, Lab SaysRanitidine can generate N-nitrosodimethylamine (NDMA) when stored at higher temperatures, a research laboratory has found, raising new safety concerns. Read more
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Canada Releases Final Guidance on Software as a Medical DeviceHealth 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
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New symbols for medical device label now available on the ISO websiteIn 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
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ISO Issues Risk Management Standard for DevicesThe International Organization for Standardization (ISO) has released a standard for device manufacturers for assessing and controlling potential medical device hazards. Read more
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Revisão Anual de Preços - 2020Revisão Anual de Preços de Medicamentos Genéricos e Não Genéricos_2020 Read more
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Trump Administration takes historic steps to lower U.S. prescription drug pricesPresident 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
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4-year overview of pharmacovigilance activities in the EU shows robust and effective medicines safety systemA 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
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European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
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Apply for a licence to market a medicine in the UKHow to license a medicine for sale in the UK and Europe, including applications through national, centralised and decentralised procedures. Read more
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VICH GL58 stability testing of new veterinary drug substances and medicinal products in climatic zones III and IV - First version
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Outcome of the 165th European Pharmacopoeia CommissionDuring 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
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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
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EMA update on metformin diabetes medicinesEMA 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
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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
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FDA Issues Guidance on Transdermal and Topical Drug Delivery SystemsThe 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
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European authorities working to avoid shortages of medicines due to Brexit – Questions and answers
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ICH Q12 adoptedThe 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
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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 Novemver 2019At 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
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Questions and answers on “Information on nitrosamines for marketing authorisation holders”
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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 brexitA 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
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Final Guideline on CCP for ATMPs publishedIn 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
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Falsified Medicines: New EU Aide Memoire for GDPThe 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
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Novo portal e novo protocolo de cedência de informaçãoA 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
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Information for the package leaflet regarding ethanol used as an excipient in medicinal products for human use
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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
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Commission report on the national and European Medicines Agency experience regarding the list of medicines for human use subject to additional monitoring
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Companies need to improve communication of hazardous substances in productsA 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
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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).
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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.
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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.
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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.
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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.
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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.
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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?
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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.
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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.
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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.
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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.
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PRAC recommendations on signals adopted at the 30 September-3 October 2019 PRAC meeting
Read more
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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
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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
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 October 2019
Read more
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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.
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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.
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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.
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Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 8-10 October 2019
Read more
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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.
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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.
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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.
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FDA Cautions on Use of ‘Bayesian’ Statistics in Complex Trials
Using Bayesian methods “can
increase the chance of erroneous conclusions,” the agency says.
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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.
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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".
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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.
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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.
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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.
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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.
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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.
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Aprovada lista dos grupos homogéneos e dos preços de referência unitários - 4.º trimestre de 2019
A lista dos Grupos Homogéneos e dos preços de
referência unitários a vigorar no 4.º trimestre de 2019 foi aprovada.
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Novo regulamento para gerir disponibilidade de medicamentos em Consulta Pública
O Infarmed colocou em Consulta Pública um novo projeto de
regulamento para gerir a disponibilidade de medicamentos, um documento que vem
definir as regras e procedimentos para notificação de faltas ou ruturas de
medicamentos, bem como as obrigações dos titulares de autorizações de
introdução no mercado, dos distribuidores grossistas e farmácias.
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The ICH E17 Guideline training materials available now on the ICH website
The ICH E17 Guideline on
General Principles for Planning and Design of Multi-Regional Clinical Trials
was finalised under Step 4 in November 2017. This Guideline provides guidance
on general principles on planning/designing Multi-Regional Clinical Trial
(MRCT).
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Track & Trace: Still ongoing issues
It has hardly worked out anywhere: the
falsification protection project has not been properly adapted EU-wide and
discontentment is spreading amongst pharmacists.
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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
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FDA Offers Advice on Benefit-Risk Considerations for Device Submissions
“The continuous, robust
generation of evidence throughout the premarket and postmarket setting … is
important to continuously refine our understanding of how medical devices are
used and perform,” the agency said.
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Amazon vende milhares de produtos inseguros ou proibidos
De acordo com uma investigação recente, a Amazon está a vender
pelo menos 4.152 produtos que foram incorretamente identificados, proibidos ou
declarados como inseguros pelas autoridades nacionais.
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Orchestra BioMed Receives CE Mark for Implantable Hypertension Treatment
The principal investigator said the device has
potential as a primary treatment for hypertension.
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EMA publishes first two Guidances on Drug Shortages
The European Medicines Agency (EMA) and
the Heads of Medicines Agencies (HMA) published two guidance documents which
can be seen as foundation for a long way to diminish shortages of medicinal
products.
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PhRMA Applauds FDA’s New Review Template for New Drug, Biologic Applications
PhRMA said it “strongly
encourages” the FDA’s new “integrated review process,” which combines
assessments by the agency’s different disciplines into a single document for
new drug applications and efficacy supplements.
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Global public meeting on draft ICH guideline on clinical trials
The ICH E8 guideline sets
out general scientific principles for the conduct, performance and control of
clinical trials. In recent years, clinical trials have undergone a radical
transformation with a wider range of both trial designs and data sources being
used in drug development. Therefore, ICH initiated a revision of the E8
guideline to address all the aspects that were not covered by the current
version of the guidance.
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Hormone replacement therapy (HRT): further information on the known increased risk of breast cancer with HRT and its persistence after stopping
New data have confirmed
that the risk of breast cancer is increased during use of all types of HRT,
except vaginal estrogens, and have also shown that an excess risk of breast
cancer persists for longer after stopping HRT than previously thought.
Prescribers of HRT should discuss the updated total risk with women using HRT
at their next routine appointment.
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Statement on the agency’s ongoing efforts to resolve safety issue with ARB medications
Protecting patients is the FDA’s highest
priority, and Americans can be confident in the quality of the products the
agency approves. The recent Angiotensin II Receptor Blocker (ARB) recalls have
deeply concerned patients, the medical community, the agency and international
regulatory bodies. The FDA is aware many patients rely on ARB medicines, and we
are concerned about the presence of nitrosamine impurities in these drugs.
Millions of people benefit from the high-quality products that the FDA
regulates, and the U.S. has the most robust drug supply in the world, with
strict standards for safety, effectiveness and quality.
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White House Highlights ‘Red Flags’ for Illicit Fentanyl
The manufacturing advisory
identifies the various stages of illegal fentanyl manufacturing and
distribution.
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What are suitable Cycles for Re-Qualification?
With the revision of Annex 15 in October
2015, the topic of requalification has become more important. Time intervals
for the assessment of the equipment with regard to the qualification status and
for the requalification itself should be justified. Criteria for the assessment
should be defined. This is sometimes difficult. Chapter 9 of the revised ISPE
Baseline No 5 Commissioning & Qualification of June 2019 on the periodic
review can be helpful here.
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U.S. Urges EU to Delay Implementing EU MDR/IVDR by Three Years
The letter highlights the
lack of notified bodies in the EU to perform certification activities under the
MDR/IVDR.
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New measures to avoid potentially fatal dosing errors with methotrexate for inflammatory diseases
Read more
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Questions and answers on the exemption from batch controls carried out on ATMPs imported into the European Union from a third country
Read more
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What is a Combination Product?
The FDA released a final guidance on postmarketing safety reporting for combination products to further clarify what a combination product is and how applicants can comply with the rules on postmarketing safety reporting requirements (PMSR).
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Alterações ao Estatuto do Medicamento reforçam regulação e supervisão no circuito do medicamento
Entrou em vigor o Decreto-Lei n.º 112/2019, de 16 de agosto, que constitui a décima segunda alteração ao Decreto-Lei n.º 176/2006 de 30 de agosto, diploma que aprova o denominado Estatuto do Medicamento.
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EMA/FDA analysis shows high degree of alignment in marketing application decisions between EU and US
EMA and the US Food and
Drug Administration (FDA) are aligned in more than 90% of marketing
authorisation decisions for new medicines.
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Decreto-Lei n.º 112/2019 - Diário da República n.º 156/2019, Série I de 2019-08-16123962150
Altera o regime jurídico dos medicamentos de uso humano
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How to detect Falsified Medicines
Falsified medicines
repeatedly occur in the supply chain. The MHRA now provides information on how
to detect them.
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Updated reminder on the working documents provided within the eCTD submissions
As per the structure of the
eCTD, the product information should be provided in PDF format within Module
1.1.3. However, occasionally it is necessary to provide, in addition to the PDF
requirement, product information or the Module 2 documents in Word format.
These files should be provided outside of the eCTD structure, in a separate
folder called xxxx-workingdocuments on the same submission zip package as the
eCTD.
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Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) in a no-deal Brexit
Pharmacovigilance system
requirements if there is a no-deal Brexit.
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11 new reference standards and 28 replacement batches released in July 2019
The EDQM announces the availability of:
11 new Ph. Eur. reference standards; 28 replacement batches for Ph. Eur.
reference standards. Information on reference standards removed from catalogue.
Information on change of sales units. Information on changes of storage /
shipping conditions. Information on reference standards currently out of
stock.
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Is the Audit Trail Review required for Electronic Health Records?
MHRA´s GCP inspectors have
recently seen various types of Electronic Health Records (eHRs) during their
investigator site inspections and in several cases they have given major
findings.
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Governo aprovou alterações ao Estatuto do Medicamento
O Governo aprovou em Conselho de Ministros uma
alteração ao Decreto-Lei n.º 176/2006, que estabelece o regime jurídico dos
medicamentos de uso humano, no sentido de “minimizar as situações de rotura de
medicamentos no território nacional”.
