Voltar 01 fev 2021
  • Novidades 31 de Julho de 2019 0


(No new developments)





Combination Products in the USA

Combination products in the US are separately regulated by the FDA via GMP regulations. A dedicated FDA website provides guidance on combination products.


Survey Results on "Remote Audits" of Notified Bodies

Within the framework of a survey via the EU Commission, Notified Bodies in the medical devices sector were asked about their experiences with "remote audits". The results are now available.


Updated Timeline for the Clinical Trial Regulation

The EMA is still planning with December 2021 as the date for the first application of the Clinical Trial Regulation (CTR). Initial information on the schedule was published in December.


Janet Woodcock new FDA Acting Commissioner

When the new US President Biden took office, the previous FDA Commissioner resigned from his position. Now, Dr Janet Woodcock was named Acting FDA Commissioner.


Revision of USP Plastic Materials

The USP Packaging and Distribution Expert Committee intends to revise USP chapter Plastic Materials of Construction. The targeted official date is 1 March 2021.


EMA: Updated Q&A documents on Centralised Procedures

The "Q&A" documents for centralised procedures were revised and published on the EMA website in January. In general, pre- and post-approval advices regarding centralised procedures are given and specially information for applicants of generic or hybrid medicinal products is mentioned.






Implementation of risk assessment requirements to control elemental impurities in substances for veterinary use

The European Pharmacopoeia (Ph. Eur.) general monograph Pharmaceutical preparations (2619) requires manufacturers of products outside the scope of general chapter 5.20 to control the levels of elemental impurities in products using the principles of risk management. As of 1 January 2021, this applies to veterinary medicinal products, and new marketing authorisation applications submitted in the European Union for veterinary medicinal products must comply with specific risk assessment requirements for the control of elemental impurities.


CEP holders invited to comment on draft monographs published in Pharmeuropa 33.1

CEP holders are requested to consult the list of substances for which draft revised monographs of the European Pharmacopoeia (Ph. Eur.) have been published in Pharmeuropa 33.1. The table below lists the substances affected by these revisions and for which CEPs have been granted.


Implementation of the European Pharmacopoeia Supplement 10.5 – Notification for CEP holders

Supplement 10.5 of the European Pharmacopoeia (Ph. Eur) is now available. CEP holders are invited to update their applications according to the revised monographs that will be implemented on 1 July 2021, and to follow the instructions given below.





Committee for Medicinal Products for Human Use (CHMP): 25-29 January 2021 ,Virtual meeting, from 25/01/2021 to 29/01/2021 (updated)


Report: Meeting summary - PCWP/HCPWP meeting with all eligible organisations: COVID-19 pandemic update (new)


Agenda: Agenda - PDCO agenda of the 26-29 January 2021 meeting (new)

Marketing authorisation holders who are unable to transfer their batch testing site from the UK to the EU27/EEA by the date of Brexit may be permitted, for a limited period of time, to continue relying on quality control testing performed in the UK after Brexit. The transfer shoud be completed quickly and in principle by the end of 2019 at the latest.


International Coalition of Medicines Regulatory Authorities (ICMRA) (updated)





Coronavirus (COVID-19) Update: FDA Takes Action to Place All Alcohol-Based Hand Sanitizers from Mexico on Import Alert to Help Prevent Entry of Violative and Potentially Dangerous Products into U.S., Protect U.S. Consumers




Distribution of Temperature-Sensitive Pharmaceuticals: Requirements according to the EU GDP-Guidelines

With the approvals of various COVID-19 vaccines in many countries, the question arises how to safely transport the serum from the production sites to the storage and distribution centres and then on to the local vaccination centres. However, this question does not only arise for COVID-19 vaccines, but also any other temperature-sensitive product in general. 

The EU GDP-Guidelines contain some specific requirements for temperature-sensitive products in this regard.


New MHRA Inspectorate Blog GDP Post: Be aware of Fake Websites when Qualifying New Customers and Suppliers Using Online Resources

Qualification and re-qualification of suppliers and customers are a fundamental part of Good Distribution Practice (GDP). Using online resources and publicly available databases is established as a standard requirement during this process. But relying (only) on information that is easily available to everyone may involve a high risk. In this context, a new post, entitled “Qualifications of suppliers and customers online: reliable or fake news?” has been published in the MHRA Inspectorate blog.





(No new developments)






List of safety concerns per approved Risk Management Plan (RMP) of active substances per product (January 2021)







(No new developments)






Monitorização da disponibilidade de oxigénio

No quadro da resposta à pandemia e do aumento de procura de serviços de saúde, o Infarmed monitoriza o consumo de medicamentos, incluindo oxigénio, em estreita articulação com os titulares de Autorização de Introdução no Mercado (AIM) e os hospitais.


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

Foi publicada a Circular Informativa n.º 010 relativa a Publicação no Infomed de RCM e FI decorrentes da finalização de alterações clínicas e renovações em que Portugal atua como Estado membro Envolvido (PT-EME) – Retificação da Circular informativa nº 191/CD/100.20.200 de 16/12/2020 (em anexo).


Despacho n.º 1053/2021 - Diário da República n.º 17/2021, Série II de 2021-01-26

Define as especificações técnicas a que deve obedecer o gel desinfetante cutâneo para que possa beneficiar de incentivos fiscais.




EFPIA-Vaccines Europe statement on COVID-19 vaccines distribution

We understand the frustration caused by recent reporting on reductions to the quantities of COVID-19 vaccines being delivered to the European Union.




(No new developments)






On 24 December 2020, the European Union (EU) and the United Kingdom (UK) agreed on a provisional Trade and Cooperation Agreement which is about an economic partnership and trade regulations and stablished a few regulations related directly to medicinal products, including a dedicated annex (TBT-2: Medicinal Products).

Partilhe este artigo nas redes sociais