News Archive

MHRA Blog - New Leadership and a focus on Software

24th February 2025

Rob Reid, 21 February 2025

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MHRA - Updates to PV Exceptions and Modifications Document

20th February 2025

Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK MAHs and the MHRA

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EMA - CTIS Newsflash 11th Feb 2025

19th February 2025

This regular CTIS newsflash provides key updates on CTIS and links to useful reference materials.

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EMA - Clinical Trials Highlights Feb 2025

19th February 2025

Updates on the ACT EU initiative, CTIS and the clinical trials landscape in the EU

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EMA - Human Medicines Highlights Feb 2025

19th February 2025

The newsletter for patients, consumers and healthcare professionals

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EMA - Regular procedure for scientific advice on certain high-risk medical devices

12th February 2025

Manufacturers can request advice on their medical device clinical development programme

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FDA - Institutional Review Board (IRB) Written Procedures

12th February 2025

Guidance for Institutions and IRBs OHRP's and FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance describes OHRP's and FDA's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.

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MHRA - Exceptions and modifications to the EU guidance on good pharmacovigilance practices

12th February 2025

This guidance clarifies the expectations on the application of the EU guidance on good pharmacovigilance practices (GVP) - guidance notes updated.

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MHRA - MHRA Real-World Evidence Scientific Dialogue Programme

12th February 2025

Link to Expression of Interest form added 10th Feb. 2025

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MHRA - Implementation of ICH E6(R3)

11th February 2025

Confirmation of when it is expected to come into force.

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