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Comissão Europeia disponibiliza novos documentos para implementação dos regulamentos europeus de dispositivos médicos e para diagnóstico in vitro
A Comissão Europeia tem vindo a disponibilizar vários
documentos orientadores para facilitar a implementação dos novos regulamentos
europeus dos Dispositivos Médicos (DM) e dos Dispositivos Médicos para
Diagnóstico In Vitro (DIV). Dirigidos aos diferentes intervenientes do
ecossistema dos DIM e DIV, estes documentos, alguns dos quais em versão
traduzida para português, são disponibilizados pelo Infarmed, na área do site
dedicada à implementação dos novos regulamentos.
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How to quickly find out about FDA requirements for Medical Devices?
In the USA, medical devices
are regulated within the FDA by the Center for Devices and Radiological Health
(CDRH). How can one quickly familiarize oneself with the topic of "medical
devices" or stay up to date? For this purpose, the FDA offers an own
website: CDRH Learn.
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Cursos Eudravigilance no Infarmed em novembro de 2019
Vai decorrer, nas instalações do Infarmed, nos dias 18
a 20 de novembro de 2019, o curso "ISO/ICH E2B(R3) Individual Case Safety
Reporting in the EU: Hands-on Training Course using the EudraVigilance
System", promovido pela Drug Information Association (DIA).
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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
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Implementação dos regulamentos de DM e DIV - Atualização das orientações da Comissão Europeia
A Comissão Europeia disponibilizou novos documentos
orientadores que visam esclarecer e facilitar a implementação dos Regulamentos
Europeus dos Dispositivos Médicos (DM) e dos Dispositivos Médicos para
Diagnóstico In Vitro (DIV).
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Resolução da Assembleia Legislativa da Região Autónoma da Madeira n.º 23/2019/M - Diário da República n.º 141/2019, Série I de 2019-07-25
Apresenta à Assembleia da República a proposta de lei
que procede à primeira alteração ao Decreto-Lei n.º 124/2018, de 28 de
dezembro, que clarifica as regras aplicáveis à comparticipação de medicamentos
e dispositivos médicos pelo sistema de proteção social dos trabalhadores em
funções públicas.
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Safety Features - how is it progressing?
The MHRA will be issuing a
series of blog posts regarding the implementation of the FMD over the next few
months. The first post looks at the robustness of incoming checks.
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10th Edition of Ph. Eur.: CEP holders are invited to update their applications
CEP holders are invited to update their
applications according to the revised monographs that will be implemented on
the 1st of January 2020 in the 10th Edition of the Ph. Eur., and to follow the
instructions given in the document.
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Essential maintenance to computer applications
Essential maintenance is
scheduled to be carried out to SPOR data services: Referential Management
Services (RMS) and Organisations Management Services (OMS) between between
19:00hrs (CEST) and 20:00hrs (CEST) on Tuesday, 23 July 2019. Applications
consuming real-time RMS data (PSUR Repository, MMS-e, EudraGMDP, EudraCT, EU
PAS (ENCepp), and eAF) will be affected intermittently during this time. Should
you have any questions please contact the EMA IT Service Desk.
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Aviso de indisponibilidade do portal SIATS e das plataformas SMUH-AIM e SMUH-ALTER
Informa-se que, por motivos de manutenção, o portal
SIATS e as plataformas SMUH-AIM e SMUH-ALTER estarão indisponíveis entre as 9h
e as 12h do dia 22/07/2019.
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Certification procedure: revised documents July 2019
The EDQM has revised the following
documents to reflect current practice and clarify a couple of items: Terms of
reference and Code of Practice for the Certification procedure.
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Update of the borderline guideline on medical devices
At what point is a
medical device to be considered a medical device in Europe? The classification
of so-called borderline products is sometimes difficult. An updated EU guideline may be able to help.
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Do liquid, sterile medicinal products have to be particle-free?
According to the
pharmacopoeias, parenteralia, i.e. sterile medicinal products for injection
purposes, must be 100% visually inspected. In addition to damages to the
primary container, the absence of particles has also to be checked. But do
these medicinal products also have to be 100% free of particles? Read more here.
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As of 1 January 2020 the eCTD is mandatory for ALL CEP applications including notifications, revision, renewal and new applications
According to the EDQM
roadmap for electronic submissions for CEP applications, a major change will be
implemented as of 1 January 2020: • eCTD will become mandatory for all CEP
applications. • EDQM will stop accepting NeeS submissions for notifications, revisions
and renewal applications. Therefore, all such submissions need to be in eCTD
format.
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EU and US reach a milestone in mutual recognition of inspections of medicines manufacturers
Read more
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News from the clinical trial portal and database
The new CTR becomes applicable six
months after the notice of the full functionality of the CTIS. The EMA informed
that the CTIS now enters a phase of agile, iterative delivery, to prepare the
system for audit.
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Advice on impacts of using antimicrobials in animals
The European Medicines
Agency (EMA) is involved in monitoring and evaluating the risks of using
antibiotics in animals. It has looked in particular at the risk of the
development of antimicrobial resistance in animals and of the possible
transmission of resistance to humans.
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Pharmeuropa Volume 31 No 3, July 2019
Users of CEPs are invited
to provide comments on draft monographs published in Pharmeuropa 31.3 before 30
September 2019.
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Creams, Gels & Pastes redefined
A revised version of the
Ph. Eur. Monograph Semi-solid preparations for cutaneous application has been
published in Pharmeuropa.
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Medicine shortages: EU network takes steps to improve reporting and communication
Read more
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FDA warns repackers distributing pharmaceutical ingredients, including opioids, for putting consumers at risk
The U.S. Food and Drug Administration
has issued warning letters to three repackers of active pharmaceutical
ingredients (API), B&B Pharmaceuticals, Inc., Asclemed USA, Inc., doing
business as Enovachem and Spectrum Laboratory Products, Inc., for significant
violations of current good manufacturing practice (CGMP) requirements.
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10th Edition of the Ph. Eur.
The 10th edition of the Ph. Eur. will be released in July 2019. The new and revised texts will become official on 1 January 2020.
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QRD product-information annotated template (English) version 10.1 - highlighted
Read more
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Serialisation: New Guidance for EU Inspectors
The European Commission has published an Aide-Memoire to help both manufacturers and inspectors to verify compliance with the safety features regulation.
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Temporary interim limits for NMBA, DIPNA and EIPNA impurities in sartan blood pressure medicines
Read more
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More Notified Bodies Give Up on EU MDR/IVD Certification
“Following recent market developments,
we have made the strategic business decision to exit from [notified body
certification] services,” said Lloyd’s Register Quality Assurance.
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ECHA to scrutinise all REACH registrations by 2027
ECHA will start to
evaluate 20 % of registration dossiers in each tonnage band to improve the
compliance of REACH registrations. This will mean approximately 30 % of all
registered chemicals will be checked.
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The Human Medicines (Amendment etc.) (EU Exit) (No. 2) and the Medical Devices (Amendment etc.) (EU Exit) (No. 2) Regulations 2019
These Regulations (which
come into force immediately before exit day) are made to correct drafting
defects and omissions in the Human Medicines (Amendment etc.) (EU Exit)
Regulations 2019 (S.I. 2019/775) and the Medical Devices (Amendment etc.) (EU
Exit) Regulations 2019 (S.I. 2019/791). This is to ensure that the published
policy in relation to the regulation of human medicines and medical devices in
a no deal EU exit scenario is properly reflected in those instruments. Those
instruments, which come into force on exit day, amend the Human Medicines
Regulations 2012 (S.I. 2012/1916 – “HMRs”), associated Medicines (Fees) Regulations
2016 and the Medical Devices Regulations 2002 (S.I. 2002/618 – “MDRs”) to
ensure they are fit for purpose in a no deal EU exit.
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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
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United Kingdom's withdrawal from the European Union ('Brexit')
On 29 March 2017, the United Kingdom
(UK) notified the European Council of its intention to withdraw from the
European Union (EU), a process known as 'Brexit'. The European Medicines Agency
(EMA) is making preparations to ensure that it can continue to deliver on its
mission and protect public and animal health after the UK leaves the EU.
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Leuprorelin-containing depot medicinal products
Leuprorelin , See
"List of the medicines affected by the referral (Annex I)", Article
31 referrals, Procedure started
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Control of nitrosamine impurities in sartans: revision of five Ph. Eur. monographs
The European Commission
has issued its final legally binding decision on medicines containing
valsartan, candesartan, irbesartan, losartan and olmesartan on 2 April 2019.
This decision was based on the scientific assessment of angiotensin-II-receptor
antagonists (sartans) containing a tetrazole group performed by the Committee
for Medicinal Products for Human Use (CHMP), the conclusions of which are set
out in Annex I to the European Commission Decision C(2019) 2698 final.
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Two additional countries to benefit from EU-US mutual recognition agreement for inspections
Read more
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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
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EMA closed 10 June 2019
EMA is closed from 18:30 on Friday 7 June until 7:30 on Tuesday 11 June 2019.
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Alegações em produtos cosméticos
Conforme referido na Circular Informativa n.º
106/CD/100.20.100/2018, de 27/07/2018, o Regulamento (CE) n.º 1223/2009, de 30
de novembro, relativo aos produtos cosméticos, estabelece que os consumidores
devem ser protegidos contra alegações enganosas e garante que a informação
transmitida através dessas alegações é útil, compreensível e fiável, permitindo
aos consumidores tomar decisões informadas e escolher os produtos que melhor se
adequem às suas necessidades e expectativas.
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cGMP Cleaning Validation - FDA's Current Requirements
What do authorities require
regarding cleaning validation? Official GMP inspection reports deliver helpful
answers to this question. Through the Freedom of Information Act, the FDA is
required to publish inspection results. This is particularly the case with
Warning Letters. Here, even details of deficiencies regarding cleaning
validation are included in the Warning Letter.
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Consultation on draft guideline on quality requirements for medical devices in combination products
Read more
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ICH E19 public consultation
A new ICH-E19 draft guideline on the
optimisation of safety data collection in interventional clinical trials and
non-interventional studies has been published by ICH for public consultation.
