News Archive

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

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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MHRA - Digital mental health technology: qualification and classification Guidance

4th February 2025

Released 3rd Feb 2025

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HRA - Developing a New Strategy Blog

3rd February 2025

Our current strategy was written to last three years, and now we’re planning a new strategy, starting in 2025, which will set out what we are going to do to deliver our mission over the next three years.

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