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  • Novidades 13 de Abril 2020 0

Medicines for Europe


Launch of GMP inspection management in IRIS - Recording of training available

Following the go live of Inspections GMP and the Industry training held on the 10th of September, EMA has informed us that the video which was created after this training has been uploaded to the IRIS website (guidance & support) and can now be viewed.

Even though GCP has not been launched yet, this subject is also covered in the training.”



EFPIA – European Federation of Pharmaceutical Industries and Associations


(no new develpoments)



EC – European Commission


European Health Union: Commission establishes portfolio of 10 most promising treatments for COVID-19

Delivering on a key action from the EU Strategy on COVID-19 Therapeutics, the Commission is today establishing a portfolio of 10 potential COVID-19 therapeutics. The list established is based on independent scientific advice, and focuses on COVID-19 treatment candidates that are likely to be authorised and therefore available on the European market soon.


Questions and answers on the list of 10 candidate COVID-19 therapeutics


International health resilience: A defining challenge

The G20 leaders’ meeting in Rome is one of the most important in recent years. If not in its history.

COVID-19 is the most serious crisis since the end of the Second World War. And the leaders of the largest economies have a particular responsibility to shape the post–COVID-19 world and to coordinate international action on the major challenges in its aftermath.”



ECA – European Compliance Academy GDP Association


GLP: New Data Integrity Guideline

“Recently, the so-called "OECD SERIES ON PRINCIPLES OF GOOD LABORATORY PRACTICE AND COMPLIANCE MONITORING" document No. 22 was added to the series of available Data Integrity Guidelines in the GLP sector. Industry comments on this GLP paper were collected and partially incorporated in the summer of 2020. The draft was still strongly based on the MHRA guideline (2018), the final version hardly at all.”


Inspection Deficiencies in Process Equipment increase

“The evaluation of the last year 2020 shows a significant increase in inspection deficiencies with regard to equipment.  This includes defects in equipment design, size, placement, and deficiencies in maintenance and cleaning. In 2019, equipment still ranked 11th on the list of drug observations. In 2020, process equipment moved up to No. 5 - followed by No. 6, which again separately lists deficiencies in maintenance and cleaning.”


Is Bracketing/Matrixing Acceptable During Generic Drug Development?

The Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) has published a Draft Guidance for Industry entitled “Questions and Answers on Quality Related Controlled Correspondence". The document provides FDA's current thinking on quality-related scientific and regulatory topics that appear frequently in controlled correspondence submissions. It contains, besides other topics, questions and answers related to bracketing and matrixing.


GMP Inspections: Do you know IRIS?

“IRIS is an online platform for handling product-related scientific and regulatory procedures with the EMA. In 2018, it was established in a first step for orphan drug procedures. It was then expanded step by step. The aim is to shorten the time of applications within the framework of scientific procedures.”


New Limits for Heavy Metals in Food Supplements

“The European Commission sets new limits for Cadmium and Lead in certain Foodstuffs and Food supplements. Products placed on the market before the entry into force of the new regulations and not complying with the new maximum levels should only be allowed to remain on the market for a limited period of time.”


New Updates of the Templates for Reporting Nitrosamine Contamination

“Marketing authorisation holders of chemically-synthesized or biologic medicinal products are required to perform confirmatory testing after identifying a potential risk of nitrosamine contamination and report the results using specified templates. One of these reporting templates has been recently revised.”





Global Pharmaceutical and Biotechnology Conference - 08.11.2021 - 10.11.2021


CEP holders invited to comment on draft monographs published in in Pharmeuropa 33.4

“Holders of Certificates of suitability to the monographs of the European Pharmacopoeia (CEPs) are requested to consult the list of substances for which draft revised monographs of the European Pharmacopoeia (Ph. Eur.) have been published in Pharmeuropa 33.4. The table below lists the substances affected by these revisions and for which a CEP has been granted.”


EDQM Virtual Training Programme: independent modules on Ph. Eur., Reference Standards and CEP Procedure


“The training will focus on chemically defined active substances and cover all the fundamentals related to the use of the European Pharmacopoeia and its reference standards, as well as the procedure for Certification of suitability to the monographs of the European Pharmacopoeia (CEP).”


European Pharmacopoeia device version to be discontinued

The European Directorate for the Quality of Medicines & HealthCare (EDQM) will discontinue the device version of the European Pharmacopoeia (Ph. Eur.) as of the 11th Edition, which is scheduled for publication in July 2022, and focus efforts on the online and paper versions



EMA – European Medicines Agency


Medicines under additional monitoring: Annex XIII - List of Valproate and related substances in the European Union (updated)


Medicines under additional monitoring: List of medicinal products under additional monitoring (updated)


Medicines under additional monitoring: Annex IX - List of combined hormonal contraceptives containing chlormadinone in the European Union (updated)


Updated draft technical documents for eAF v1.26.0.0 now available

“Updated draft DES summary and draft XSD files for the Vet MAA and variation forms are now available.”