The guideline objective is to provide internationally harmonised guidance on
when it would be appropriate to use a selective approach to safety data
collection in some late-stage pre-marketing or post-marketing studies, and how
such approach would be implemented. Comments should be submitted by 29
September 2019 to the following email address: ich@ema.europa.eu.
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OMS quer mais transparência no preço dos medicamentos
Os Estados-membros da Organização Mundial da Saúde (OMS)
aprovaram uma resolução que desafia os países a partilharem informações sobre
os preços negociados com a indústria farmacêutica, sugerindo também uma maior
transparência em torno das patentes de medicamentos e resultados de ensaios
clínicos. O documento foi aprovado durante a 72.ª Assembleia Mundial da Saúde,
realizada em Genebra, entre 20 e 28 de maio.
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Revised USP chapter <3> Topical and Transdermal Product Quality Tests
The revised USP general chapter
<3> TOPICAL AND TRANSDERMAL DRUG PRODUCTS - PRODUCT QUALITY TESTS has
been approved.
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Lawmakers Claim Purdue Influenced WHO Opioid Guidelines
A bi-partisan congressional
report claims that Purdue Pharma helped shape World Health Organization
recommendations for prescribing opioids.
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ERS esclarece tratamento de dados em saúde
A Entidade Reguladora da Saúde (ERS) emitiu um parecer sobre o tratamento de dados em saúde, tendo por base o novo Regulamento Geral de Proteção de Dados (RGPD), que exige aos prestadores de cuidados de saúde, independentemente da sua natureza jurídica ou dimensão, uma adequação exigente e cuidada dos seus processos de tratamento de dados pessoais, sempre visando a garantia dos direitos e liberdades dos titulares desses dados.
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New WHO Draft for GDP Guidance
The World Health Organisation WHO plans to revise its Good Storage and Distribution Practice guidelines and to consolidate the rules in one single document.
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Pau de Cabinda - Esclarecimento adicional
A DGAV disponibiliza esclarecimento adicional sobre a
“Proibição do uso de Pau de Cabinda a partir de 14 Maio 2019”.
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Recent GMP defects in process validation
What are the authorities' requirements regarding process validation? Regulatory GMP inspection reports are useful in answering that question. The "Freedom of Information Act" obliges the US FDA to publish all inspection results. The FDA does that particularly when it comes to warning letters.
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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 May 2019
Read more
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FDA Lays Out Weight of Evidence Guidelines for Fetal Toxicity in Oncology
The weight of evidence
could include a review of existing literature.
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New office-based GDP-Inspection Process in UK
The U.K. Medicines and Health Products Agency (MHRA) is testing a new, office-based inspection process - without a visit of the site.
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How does the GDPR impact Clinical Trials?
The European Commission released a Question and Answers paper on the interplay between the Clinical Trials Regulation (CTR) and the General Data Protection Regulation (GDPR).
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Implementação das obrigações legais no que respeita aos dispositivos de segurança
Read more
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Medical devices
In early June 2019 EMA will
publish a draft guideline on quality requirements for regulatory submissions
for medicines that include a medical device (drug-device combinations). The
guidance will cover devices which are integral, co-packaged or supplied
separately. The public consultation is expected to last three
months.
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The ICH E8(R1) reaches Step 2b of the ICH Process
The ICH E8(R1) draft Guideline on General Considérations for Clinical Trials reached Step 2b of the ICH Process in May 2019 and has entered the public consultation period.
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Statement from Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., and Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research
It can be a challenge for
health care professionals and patients to find quality scientific information
about the safety of drugs and biological products when used during pregnancy or
breastfeeding. Ethical challenges often arise in studying women in these
populations as there are valid concerns about maternal and fetal safety.
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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
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MedTech Europe Says EU MDR/IVDR Transition is Not Workable
MedTech Europe is warning
European regulators that the EU’s new regulatory system for devices won’t be
ready on time and said the delay will jeopardize patient lives.
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Corrigendum to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices
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Two additional countries to benefit from EU-US mutual recognition agreement for inspections
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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?
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European Parliament Evens Scales for Generics Makers With New SPC Waivers
The European Commission
says the reform will “remove a major competitive disadvantage.”
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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.
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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
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IndisponibilidadePor motivos de ordem técnica, o site do Infarmed estará indisponível durante o dia 23 de abril (amanhã, 3ª feira). Read more
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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).
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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.
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Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure
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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 April 2019
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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New EudraVigilance system improves reporting of side effects and detection of safety signals
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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.
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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.
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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.
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GMP for Cannabis - What is required?
More and more countries allow cannabis for medicinal purposes - But what are the regulatory requirements?
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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?
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Medicamentos veterinários: Atualização Brexit
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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.
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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").
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Sterilisation of the medicinal product, active substance, excipient and primary container
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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Information – Withdrawal of the United Kingdom and EU rules on batch testing of medicinal products
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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.
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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.
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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.
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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.
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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.
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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.
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Safety Features: Handling of Alerts
The safety feature provisions enetered into force - How to report a falsified pack?
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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.
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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).
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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.
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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.
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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.
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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
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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.
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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.
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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.
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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).
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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.
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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.
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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.
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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.
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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.
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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.
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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
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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.
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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.
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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?
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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).
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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.
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FDA Revises Guidance on CGMPs for Outsourcing Facilities
The agency said it continues to find “concerning conditions and practices” in outsourcing facilities.
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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.
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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.
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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.
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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.
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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.
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Mobile scanning and other technologies in the labelling and package leaflet of centrally authorised medicinal products
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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.
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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.
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Launch of the new EudraVigilance system: questions and answers from stakeholders
Update Read more
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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.
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Guidance on the format of the risk management plan (RMP) in the EU - in integrated format (Rev. 2.0.1)
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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.
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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.
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Questions and answers (version 12) - Safety features for medicinal products for human use
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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.
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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
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Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’
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Disabling and potentially permanent side effects lead to suspension or restrictions of quinolone and fluoroquinolone antibiotics
Read more
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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.
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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
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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.
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Circular nº 1/2018: Instrucción sobre excipientes
Actualización de la información sobre excipientes en la información de medicamentos.
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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.”
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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).
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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).
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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.
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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.
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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.
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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.
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Training presentations on Active Substance Master File (ASMF) work sharing procedure
New Read more
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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.
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Questions and answers related to the United Kingdom's withdrawal from the European Union with regard to the biocides sector
Update Version Read more
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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.
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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.
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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.
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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
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EU authorities take further action in ongoing review of sartans: Zheijiang Huahai placed under increased supervision.
Read more
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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.
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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.
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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.
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Ph. Eur. Supplement 9.7: CEP holders are invited to update their applications
Supplement 9.7 of the Ph. Eur is now available.
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FDA: Guidance on Quality Chewables
In vitro disintegration tests should be conducted using established disintegration equipment and methods, the FDA says.
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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).
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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.
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Perguntas e respostas sobre o sistema dos dispositivos de segurança
O sistema dos dispositivos de segurança surgiu com a diretiva 2011/62/EU do Parlamento Europeu e do Conselho, de 8 de junho de 2011 e encontra-se regulado pelo Regulamento Delegado (UE) 2016/161, da Comissão de 2 de outubro de 2015, de aplicação direta na ordem jurídica nacional, e pelo Estatuto do medicamento, na sua redação atual.
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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.
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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.
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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).
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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.
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Portugal to also benefit from EU-US mutual recognition agreement for inspections
Read more
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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".
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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.
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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.
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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.
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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.
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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.
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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
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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.
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Sanofi’s Treatment for Blood-Clotting Disorder Approved in Europe
The authorization marks Sanofi’s first approval for a nanobody-based medicine
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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.
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Pre-notification check for type IA variations: ensuring the quality of veterinary type IA variation submissions
Update Read more
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What information is included in a CEP?
The "Certificate of suitability to the Monographs of the European Pharmacopoeia" (CEP) contains information on an active pharmaceutical substance with regard to the European Pharmacopoeia. It is an important document of the authorisation application. Read more about what information is relevant for a CEP and what do CEP holders and authorisation applicants have to consider.
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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.
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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.
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Keeping medicines safe Keeping medicines safe
How EMA monitors medicines once they are on the market
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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.
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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.
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Launch of the new EudraVigilance system: questions and answers from stakeholders
Update Read more
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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.
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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".
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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.
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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.
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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.
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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".
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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.
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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.
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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.
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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.
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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.
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IT systems unavailable from 27 to 30 July 2018
EMA website and online applications will be temporarily unavailable
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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.
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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.
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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.
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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.
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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.
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EMA’s proactive publication of clinical data a success
First report on unprecedented transparency policy shows high user satisfaction.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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
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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.
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Procedure for orphan-medicinal-product designation: Guidance for sponsors submitting an application via the current existing submission process until 19 Sept 2018
Read more
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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.
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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.
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Quality defects: EMA updates Defective Product Report Template
The European Medicines Agency (EMA) has updated their document for reporting quality defects in drug products.
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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.
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Time Is Running Out to Prepare for New EU MDR/IVDR: MedTech Europe
One year after the EU finalized its new medical device and in vitro diagnostics regulations there has been little progress in helping industry transition to the new regulations, according to MedTech Europe.
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New PIC/S guidance on GMP inspection reliance based on draft by ICMRA with aim to maximise inspection resources for GMP compliance of overseas facilities
PIC/S has adopted a new guidance on GMP inspection reliance (PI 048-1), which entered into force on 1 June 2018.
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Falsified Medicines Directive - securPharm status report for 2018
There isn't much time left until the safety features required in the future will have to be implemented in order to comply with the Falsified Medicines Directive which will enter into force on 9 February, 2019. The German initiative securPharm has published a status report in this issue for the year 2018.
