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Information on batch testing of medicinal products in the context of withdrawal of the United Kingdom from the Union

It is essential that marketing authorisation holders use the remaining time to complete their preparations so that by 1 January 2020 all batch testing facilities are fully transferred to the EU27/EEA and the necessary regulatory submissions are completed.


Updated version - Volume 2C: Guideline on the categorisation of New Applications (NA) versus Variations Applications (V) (Eudralex Volume 2C - Regulatory Guideline)


Updated version - Chapter 1: Marketing Authorisation (Eudralex Volume 2A - Procedures for marketing authorisation)





WHO publishes Draft Guideline on Production of WFI using Non-Distillation Methods

The WHO has reacted to the changes in the European Pharmacopoeia by issuing a draft guideline on the production of WFI (Water for Injection). The commentary phase is open to the public, comments can be submitted until 20 September 2019.


Brexit: Industry should keep Timelines for Batch Testing Facilities

The EMA points out that - independent from the Brexit postponement - MAHs should use the remaining time to complete all necessary preparations.


Warning Letter: Serious Defects in Zoning, Cleaning and Disinfection and Monitoring

The US FDA issued a Warning Letter to a US company with aseptic production due to serious deficiencies in room zoning, personnel, environment monitoring and disinfection.


EMA publishes Draft on Quality Requirements for Combination Products

The European Medicines Agency (EMA) has published a draft guideline on quality requirements for combinations of medicinal products and medical devices (so-called Drug Device Combinations - DDCs). What does the draft contain?


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.


Defect Catalog for Films and Foils

A technical guide on commonly used insulation materials has recently been provided in form of a stimuli article in Pharmacopeial Forum. In particular, a defect catalog for common thermal system components with detailed examples of potential failures is provided.


Recent Changes to the USP - What You Need to Know

The USP is currently introducing some changes to the format of the USP and to its online platforms. Amongst others the USP plans to discontinue printing the USP-NF in the current format.


French pilot programme for medical cannabis

The objective of the French pilot programme is to follow the recommendations of the CSST to evaluate cannabis prescribing and dispensing, and to collect safety and efficacy data. However, medical cannabis is not expected to be legalized in France prior to the end of 2021.


Updated Version of the Clinical Trials Regulation Questions & Answers Paper

The European Commission (EC) published an updated Version 2 of the Questions & Answers relating to the Clinical Trials Regulation. In particular, 47 Q&As on safety have been included.


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.





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.


As of 1 January 2020 the eCTD is mandatory for ALL CEP 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.


The Ph. Eur. revises its general chapter on UV-Vis absorption...

At its 162nd session in November 2018, the Ph. Eur. Commission adopted a new version of one of its major general methods. Ultraviolet and visible absorption spectrophotometry (2.2.25) has undergone extensive revision and is published in the 10th Edition (implementation date 1 January 2020).




Public consultation on key principles for the electronic product information of EU medicines

Stakeholders and members of the public are invited to submit comments on these key principles via an online form until 31 July 2019.


Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 July 2019

EMA’s human medicines committee (CHMP) recommended five medicines for approval at its July 2019 meeting.


Updated guidance for industry on preparing for Brexit

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.



(No new developments)




(No new developments)




June 2019 CMDh Minutes





Update: 25 July 2019


Exemption for batch testing of medicines in UK



UPDATE - List of safety concerns per approved Risk Management Plan (RMP) of active substances per product


UPDATE - "Blue-box" requirements





E8(R1) Public Stakeholder Meeting

ICH is announcing a public meeting entitled “ICH Global Meeting on E8(R1) Guideline on General Considerations for Clinical Trials”, to be held on October 31, 2019 at 08:30 a.m. to 5:00 p.m. ET in Silver Spring, Maryland, USA, with Webcast option available.





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).


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).


Candidaturas para painel de peritos da Comissão Europeia para dispositivos médicos e dispositivos de diagnóstico in vitro

Os novos regulamentos Europeus, relativos aos dispositivos médicos e aos dispositivos para diagnóstico in vitro, estabelecem a criação de painéis de peritos para apoiar a avaliação de determinados dispositivos de alto risco, prestando aconselhamento à Comissão Europeia, ao Medical Device Coordination Group (MDCG), aos Estados-membros, aos Organismos Notificados e aos fabricantes.


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 3.º trimestre de 2019, foi atualizada.

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