Updated renewal form and veterinary maa eAF v1.25.0.0 now available

“Updated versions of the renewal form and the vet maa form v1.25.0.0 are now available on the eAF website. There is no change in the version number. This is a bugfix update to fix 2 minor technical bugs which do not affect all users.”


Scientific guideline: Guideline on registry-based studies

PRAC recommendations on safety signals (updated)


Regulatory and procedural guideline: PRIME eligibility requests: 2022 deadlines for submission and timetable for assessment


Integration of EudraGMDP and OMS - Webinar for industry , Online, 14:00-16:30 (CEST), from 12/10/2021 to 12/10/2021 (updated)


Periodic safety update single assessment: Intravenous iron: List of nationally authorised medicinal products - EMEA/H/N/PSR/J/0026


Periodic safety update single assessment: Intravenous iron: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - EMEA/H/N/PSR/J/0026


Regulatory and procedural guideline: Compilation of Union procedures on inspections and exchange of information (updated)


Referrals document: Nitrosamines EMEA-H-A5(3)-1490 - Questions and answers for marketing authorisation holders / applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products (updated)


Report: Final feedback from European Medicine Agency (EMA) to the EU Commission request to evaluate the impact of the removal of titanium dioxide from the list of authorised food additives on medicinal products

“Considering the scale of the use of this excipient, the time and costs involved in the reformulation and the volume of products impacted, it is considered that any requirement to replace TiO2 in medicines will almost certainly cause significant medicines shortages and discontinuations/withdrawals of medicines from the EU/EEA market with major implications for patients and animals. Particular concerns arise in relation to certain vulnerable classes/types of products such as paediatric medicines, orphan medicines, low sales volume products, bee products, etc.).”





(no new develpoments)






Report from the CMDh meeting held on 12-13 October 2021





ICH 30th Anniversary Publication – ICH - the global platform for harmonisation

“ICH is pleased to announce the publication of a 30th Anniversary document. This follows ICH’s 2020 celebration of 30 years of harmonisation activity. It provides an overview of ICH’s history and current work, as well as views of different stakeholders on how ICH has contributed to better health and ICH’s future directions in the next 10 years.”





EMA promove formação para futuros utilizadores do novo Portal Europeu de Ensaios Clínicos

Com a entrada em aplicação do Regulamento Europeu de Ensaios Clínicos 536/2014 de 16 de abril a 31 de janeiro de 2022, entrará em funcionamento o novo Portal Europeu de Ensaios Clínicos, o Clinical Trial Information System (CTIS). Este portal tornará possível a submissão única, a nível europeu, de pedidos de autorização de ensaios clínicos, e será a interface de registo de informação e comunicação entre promotores de ensaios clínicos e Estados-membros, permitindo simultaneamente a divulgação publica de informação de ensaios clínicos que decorrem na União Europeia.



Diário da República


(no new develpoments)





China | Decretos 248 e 249 (2021- Alterações das Medidas administrativas para a Exportação (email attached)

“A APARD recebeu via DGAV a informação relativa à revisão das regras de exportação para a China, que está a exigir às Autoridades Competentes dos Países, que registem as empresas que estão a exportar para aquele destino, os produtos que constam do anexo em excel ANEXO -2 e onde estão incluídos suplementos alimentares.


RP China reviu as suas “Medidas Administrativas sobre Segurança Alimentar na Importação e Exportação” que resultou nos Decretos 248 e 249, que entrarão em vigor a 1 de janeiro de 2022, decretos que cobrem uma vasta gama de requisitos sobre exportações de alimentos para aquele destino prevendo alterações que são causa de preocupação transversal a todos os EM e países terceiros (os documentos em anexo são traduções não oficiais).


Desta forma todos as empresas que exportam estes produtos para a China devem enviar-nos essa informação até ao dia 26/10 para podermos comunicar à DGAV que  posteriormente irá registar as empresas nacionais na plataforma e enviar a informação às Autoridades Chinesas, via Embaixada.”


APARD - Primeira opinião da Comissão Europeia ao abrigo do novo Regulamento de Reconhecimento Mútuo_Rede SOLVIT

No passado mês de setembro, a Comissão Europeia (CE) adotou o primeiro parecer sobre a aplicação do princípio do reconhecimento mútuo e os requisitos do Regulamento (UE) 2019/515 (Regulamento de Reconhecimento Mútuo)*. Este é o primeiro parecer da Comissão com base no procedimento SOLVIT, conforme previsto no art. 8º do Regulamento de Reconhecimento Mútuo (procedimento de resolução de problemas), que entrou em vigor a 19 de abril de 2020.


Este procedimento de resolução de problemas visa reforçar a aplicação do princípio do Reconhecimento Mútuo e simplificar a venda de produtos dentro da UE, que são legalmente comercializados noutro Estado-Membro (EM), mas não estão sujeitos à harmonização da UE.”



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