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Investigational Medicinal Products (IMP): Applicability of the GDP-Guidelines
A new draft EMA
Guideline requires that GDP-Guidelines for medicinal products should be taken
into consideration for IMP shipments.
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Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use
June 2018
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Monograph for Water, highly purified (1927) to be suppressed from the European Pharmacopoeia
Following a decision taken by the European Pharmacopoeia (Ph. Eur.) Commission at its 160th session (March 2018), the monograph for Water, highly purified (HPW) will be suppressed on 1 April 2019 from the Ph. Eur. The monograph suppression is a consequence of the recent revision of the monograph for Water for injections (0169), which now allows for purification processes equivalent to distillation for producing water for injections (WFI), in addition to distillation. Hence, the HPW monograph is a duplication of the WFI monograph in terms of quality requirements and production methods, and as such became redundant.
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ICH Q3D(R1) revision reaches Step 2b of the ICH Process
The ICH Q3D(R1) Revision of the ICH Q3D Guideline for Elemental Impurities reached Step 2b of the ICH Process in May 2018 and now enters the consultation period.
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List of safety concerns per approved Risk Management Plan (RMP) of active substances per product
Update Read more
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Unexpected deviation: what is the Role of the QP?
The European Medicines Agency (EMA) has updated its Questions and Answers Section with an amendment to further clarify the role of the QP in the context of handling unexpected deviations.
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List of centrally authorised products requiring a notification of a change for update of annexes
Update. Read more
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Development of antibiotics for children - towards a global approach
The European Medicines Agency (EMA), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and the United States' Food and Drug Administration (FDA) are co-organising a workshop to discuss the development of antibiotics for children.
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Towards harmonisation in the classification of medicines across Europe
The Committee of Ministers of the Council of Europe adopted a revised Resolution on the classification of medicines as regards their supply. It calls on the States Parties to the Convention on the Elaboration of a European Pharmacopoeia (Ph. Eur. Convention) to regularly provide information on their national classifications of medicines for inclusion in the Melclass database and follow the recommendations to classify active substances on the basis of the supply conditions of the medicines that contain them, as listed in the database. The new Resolution CM/Res(2018)1, which supersedes the previous Resolution ResAP(2007)1 from 2007, will continue to play a key role in providing 800 million citizens across Europe with safe access to medicines and to support national authorities in ensuring the appropriate and responsible use of medicines.
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New EDQM guideline "How to read a CEP"
EDQM has elaborated the guideline “How to read a CEP” with the aim of describing in detail the information conveyed on the Certificates of suitability to the Monographs of the European Pharmacopoeia (CEP). This document is intended to give Industry and Competent Authorities clarification on the meaning of the statements laid down on the CEPs.
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FDA Issues Final Guidance on GMPs for APIs
The FDA released final guidance on its Q7 guidelines on good manufacturing practices for active pharmaceutical ingredients, using a question and answer format to clarify the document developed through the International Conference on Harmonization.
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Targeted stakeholder consultation on duplicate marketing authorisations for biological medicinal products
Read more
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FDA approves novel preventive treatment for migraine
The U.S. Food and Drug Administration approved Aimovig (erenumab-aooe) for the preventive treatment of migraine in adults. The treatment is given by once-monthly self-injections. Aimovig is the first FDA-approved preventive migraine treatment in a new class of drugs that work by blocking the activity of calcitonin gene-related peptide, a molecule that is involved in migraine attacks.
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FDA approves the first non-opioid treatment for management of opioid withdrawal symptoms in adults
The U.S. FDA approved Lucemyra (lofexidine hydrochloride) for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults. While Lucemyra may lessen the severity of withdrawal symptoms, it may not completely prevent them and is only approved for treatment for up to 14 days. Lucemyra is not a treatment for opioid use disorder (OUD), but can be used as part of a broader, long-term treatment plan for managing OUD.
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EU Data Protection Regulation - Impact on Clinical Trials & Pharmacovigilance
The EU Data Protection Regulation will apply from May 25, 2018. It will introduce new data protection requirements in the EU as well as substantial fines for breaches of the data protection rules.
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Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use
May 2018 Read more
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FDA expands approval of Gilenya to treat multiple sclerosis in pediatric patients
The U.S. Food and Drug Administration approved Gilenya (fingolimod) to treat relapsing multiple sclerosis (MS) in children and adolescents age 10 years and older. This is the first FDA approval of a drug to treat MS in pediatric patients.
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FDA Clarifies the Term ‘Outsourcing Facility’ and Requirements for 503A Compounders
As part of its increased focus on drug compounding, the FDA issued a final guidance clarifying the term “outsourcing facility” and detailing requirements for compounders operating under 503A that are next to an outsourcing facility.
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Roche Gains Priority Review for Tecentriq Combo Treatment in Cancer Patients
The FDA granted priority review for Roche’s Tecentriq (atezolizumab) used in combination with Avastin (bevacizumab), paclitaxel and chemotherapy for the first-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC) patients.
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Questions and answers: Good manufacturing practice
This page lists the European Medicines Agency's answers to frequently asked questions, as discussed and agreed by the Good Manufacturing Practice (GMP) / Good Distribution Practice (GDP) Inspectors Working Group. The section on “EU GMP guide annexes: Supplementary requirements: Annex 16” was updated.
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Two years of PRIME
In the two years since its launch, the PRIority Medicines scheme (PRIME) of the European Medicines Agency (EMA) has succeeded in driving innovation and improved the efficiency of the development process in therapeutic areas with the most pressing unmet medical needs. The goal is to support and optimise medicine development, so that patients whose diseases cannot be treated or who need better treatment options have access to new medicines that enable them to live healthier lives.
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Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP
Read more
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Evaluation of EMA fee system for the approval and monitoring of medicines:
Public consultation launched today.
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EMA 2017 annual report published
The 2017 annual report published today provides an overview of the work of the European Medicines Agency (EMA) and highlights last year’s major achievements in protecting and promoting public and animal health in the European Union (EU).
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Quality Risk Management: What Inspectors are looking for
ICH Q9 is the major guideline providing principles and examples of tools for Quality Risk Management (QRM). But how do competent authorities look at these QRM systems in their GMP inspections?
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Q & A: Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities - updated 27/04/2018
Questions and answers on implementation of risk-based prevention of
cross-contamination in production and ‘Guideline on setting health-based
exposure limits for use in risk identification in the manufacture of different
medicinal products in shared facilities’.
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Updated rules for clinical development of vaccines
EMA launches public
consultation on revised guideline on clinical evaluation of vaccines.
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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
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Decree-Law no. 26/2018 – National Official Journal no. 80/2018, Series I of 2018-04-24
Changes the legal status of the medicinal products for human use, transposing Directive (EU) 2017/1572.
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Public hearing about medicinal products containing quinolones and fluoroquinolones
It is ongoing the safety review of the medicinal products containing quinolones and fluoroquinolones due to the occurrence of cases of severe and persistent adverse reactions which mostly affect the muscles, joints and the nervous system.
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FDA Issues Final Guidance on API Good Manufacturing Practices Guidelines
The FDA released final guidance on its Q7 guidelines on good manufacturing practices for APIs, using a question and answer format to clarify the document developed through the International Conference on Harmonization.
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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
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Auditing Starting Materials - new APIC Guideline defines Standards
The use of starting materials in the production process for active pharmaceutical ingredients marks the starting point for GMP. But how can the quality of starting materials be ensured?
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Resolution no. 481/2018 – National Official Journal no. 75/2018, Series II of 2018-04-17
Change of the list of Previous Notification of transactions of medicinal products to outside the country.
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Meeting highlights from the PRAC: 9-12 April 2018
The Pharmacovigilance Risk Assessment Committee (PRAC) has started a review of the risk of dosing errors with methotrexate medicines, used to treat cancers such as acute lymphoblastic leukaemia and various inflammatory conditions including rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis and psoriatic arthritis.
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Increasing oversight of API manufacturing through international collaboration
The European Medicines Agency (EMA) and its European and international partners have successfully strengthened their interactions to improve the oversight of active pharmaceutical ingredient (API) manufacturers worldwide, as highlighted in the International API inspection programme report for 2011-2016, published today. APIs are the substances responsible for the activity of a medicine.
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Redistribution of UK’s portfolio of centrally authorised products
The EU27 Member States and the European Medicines Agency (EMA) have completed the reallocation of the medicines for which the United Kingdom’s (UK) Medicines and Healthcare products Regulatory Agency (MHRA) and Veterinary Medicines Directorate (VMD) are currently rapporteur or co-rapporteur appointed by the scientific committees to coordinate the evaluation of a medicine.
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Transitional period applicable to the new Regulations of Medical Devices and In Vitro Diagnosis Medical Devices
In the context of the group of Competent Authorities for Medical Devices and In Vitro Diagnosis Medical Devices in what concerns inspection of the market and clinical investigation (CAMD), a Task Force was established (CAMD Transition Sub Group), with the purpose of discussing the content, harmonize the interpretation and clarify the rules related to the transitional period applicable to the new Regulations of Medical Devices and In Vitro Diagnosis Medical Devices.
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Revised: guideline “Validation of Computerised Systems”
Since the adoption of the first version of the “Validation of Computerised Systems” guideline in May 2009, most of the Network members have introduced computerised systems e.g. Laboratory Information Management Systems (LIMS) and electronic document management systems into their labs which have become commonly used working tools of the Network. For that reason and also based on experiences gained during Mutual Joint Audits, the guideline has been profoundly restructured and revised.
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Draft addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections to address paediatric-specific clinical data requirements - First version
Draft: consultation open
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How to prepare for an inspection?
GDP inspections by supervisory authorities have grown in number and intensity. Many partners in the distribution chain also have customer audits to face. What does the ideal preparation for a GDP inspection look like?
