News Archive

MHRA - Medicines Pipeline data

14th August 2024

New Guidance Published

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MHRA - Pre-submission Advice & Support

14th August 2024

New Guidance Published

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VICH - Veterinary Scientific Guidance Updates

14th August 2024

Updates from 2024

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EMA - CTIS Simplification Force

13th August 2024

As part of the work of the CTIS Simplification Force, EMA are proposing some changes to the CTIS roles matrix.

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EMA - Guideline on good pharmacovigilance practices (GVP) Annex I - Definitions (Rev 5)

6th August 2024

Released 26th July 2024

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EMA - Real-world evidence framework to support EU regulatory decision-making

1st August 2024

2nd report on the experience gained with regulator-led studies from February 2023 to February 2024.

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MHRA - Drug Safety Update

1st August 2024

Volume 18, 1st August 2024

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HRA - Demographic Survey Report

31st July 2024

The HRA community were asked to complete a diversity and inclusion survey.  The results help build a picture of who HRA's members are, help them understand who isn’t part of their community, and help them to take action so that members better reflect the diversity of society.

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HMA/EMA - Multi-Stakeholder Workshop on AI

24th July 2024

5th November 2024

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EMA public launch event on the guideline on good pharmacovigilance practices Module XVI on risk minimisation measures and its Addendum II

22nd July 2024

The European Medicines Agency (EMA) is hosting an online event to launch the revised guideline on good pharmacovigilance practices (GVP) Module XVI and its Addendum II. The event will provide an overview of how stakeholder comments from the public consultation on these documents have been addressed. This will be followed by a questions and answers session for answering audience questions.

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