News Archive

PIC/S Concept Papers on the revision of EU-PIC/S GMP Annexes 4 & 5

11th November 2021

The PIC/S Working Group on Veterinary Medicinal Products (VMP), led by Grégory Verdier (France / ANSES), and the EMA GMP/GDP Inspectors Working Group have jointly developed two concept papers on the revision of Annex 4 (manufacture of veterinary medicinal products other than immunologicals) and Annex 5 (manufacture of immunological veterinary medicinal products) of the EU-PIC/S GMP Guide.

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WHO - International organisations, vaccine manufacturers take stock of COVID-19 vaccine roll out, share views for 2022

11th November 2021

International organisations, vaccine manufacturers take stock of COVID-19 vaccine roll out, share views for 2022

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EMA - Invitation to the 4th public stakeholder meeting on COVID-19 therapeutics and vaccines in the EU

4th November 2021

Invitation to the 4th public stakeholder meeting on COVID-19 therapeutics and vaccines in the EU

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MHRA - First oral antiviral for COVID-19, Lagevrio (molnupiravir), approved by MHRA

4th November 2021

The antiviral was found to be safe and effective following a stringent review of the available evidence.

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EMA - Generating high-quality evidence from registry-based studies

27th October 2021

EMA has published guidance to provide key methods and good regulatory practices to pharmaceutical organisations on the planning and conduct of registry-based studies.

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MHRA - launches public consultation on future of medical device regulation

27th October 2021

The Medicines and Healthcare products Regulatory Agency (MHRA) is inviting members of the public to provide their views on possible changes to the regulatory framework for medical devices in the United Kingdom (UK).

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MHRA - Upcoming Board Meeting

27th October 2021

The next MHRA Board meeting will take place on the 16th November. The general public can attend this virtual meeting.

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ICH - The ICH E8(R1) Guideline reaches Step 4 of the ICH Process

12th October 2021

The ICH E8(R1) Guideline on General considerations for Clinical Studies reached Step 4 of the ICH Process on 6 October 2021.

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EC - Good Lay Summary Practice Guidance

7th October 2021

This “Good Lay Summary Practice” (“GLSP”) provides recommendations on how to prepare, write, translate, and disseminate summaries of clinical trial results in lay language. This is a mandatory requirement laid out in Regulation (EU) No. 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use (“EU CTR”) and a transparency obligation to all trial participants and the interested public.

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EMA - CTIS Virtual Info Day

7th October 2021

The EMA will host a CTIS virtual information day in liaison with DIA on 26th October 2021 from 13:15 to 17:00 (CET). The aim of the event is to help future CTIS users prepare for submitting and managing clinical trial applications in CTIS after its go-live on 31 January 2022.

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