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MHRA GxP Data Integrity Definitions and Guidance for Industry
MHRA has produced draft GxP data integrity guidance for industry and we welcome your comments.
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Public consultation concerning the EU template for GMP non-compliance statement
Deadline for comments: 15/05/2018
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Rapid implementation of the monograph Products of fermentation (1468).
Due to the public health risk associated with histamine contamination, further requirements related to the quality of raw materials have been added to the Raw materials section of the monograph on Products of fermentation (1468). The implementation date for the revised monograph was 1 April 2018.
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FDA expands approval of Blincyto for treatment of a type of leukemia in patients who have a certain risk factor for relapse
The U.S. Food and Drug Administration granted accelerated approval to Blincyto (blinatumomab) to treat adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission but still have minimal residual disease (MRD). MRD refers to the presence of cancer cells below a level that can be seen under the microscope. In patients who have achieved remission after initial treatment for this type of ALL, the presence of MRD means they have an increased risk of relapse.
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Technical expert seminar on pharmaceuticals related matters, following UK withdrawal (8 March 2018)
The
European Commission DG SANTE convened a technical expert seminar on
pharmaceuticals related matters in order to discuss matters related to
preparedness of the UK withdrawal.
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Retinoids – new recommendations on the risks of teratogenicity and neuropsychiatric disorders
The European Medicines Agency (EMA) has completed its review of retinoid medicines, and confirmed that an update of measures for pregnancy prevention is needed. In addition, a warning on the possibility that neuropsychiatric disorders (such as depression, anxiety and mood changes) may occur should be included in the prescribing information for oral retinoids.
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EU recommendations for 2018/2019 seasonal flu vaccine composition
The European Medicines Agency (EMA) has issued the European Union (EU) recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from autumn 2018.
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 March 2018
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended six medicines for approval, including one orphan medicine, at its March 2018 meeting.
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ECA Data Integrity Task Force issues Version 2.0 of Data Integrity Guide
With the authorities' increasing attention to data governance and data integrity the ECA's Data Integrity Task Force's just released version 2.0 of its Data Integrity Guide provides an ideal tool for implementing data integrity in practice.
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Clinical Trial Regulation
The way clinical trials are conducted in the European Union (EU) will undergo a major change when the Clinical Trial Regulation comes into application in 2019. The Regulation harmonises the assessment and supervision processes for clinical trials throughout the EU, via an EU portal and database. The European Medicines Agency (EMA) will set up and maintain the portal and database, in collaboration with the Member States and the European Commission.
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Common issues identified during clinical trial applications
This guidance identifies common issues with validation and assessment of clinical trial applications and how to avoid them.
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Additional Data requested for New Applications in the Mutual Recognition and Decentralised Procedures
Read more
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FDA Adopts Final ICH M7(R1) Mutagenic Carcinogen Guideline
Potential or actual impurities in drugs should be studied for their mutagenic properties, according to a revision to an ICH guideline addendum on mutagenic carcinogens, now adopted by the FDA.
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European Pharmacopoeia Reference Standards recently released
9 new Ph. Eur. Reference Standards (RS) were released in February 2018.
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FDA Releases Finalized Q&A Guidance on Choosing Chemical Drug Starting Materials
The FDA finalized a Q&A guidance clarifying the International Council for Harmonization’s November 2012 Q11 guidance on development and manufacture of drug substances — giving recommendations for information that should be provided in authorization applications for starting materials.
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CMDh procedural advice on changing the RMS - Track version
In exceptional circumstances, a Marketing Authorisation Holder (MAH) may request a change of the Reference Member State (RMS). The change may be needed when a MAH or a subsidiary responsible for the communication on behalf of the MAH has been closed in the RMS, or when a medicinal product has more than one RMS for the different pharmaceutical forms of the medicinal product, or, subject to clear justification, due to the sunset clause in the RMS. These are examples and other reasons might be justified.
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Four more EU Member States benefit from EU-US mutual recognition agreement for inspections
The mutual recognition agreement between the European Union (EU) and the United States (US) to recognise inspections of manufacturing sites for human medicines conducted in their respective territories is progressing as planned. The US Food and Drug Administration (FDA) confirmed the capability of four more EU Member States (Czech Republic, Greece, Hungary, and Romania) to carry out good manufacturing practice (GMP) inspections at a level equivalent to the US. There are now a total of 12 Member States whose inspection results the FDA can rely on to replace their own inspections.
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Revision of EU GMP Chapter 1 to enhance Quality Risk Management
The European Medicines Agency (EMA) is planning to revise Chapter 1 of the EU-GMP Guidelines. In the new document, risk-based approaches will be included to prevent drug shortages.
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FDA to Require GCP Compliance for Device Trials That Rely on Foreign Clinical Data
Next year, the FDA will begin to require that data from medical device studies conducted outside the U.S. be gathered in accordance with good clinical practices, including review and approval from an independent ethics committee and well-documented informed consent.
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 February 2018
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended five medicines for approval, including two orphan medicines, at its February 2018 meeting.
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New standards for haemophilia patients care in Council of Europe Resolution
The Council of Europe’s decision-making body, the Committee of Ministers, adopted Resolution CM/Res(2017)43 on principles concerning haemophilia therapies at the end of 2017. Elaborated by the European Committee on Blood Transfusion (CD-P-TS) on the basis of the recommendations from the Wildbad Kreuth Initiative IV meeting « Optimal use of clotting factors and platelets » of 2016*, the new Resolution replaces Resolution CM/Res (2015)3 on the same subject and calls on governments to take into account specific principles for the treatment of haemophilia and care for haemophilia patients.
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Medical devices: UK notified bodies
UK notified bodies listed under medical device directives.
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EMA's GMP Plans for 2018
The European Medicines Agency has published the 2018 Work Plan. The EMA plans some new guidance and some revisions to existing requirements.
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Highlights from the twelfth industry stakeholder platform on the operation of pharmacovigilance in the European Union
Read more
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New versatile reference standard for equipment qualification
The EDQM announces the availability of a new reference standard: Sodium aminosalicylate dihydrate for equipment qualification CRS 1 replacing the former Amoxicillin trihydrate for performance verification CRS, which will be discontinued as of 1 April 2018.
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Health-EU Newsletter - Assessing health technology in the EU: Commission proposes to reinforce cooperation amongst Member States
Read more
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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?
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FDA Publishes Guidance on Microbiology Data for Antibacterial Drugs
Sponsors of systemic antibacterial drugs should evaluate their products against test panels of relevant bacteria and against approved drugs with similar mechanisms of activity, the FDA said, in a newly revised guidance.
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How is the Data Governance System to be implemented in your Company?
The PIC/S draft guideline "Good Practices for Data Management and Integrity" requires every company to have a data governance system in place in addition to their existing QM system. But how can such a system be implemented?
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Question & Answers on Chapter 1 QUALITY MANAGEMENT of the EU Good Distribution Practice Guideline
The European GDP Guideline which has been published in a revised version on 7 March 2013 has caused a lot of discussion since then. Many requirements leave room for interpretation. On the GDP Association Webpage a section has been set up with frequently asked questions (FAQs).
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UK and China sign Memorandum of Understanding on Medicine and Device Regulation
The agreement pledges new areas of cooperation such as an exchange of learning from the accelerated access review (AAR) and how to effectively regulate the trading of medicines online.
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Evaluation of advanced therapy medicines
The European Medicines Agency (EMA) has updated its procedural advice on the evaluation of advanced therapy medicinal products (ATMPs). The update aims to streamline some procedural aspects, strengthen collaboration between EMA’s scientific committees and address specific needs of ATMP developers in the evaluation procedure for initial marketing authorisations, to help developers of these medicines – often small and medium-sized enterprises (SMEs) or academic spin-offs – navigate the regulatory process in the EU.
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Regulatory requirements for Audit Trail Reviews
Audit Trails and their reviews are an important requirement in the current GMP policies. Specific requirements can be found in a number of guidelines, these days. Despite that, many questions about the specific implementation of this complex topic into practice remain.
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The EDQM "Guidance for electronic submissions for CEPs applications" has been revised and application forms have been updated accordingly
The EDQM has revised the document «Guidance for electronic submissions for Certificates of Suitability (CEPs) applications».
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 January 2018
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended seven medicines for approval, including one orphan medicine, at its January 2018 meeting.
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Ordinance no. 36/2018 – National Official Journal no. 19/2018, Series I of 2018-01-26
Determines that the measures of treatment of patients with ichthyosis benefit from an exceptional reimbursement regimen.
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FDA Clarifies Conditions for Mixing, Diluting or Repackaging Biologics
The FDA issued a final guidance on approved biologics that are mixed, diluted or repackaged, noting when the agency will not take action against violations of its standard rules on product misbranding and false and misleading labeling.
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EFSA confirms health concerns for hydroxyanthracene derivatives in food
Some substances belonging to a group of plant ingredients known as hydroxyanthracene derivatives can damage DNA and may cause cancer, said EFSA after assessing their safety when added to food.
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236 substances shortlisted for possible regulatory action
ECHA has selected 236 substances for further scrutiny by the Member State competent authorities in its annual screening exercise. The competent authorities will carry out a manual examination of dossiers they prioritise to decide whether regulatory action is needed.
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Pharmeuropa Volume 30 No 1, January 2018
Users of CEPs are invited to provide comments on draft monographs published in Pharmeuropa 30.1 before 31st March 2018.
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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
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New Annex 1: Consequences for the QP
The new draft of Annex 1 (Manufacture of Sterile Medicinal Products) will be much more extensive and contain some new rules and additions. There are also some things in the Annex 1 draft QPs need to consider.
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MHRA update to pharmaceutical companies on exit preparations
An update from the Medicines and Healthcare products Regulatory Agency (MHRA) to pharmaceutical companies on preparations for exiting the European Union.
