Voltar 12 ago 2021
  • Novidades 17 de Janeiro de 2020 0

Medicines for Europe


(no new develpoments)



EFPIA – European Federation of Pharmaceutical Industries and Associations


EFPIA response to the European Commission's consultation on the revision of EU rules on medicines for children and rare diseases




ECA – European Compliance Academy



Deficient Cleaning and Transfer of a Non-Validated Manufacturing Process Lead to a Warning Letter


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


Recently, the European Commission published a so-called "balanced package" of measures to solve some of the most pressing problems related to the implementation of the Protocol on Ireland and Northern Ireland (NI). So now this document, with a total of 13 points, including proposed solutions, when regulatory compliance functions for medicines authorised nationally by the UK for Northern Ireland may also be localised in Great Britain (GB) in exceptional cases.



Nitrosamine Impurities: FDA Rejects the Extension of Deadline for Submission of Risk Assessments


The arguments of the industry representatives could not convince the FDA. The extension of the deadline was rejected on the following grounds:

  • In the past, concessions were made to manufacturers who had detected nitrosamines in their products above the AI limits. This flexibility on the part of the FDA allowed for continued marketing of batches to reduce the risk of supply shortages. A case-by-case evaluation for each drug product for the purpose of a risk-benefit trade-off by the agency will continue to be conducted in close collaboration with manufacturers.



FDA Analyses Products from Amazon and Finds Potentially Harmful Drug Ingredients



Remote Audits from the Perspective of Notified Bodies


We have already reported on the experiences of notified bodies regarding remote audits in the past. Recently, the results of a survey addressed to Notified Bodies on remote audits have been published.



EMA publishes updated Question and Answer Document on Combination Products


‘’(...)new requirements have been/will be imposed on combination products (products containing a medicinal product and a medical device) with regard to their medical device component. There is a question-and-answer document (Q&A) from the European Medicines Agency (EMA) that has been updated to address current issues."



Finally published: Reflection Paper on GMP and Marketing Authorisation Holders


The content of the document is GMP responsibilities that apply to Marketing Authorisation Holders. As not all Marketing Authorisation Holders (MAH) are also manufacturers and have a Manufacturing/ Import Authorisation (Manufacturing/ Import Authorisation Holder, MIAH), the aim here is to provide clarity on the different responsibilities and their practical significance for MAHs. (ver anexo)







New publication on an EDQM Biological Standardisation Programme study for standardisation of allergen products

Following the successful completion of the BSP090 study on recombinant major allergens, in collaboration with project leaders from the Paul-Ehrlich-Institut, an article on one of the major study outcomes “Validation of a candidate European Pharmacopoeia standard method for quantification of major grass pollen allergen Phl p 5” has recently been published in the scientific journal Allergy.







EMA – European Medicines Agency



Other: European Medicines Agency’s Privacy Statement: Small and Medium Enterprises (SME) Office activities (updated)



Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5 August 2021



Interoperability of track and trace systems: key to public health protection



Pharmacovigilance Risk Assessment Committee (PRAC)



Newsletter: Human medicines highlights - August 2021



PRAC recommendation on signal: New product information wording: extracts from PRAC recommendations on signals Adopted at the e 5-8 July 2021 PRAC meeting



PRAC recommendation on signal: PRAC recommendations on signals adopted at the 5-8 July 2021 PRAC meeting



Other: List of signals discussed at PRAC since September 2012 (updated)



Regulatory and procedural guideline: Checklist for annual updates for parallel distribution: guidance for industry (updated)



Regulatory and procedural guideline: Checklist for initial notifications for parallel distribution: guidance for industry (updated)



Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes (updated)



Signal management (updated)








FDA Participates in New ‘Collaborative Communities’ to Address Emerging Challenges in Medical Devices







GDP Association


(No new developments)








(No new developments)









29 July 2021










(No new developments)







Atualização das listas previstas no Regulamento sobre notificação prévia de transações de medicamentos para o exterior do país



Sistema europeu de ensaios clínicos lançado em janeiro






Diário da República


Deliberação n.º 810/2021 - Sumário: Estabelece em que condições é possível prescindir das embalagens de medicamento destinadas a teste terapêutico.



Decreto-Lei n.º 69/2021168697992


Proíbe a colocação no mercado de determinados produtos cosméticos e detergentes que contenham microesferas de plástico.

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