News Archive

MHRA - Performance Metrics Published

16th August 2024

MHRA performance metrics for clinical trials and established medicines assessment.

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EMA - Veterinary Scientific Guidance Update - Adopted and Draft Guidance

14th August 2024

New adopted and draft guidelines relating to Veterinary Products

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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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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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