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Chair of EMA’s committee for orphan medicines receives award for outstanding patient engagement
Bruno Sepodes, Chair of the European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP), has received the EURORDIS European Rare Disease Leadership Award as recognition of his commitment to involve patient advocates in all discussions and decisions related to orphan medicines.
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PRAC recommends suspending hydroxyethyl-starch solutions for infusion from the market
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended the suspension of the marketing authorisations for hydroxyethyl-starch (HES) solutions for infusion across the European Union. These products are used as plasma volume replacement following acute (sudden) blood loss, where treatment with alternative products known as ‘crystalloids’ alone is not considered to be sufficient.
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FDA acts to protect kids from serious risks of opioid ingredients contained in some prescription cough and cold products by revising labeling to limit pediatric use
The U.S. Food and Drug Administration announced that it is requiring safety labeling changes to limit the use of prescription opioid cough and cold medicines containing codeine or hydrocodone in children younger than 18 years old because the serious risks of these medicines outweigh their potential benefits in this population. After safety labeling changes are made, these products will no longer be indicated for use to treat cough in any pediatric population and will be labeled for use only in adults aged 18 years and older. Labeling for the medications also is being updated with additional safety information for adult use – including an expanded Boxed Warning, the FDA’s most prominent warning ‒ notifying about the risks of misuse, abuse, addiction, overdose and death, and slowed or difficult breathing that can result from exposure to codeine or hydrocodone.
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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
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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
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MSs Recommendations on Extension Applications in Mutual Recognition and Decentralised Procedures
Read more
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PRAC recommendations on signals adopted at the PRAC meeting of 27-30 November 2017
Read more
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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
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Pharmeuropa: Texts for comments
Pharmeuropa issue 30.1 is now complete. Submit your comments until 31 March 2018. Read more
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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
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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.
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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.
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Extension of pilot for splitting of MRP/DCPs
Update on the "Extension of pilot for splitting of
MRP/DCPs".
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Annual Price Revision for the Generic Medicinal Products 2018
Binding Information Newsletter no. 171, from 22-12-2017.
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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:
Read more
https://dre.pt/web/guest/home/-/dre/114394848/details/maximized?serie=I&day=2017-12-22&date=2017-12-01
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Targeted stakeholders consultation on the revision of annex 1, on manufacturing of sterile medicinal products, of the Eudralex volume 4
Read more
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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.
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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
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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
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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
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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
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GVP Update 2017
There have been recent developments within EudraLex Volume 9 - Guidelines on good pharmacovigilance practices (GVP). Read more
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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
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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
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FDA's new Guidances on the Approval of Generic Drugs
The FDA has recently published various guidelines on application procedures for generics. Read more
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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
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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
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Guideline on good pharmacovigilance practices (GVP): Module VII – Periodic safety update report - Explanatory note
Adopted Read more
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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Summaries of scientific recommendations on classification of advanced therapy medicinal products
The European Medicines Agency´s Committee for Advanced Therapies delivers scientific recommendations on whether a medicine can be classified as an advanced therapy medicinal product (ATMP). The Agency publishes the outcomes of these assessements in the format of summary reports.
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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
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PRAC recommendations on signals adopted at the 25-29 September 2017 PRAC meeting
Adopted Read more
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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
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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
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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
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New EU GMP Guideline for IMPs
The EU Commission published two new GMP documents in the Official Journal of the European Union. Read more
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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
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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
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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
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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
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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
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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
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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
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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
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Medical devices: software applications (apps)
Information on when software applications are considered to be a medical device and how they are regulated. Read more
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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
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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
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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
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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
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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
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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.
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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
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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
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European Medicines Agency guidance for applicants seeking scientific advice and protocol assistance
Updated guidance. Read more
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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
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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
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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
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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
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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
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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
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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.
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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
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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
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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
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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
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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
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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
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Revised Ph. Eur. Chapter Tablets
Recently, the revised PH. Eur. Monograph Tablets (0478) has been published in Ph. Eur. Supplement 9.3. Read more
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Strengthening EU-US cooperation in medicine inspections
The European Commission (EC), the United States (US) Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have signed a new confidentiality commitment that allows the Us regulator to share non-public and commercially confidential information, including trade secret information relating to medicine inspections with EU regulators. This confidentiality commitment is a milestone in the ongoing implementation of the mutual recognition of inspections of medicine manufacturers and it aims to strengthen the EU-US relationship. Ultimately it will contribute to a more efficient use of inspection resources by regulators for the protection of human and animal health. Read more
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News questions and answers about safety features - Version 7 of the EU Q&As published
The soon-to-be mandatory safety features for the implementation of the Falsified Medicines Directive have to be implemented by February 9th, 2019. The European Commission has published Version 7 of the questions and answers about safety features in June 2017. Read more
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FDA’s Expedited Programs Predict Better Drugs, But Companies Are Still Slow to Confirm Benefits, Researchers Say
The FDA has largely succeeded in expediting the review of drugs with larger health gains, but postmarket trials by companies have fallen behind in confirming some of those benefits, with many not using the gold standard of randomized controlled trials, according to two independent studies. Read more
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Monthly report on application procedures guidelines and related documents for veterinary medicines: July 2017
This report, which is updated every month, provides current information related to the volume and evaluation of pre and post-authorisation applications for medicinal products for veterinary use received by the European Medicines Agency. Read more
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What's new in pharmacovigilance - QPPV Update - Issue 2 - 2017
Information on recent developments in EU Pharmacovigilance, relating to medicines for human use, and includes updates on the EU network activities and relevant projects. Read more
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Annual report of the Pharmacovigilance Inspectors Working Group for 2016
This document is the ninth annual report of the Pharmacovigilance Inspectors Working Group. Read more
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New product information wording: extracts from PRAC recommendations on signals adopted at the 3-6 July 2017 PRAC
The product information wording in this document is extracted from the document entitled "PRAC recommendations on signals" which contains the whole text of the PRAC recommendations for product information update, as well as some general guidance on the handling of signals. Read more
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Update - CMDh Best Practice Guide on the use of eCTD in the MRP/DCP
Track version. Read more
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Transparency and data quality: new cross-cutting EFSA guidance in a nutshell
Two new guidance documents - on the weight-of-evidence approach and biological relevance assessment - will help to further harmonise methodologies across the areas in which EFSA works. Read more
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Questions and answers on production of water for injections by non-distillation methods – reverse osmosis and biofilms and control strategies
Read more
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USP monograph <1790>
The long-awaited new monograph <1790> of the US Pharmacopoeia about the visual inspection of injections, which is supposed to be an explanation for the already valid chapter <790>, will finally come into force on August, 1st. Read more
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IUCLID Cloud launched – simpler for smaller companies
The cloud version of the chemical data management tool IUCLID is now available for SMEs. Consultants helping SMEs with their registrations are welcome to subscribe too. In the cloud, you can prepare your REACH registration dossier directly online so there is no need for local installation. Reap the benefits of the cloud: data stored and safe at ECHA, automatic updates of IUCLID, fully managed back-ups, 24/7 availability of service. Read more
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Q&As on impact of EU-USA mutual recognition agreement on marketing authorisation applications and relevant variations
Read more
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API starting materials: EMA publishes updated reflection paper
In the recently published updated EMA reflection paper about starting materials, the passage about description of the manufacturing process of an API in an authorisation dossier has been revised. Read more
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Revised guideline on first-in-human clinical trials
The European Medicines Agency (EMA) has revised its guidance on first-in-human clinical trials to further help stakeholders identify and mitigate risks for trial partcipants. Read more
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 July 2017
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended eleven medicines for approval at its July meeting. Read more
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Ph. Eur. Supplement 9.3
Supplement 9.3 of the Ph. Eur. is now available. CEP holders are invited to update their applications according to the revised monographs that will be implemented on the 1st of January 2018, and to follow the instructions given in the document HERE. Read more
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Mutual recognition agreements
The European Union (EU) has signed mutual recognition agreements (MRAs) with third-country authorities concerning the conformity assessment of regulated products. Such agreements contain a sectoral annex on the mutual recognition of good manufacturing practice (GMP) inspections and batch certification of human and veterinary medicines. Read more
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EMA's updated Implementation Plan for the Introduction of Safety Features
The soon-to-be required safety features for the execution of the Falsified Medicines Directive have to be implemented by February 9th, 2019. The EMA has published an updated plan for the implementation of safety features on the packaging of centrally authorized products for human use. Read more
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Order no. 6289/2017 - National Official Journal no. 137/2017, Series II of 2017-07-18
Amends no. 4 of Order no. 5657/2017, published in National Official Journal, 2nd series, no. 123, of 28 June (clarifies the scope of application and establishes a quick and transparent procedure regarding the authorization applications underlying the provisions of article 9 of Decree-Law no. 5/2017, of 6 January). Read more
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Regulatory information – EMA improves its guidance for post-authorisation activities
The European Medicines Agency (EMA) has updated its best practice guidelines and support documents for marketing authorisation holders (MAHs) in the areas of type II variations, post-authorisation safety studies and changes related to quality aspects. Read more
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Questions and answers of scientific guidelineImproving the understanding of normal operating range (NOR), proven acceptable range (PAR), design space (DSp) and normal variability of process parameters. Read more
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What is GMP compliant Equipment Design?
It's frequent question what GMP compliant equipment design is or how a system has to be made up in order to be GMP compliant and suitable for the manufacturing of medicinal products/APIs. There is a short and a long answer to these questions around GMP compliant equipment design. Read more
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European Union individual case safety report (ICSR) implementation guide
This guidance specifies the technical requirements and the process of transmission of Individual Case Safety Reports (ICSRs) and is applicable to all stakeholders, which are exchanging ICSRs electronically within the EEA. Read more
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New tools to potentially reduce need for animal testing
EFSA recently launched its OpenFoodTox database of chemical hazards in food and feed. The database is a rich source of toxicological information for risk assessment that can potentially support the reduction of animal testing. Read more
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The launch of the new EudraVigilance system
This document addresses questions received from stakeholders in preparation of the launch of the new EudraVigilance System, which is to go-live on 22 November 2017. Read more
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Data on medicines (ISO IDMP standards)
The European Medicines Agency (EMA) is in the process of implementing the standards developed by the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP). Read more
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Targeted stakeholder consultation on the experience acquired with the Paediatric Regulation
Results of the public consultation on the Paediatric Regulation are now available. Read more
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EMA and EUnetHTA step up interaction to align data requirements
The European Medicines Agency (EMA) and the European Network for Health Technology Assessment (EUnetHTA) are stepping up their efforts to provide developers of medicines with simultaneous, coordinated advice on their development plans and facilitate alignment of data requirements. Read more
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Pharmeuropa: Texts for comments
Pharmeuropa issue 29.3 is now complete. Submit your comments before 30 September 2017. Read more
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Pre-submission checklist for type II variation applications
The Agency strongly recommends that this checklist is used in advance of submission of type II variation applications. You should be able to answer "Yes" to every item listed below unless a specific point is not applicable ("n/a") to the application in question. Please note that this checklist should not be included in the submission. Read more
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Decree-Law no. 5/2017, of 6 January – article 9 Establishments, Services and Bodies of the NHS and of the Ministry of Health and Communications Platform – Transparency and Advertising
Decree-Law no. 5/2017, of 6 January, which approves the general principles of advertising to medicinal products and medical devices, establishes specific rules regarding the scientific actions to be performed in establishments, services and bodies of the National Health System (NHS) and of the Ministry of Health (MH) and to the reception of support and benefits from these entities, as well as it also does some changes in the regimen of obligations of communications foreseen in article 159 of the Portuguese Medicinal Products Statute, approved by Decree-Law no. 176/2006, of 30 August, and in article 52 in Decree-Law no. 145/2009, of 17 June, recently become effective. Read more
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The MEDICRIME Convention in a few words
The EDQM plays a major role in implementing and monitoring the Council of Europe Convention on falsified medical products and similar crimes involving threats to public health, known as the MEDICRIME Convention. Read more
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EDQM publishes its 2016 Annual Report
The EDQM has just published its 2016 Annual Report. The report is an opportunity to review the different activities of the past year and reflect on what the EDQM accomplished and developed. In her foreword, EDQM Director, Dr Susanne Keitel, comments on the year's events, achievements, and thanks all involved for their dedication, expertise and support. Read more
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The user manual of EudraVigilance Web reporting tool EVWEB (version 1.0) is now available
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Two new medicines recommended for the treatment of chronic hepatitis C
The European Medicines Agency has recommended granting marketing authorisations in the European Union (EU) for Maviret and Vosevi, two new medicines indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults. Read more
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FDA Pediatric Cancer Panel Suggests More International Research Collaboration
In the second day of a two-day meeting, an FDA pediatric cancer advisory panel suggested further international cooperation and emphasized the need for tailoring trials to their specific diseases, while recommending against the use of placebos in pediatric cancer drug trials. Read more
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ICH M7(R1) Addendum reaches Step 4 of the ICH Process
The ICH M7(R1) Addendum reached Step 4 of the ICH process in May 2017 and now enters into the implementation period (Step 5). Read more
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Implementation of the Falsified Medicines Directive
Version 7 of "Questions and Answers" document regarding the implementation of the rules on the safety features for medicinal products for human use is now available. Read more
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Pharmacovigilance Legislation
The Q&A on the Pharmacovigilance legislation have been updated. Please find it in the track version of the document in force. Read more
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European Medicines Agency’s interaction with industry stakeholders - Annual report 2016
Read more
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SCCS - Request for a scientific opinion
Submission II on the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products. Read more
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Applications pilot: dedicated support for small and medium-sized enterprises
EFSA has launched a new support initiative for applicants from small and medium-sized enterprises (SMEs). In the next six month, SMEs in the areas of feed additives and novel foods (excluding traditional food) can request an administrative check of their draft dossiers prior to submission. The support will be provided via teleconferences. Read more
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REACH tests need to comply with good laboratory practice
ECHA reminds registrants that all toxicological and ecotoxicology tests need to be carried out in compliance with good laboratory practice (GLP). Read more
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Concept paper on the need for the development of a reflection paper on regulatory requirements for the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH)
Draft: consultation open Read more
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Regulatory guidance for industry to prepare for the UK’s withdrawal from the EU
The European Medicines Agency (EMA) and the European have published guidance to help pharmaceutical companies to prepare for the United Kingdom´s withdrawal from the European Union. The guidance relates to both human and veterinary medicines. Read more
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Substance not in the review programme? Check if you can still use it
A list of those active substances not covered by the review programme that can continue to be used in biocidal products is now available. Read more
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Simplex + 2016 Program
Infarmed has implemented 9 measures within the scope of the Simplex + 2016 Program. Read more
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Drugmakers Seek Clarifications of FDA’s Interchangeability GuidanceMore drugmakers have weighed in on the FDA´s draft guidance on biosimilar interchangeability, urging the agency to make clear the designation does not mean a product is superior in terms of safety or efficacy. Read more
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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
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Decide if your product is a medicine or a medical device
How the Medicines and Healthcare products Regulatory Agency (MHRA) makes decisions on what is a medicine or medical device (borderline products). Read more
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European Pharmacopoeia: supplements 9.1 to 9.5 and new downloadable version available to order
Supplements 9.1 to 9.5 of the European Pharmacopoeia are now available to order on the EDQM store. These supplements, which are expected to be ready for dispatch during June, contain all the regulatory information that will come into force in the course of 2018. They complement the 9th Edition launched last year and bring the total number of monographs to 2351 (including dosage forms), along with 361 general texts (including general monographs and methods of analysis) and around 2670 descriptions of reagents. Read more
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EudraVigilance
EMA will launch a new EudraVigilance system with enhanced functionalities for reporting and analysing suspected adverse reactions in November 2017. Read more
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Chemistry of active substances (chemistry of new active substances)
This document describes the type of information required for the manufacture and control of active substances (existing or new chemical entities) used in a medicinal product. Effective from 21/05/2017. Read more
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May Newsletter published
In the May issue of the ECHA Newsletter, you can read expert views on how close we are to end animal testing, how safe artificial pitches are and how you can now find safer chemicals online. Read more
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EudraVigilance Data Analysis System (EVDAS)
User registration steps for EU QPPVs or trusted deputies (for the purpose of the EudraVigilance registration process). Read more
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European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes
This guidance document addresses a number of questions which marketing authorisation holders (MAHs) may have on post-authorisation procedures. It provides an overview of the Agency´s position on issues, which are typically addressed in discussions or meetings with MAHs in the post-authorisation phase. Read more
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Report of the consultation - Public consultation on strengthening EU cooperation on Health Technology Assessment (HTA)
Read more
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Ordinance no. 111/2017 - National Official Journal No. 93/2017, Series II of 2017-05-15
Adds the annex to Ordinance no. 158/2014, of 21 February, which reviews the special reimbursement regimen for medicinal products meant for the treatment of the hepatitis C disease, adding the medicinal product containing the substance Sofosbuvir + Velpatasvir. Read more
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Progress on science, medicines and health
The European Medicines Agency's (EMA) 2016 annual report focuses on the Agency's key achievements in the areas of medicine evaluation, support to research and development of new and innovative treatments and the safety monitoring of medicines in real life. Read more
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Nitrogen Use in pharmaceutical Production
Nitrogen often comes in contact with a product during manufacturing and is therefore relevant for its quality, especially when it comes to the manufacture of sterile products. Nonetheless, the use of nitrogen is significantly less specified than that of pharmaceutical water. Parameters and limits have to be defined by the pharmaceutical users themselves. Read more
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Press Release – Ministers of six countries sign unprecedented agreement for access to medicinal products
The Ministers of Health of six European countries, including the Minister of Health Adalberto Campos Fernandes, signed yesterday the La Valletta Declaration, an unprecedented agreement that aims to ensure patient access to innovative medicinal products and, at the same time, the sustainability of the healthcare systems. Read more
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Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices
Amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. Read more
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Now Official: Revised USP Plastic Packaging Chapters <661.1> and <661.2>
The USP Expert Committee General Chapters - Packaging and Distribution posted on April 28, 2017, the previously announced Revision Bulletins, Postponement, regarding general chapters <659>, <661>, <661.1> and <661.2>. The revisions of the four general chapters have become official on May 1, 2017. Read more
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Draft Addendum of the ‘ICH E11(R1) guideline on clinical investigation of medicinal products in the paediatric population’ (EMA/CPMP/ICH/2711/1999)
Overview of comments received by the European Medicines Agency Read more
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Drug Safety Update: monthly newsletter
Monthly PDF editions of the
Drug Safety Update newsletter from MHRA and its independent advisor the
Commission on Human Medicines.
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Instruction document of the Spanish Agency for Medicinal Products and Medical Devices for conducting clinical trials in Spain
In this instruction document of the Spanish Agency of Medicinal Products and Medical Devices for conducting clinical trials in Spain is provided, in a questions and answers format, information on the practical aspects that entail the application of the Royal Decree 1090/2015, of 4 December, highlighting the differences concerning the previous royal decree. Read more
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PUBLISHING OF THE GLOBAL STATISTIC DATA OF THE YEAR 2016 (RESULTS ON 31/12/2016)
The global statistic data of the year 2016 (results on 31/12/2016) are published, available in the spacer Indicators CEIC. The indicators regarding Clinical Trials with Medicinal Products, Clinical Trials with Intervention of Medical Devices and Financial Contracts of Studies approved by CEIC are available. Read more
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Draft guideline on good clinical practice compliance in relation to trial master file (paper and/or electronic) for content, management, archiving, audit and inspection of clinical trials
Draft: consultation open Read more
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What's new in Pharmacovigilance - QPPV Update - Issue 1 - 2017
This is the first issue of QPPV Update in 2017. It provides Qualified Persons responsible for Pharmacovigilance (QPPVs) and all other people working in pharmacovigilance with an update on EU Pharmacovigilance. Read more
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Position (EU) No 2/2017 of the Council at first reading
Adoption of a Regulation of the European Parliament and of the Council on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC Read more
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FDA approves two hepatitis C drugs for pediatric patients
The U.S. Food and Drug Administration approved supplemental applications for Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) to treat hepatitis C virus (HCV) in children ages 12 to 17. Harvoni and Solvaldi were previously approved to treat HCV in adults. Read more
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Optimising safety information for medicines in Europe throughout product lifecycle
Following two years of experience with safety monitoring of nationally authorised medicines via the single assessment of periodic safety update reports (PSURs), the European Medicines Agency (EMA) has issued additional guidance and recommendations as part of its commitment to continuous process improvement. Read more
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EMA revises Guide on Pharmaceutical Water
According to the European Pharmacopoeia, it is allowed as of the 1st of April 2017 to produce water for injection (WFI) using cold i.e. non-distillation methods. Now, the European Medicines Agency EMA has published a concept paper on the revision of the "Note for Guidance on Quality of water for pharmaceutical use". Read more
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PRAC recommendations on signals adopted at the PRAC meeting of 6-9 March 2017
Adopted Read more
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CMDh Best Practice Guidance on collaboration between Member States in relation to serious GMP non-compliance issues
The aim of this Best Practice guide is to facilitate the collaboration among MSs in the Coordination Group for Mutual Recognition and Decentralised Procedure (human), CMDh, on serious GMP issues notified to the group. Read more
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Good pharmacovigilance practices
Good pharmacovigilance practices (GVP) are a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (EU). GVP apply to marketing-authorisation holders, the European Medicines Agency and medicines regulatory authorities in EU Member States. They cover medicines authorised centrally via the Agency as well as medicines authorised at national level. Read more
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CMDh procedural advice on changing the RMS
In exceptional circunstances, a Marketing Authorisation Holder (MAH) may request a change of the Reference Member State (RMS). Read more
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EMA Q&A on GCP
The European Medicines Agency (EMA) recently published Questions and Answers on good clinical practice (GCP) on its website. Read more
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Scientific guidelines with summary-of-product-characteristics recommendations
Update Read more
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COMMISSION IMPLEMENTING REGULATION (EU) 2017/556, of 24 March 2017, on the detailed arrangements for the good clinical practice inspection procedures pursuant to Regulation (EU) No 536/2014 of the European Parliament and of the Council
Text with EEA relevance Read more
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Use of big data to improve human and animal health
Together with the heads of the national competent authorities in the European Economic Area (EEA), known as Heads of Medicines Agencies (HMA), the European Medicines Agency (EMA) has established a new task force to explore how medicines regulators in the EEA can use big data to support research, innovation and robust medicines development in order to benefit human and animal health. Read more
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New portal “Information System for the Assessment of the Health Technologies – SIATS”
As from today, 23rd March, the new SIATS (Information System for the Assessment of the Health Technologies) portal is available, which will allow the MA holders and their representatives to manage the medicinal products accessibility. Read more
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Annex 16 QP Certification: important Questions and Answers
What can a Supply Chain Diagram look like? How to rely on vendor-supplied samples? These are just two examples of questions being frequently asked in connection with the new Annex 16 of the EU-GMP Guidelines (Certification by a Qualified Person and Batch Release). Read more
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Agenda - CHMP agenda of the 20-23 March 2017
Draft agenda for the meeting on 20-23 March 2017 Read more
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2016 annual report on EudraVigilance for the European Parliament, the Council and the Commission
This Annual report is prepared in accordance with EU legislation and summarises the EudraVigilance related activities performed in 2016. Read more
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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
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Launch of SPOR data management services
The European Medicines Agency (EMA) is preparing data management services in the four domains of master data in pharmaceutical regulatory processes: substance, product, organisation and referential (SPOR) data. The SPOR services will support the implementation of the standards developed by the International Organization for Standardization (ISO) for the identification for medicinal products (IDMP). Read more
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EMA Paper on Dissolution Specification for Generic Products published
The EMA published the draft of the "Reflection paper on the dissolution specification for generic oral immediate release products". Read more
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Variations to the terms of MA: National Procedure
Frequently Asked Questions - National Variations Read more
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Regulatory cooperation to improve global health
How to improve the availability of high quality, safe and effective medicines to patients in countries beyond Europe and how to make better use of existing tools? These were two of the questions discussed at a workshop jointly organised by the European Medicines Agency (EMA) and the Maltese Presidency of the European Union (EU) that brought together regulators from across the EU and Africa in Malta on 2 and 3 March 2017. Read more
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EC Report Recommends Policy Actions on Off-Label Use
Regulations on off-label use are not harmonized across the European Union - only 10 out of 21 surveyed member states have specific policies, according to a European Commission report Read more
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Implementation strategy of ICH Q3D guideline
The purpose of this document is to address specific considerations to enable the practical implementation of ICH Q3D Guideline for Elemental Impurities in the European Union. Read more
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Sterile plastic containers for human blood and blood components
A draft of Ph. Eur. chapter 3.2.3 Sterile plastic containers for human blood and blood components has been published for comments in Pharmeuropa 29.2. Deadline for comments is June 30, 2017. Read more
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Concept paper on the need for revision of note for guidance on quality of water for pharmaceutical use (H+V)
Draft: consultation open Read more
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CEIC Guideline on the SUPPLY OF THE MEDICAL DEVICE IN THE SCOPE OF CLINICAL STUDIES WITH INTERVENTION
In the CEIC website, in the spacer Guidelines the CEIC Guideline on the SUPPLY OF THE MEDICAL DEVICE IN THE SCOPE OF CLINICAL STUDIES WITH INTERVENTION is published. This document was approved in plenary meeting on 20th February and published on 24th February. Read more
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Mutual recognition with the United States
Authorities in the European Union (EU) and the United States (US) have put in place a mutual recognition agreement (MRA) on good manufacturing practice (GMP) inspections. The aim of the agreement is to encourage greater international harmonisation, make better use of inspection capacity and reduce duplication. Read more
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PRIME: priority medicines
PRIME is a scheme launched by the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need. This voluntary scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimise development plans and speed up evaluation so these medicines can reach patients earlier. Read more
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Delegate Regulation on the Anti-Counterfeiting Directive
New EU Requirements and State of Implementation
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Adaptive Pathways
Report on a meeting with stakeholders held at EMA on Thursday 8 December 2016. Read more
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Best Practice Guide on the Assessment Report for Mutual Recognition and Decentralised Procedures
Update Read more
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New downloadable version of the European Pharmacopoeia
With the publication of Supplement 9.3 the USB version of Ph.Eur. will be replaced by a downloadable version. Read more
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The ICH Q11 draft Q&A presentation available now on the ICH website
The ICH Q11 Questions and Answers (Q&As) on the Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities), regarding the selection and justification of starting materials, reached Step 2b of the ICH Process in November 2016 and now enters the consultation period. A training presentation has also been developed by the expert Working Group. Read more
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Questions and answers: Good manufacturing practice
European Medicines Agency´s answers to frequently asked questions, as discussed and agreed by the Good Manufacturing Practice (GMP) / Good Distribution Practice (GDP) Inspectors Working Group (Update). Read more
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Concept paper on developing a guideline on quality requirements of medicinal products containing a device component for delivery or use of the medicinal product
Draft: consultation open Read more
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EDQM on biosimilars: Ph. Eur. monographs are flexible and evolving standards
During a seminar coorganised with the European Medicines Agency (EMA), the EDQM clarified further the role that Ph. Eur. monographs play in the assessment of biosimilars. As public standards for the quality of medicines in Europe, monographs ensure the quality of biosimilar and other biotherapeutic products, but compliance with them is not sufficient for demonstrating biosimilarity. However, while Ph. Eur. monographs provide specifications in the form of tests and acceptance criteria for all medicines, they are dynamic documents that can be adapted to scientific progress. Read more
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Ordinance no. 1542/2017 – National Official Journal no. 33/2017, Series II of 2017-02-15
Defines the concept of "insignificant valuables and relevant for the practice of the healthcare professional " providing its uniform fixation, in the scope of the sectors of the medicinal product and of the medical devices. Read more
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Revised document published on Management of applications for new CEPs and revisions/renewals of CEPs.
The document PA/PH/CEP (13) 110 which described the policy for assessment of CEP applications has been revised following a review of current practice. Read more
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Press Release – Europe begins safety assessment of quinolones (antibiotics)
The European Medicines Agency (EMA) began the safety review of the quinolones and fluoroquinolones, which are broad spectrum antibiotics used in the treatment of severe bacterial infections. The purpose of this review - which originated a newsletter published at Infarmed´s website - is to assess the duration of severe adverse reactions that affect the muscles, the joints and the nervous system. Read more
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New MedRegs blog
MHRA has launched an official blog providing expert insight into the latest regulatory thinking and all aspects of medicines regulation. Read more
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Annual report on the use of the special contribution for orphan medicinal products
Patients suffering from rare diseases deserve access to the same quality of medicinal products as other patients within the European Union (EU). The incentives laid down in the orphan legislation aim to simulate sponsors to develop medicinal products for rare diseases. Medicinal products eligible for incentives are identified throught the EU procedure of orphan designation. The orphan designations cover a wide variety of rare diseases, including genetic diseases and rare cancers, for which there are limited treatment options, a large |