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News Archive
EMA - CTIS Newsflash 11th Feb 2025
19th February 2025This regular CTIS newsflash provides key updates on CTIS and links to useful reference materials.
EMA - Clinical Trials Highlights Feb 2025
19th February 2025Updates on the ACT EU initiative, CTIS and the clinical trials landscape in the EU
EMA - Human Medicines Highlights Feb 2025
19th February 2025The newsletter for patients, consumers and healthcare professionals
EMA - Regular procedure for scientific advice on certain high-risk medical devices
12th February 2025Manufacturers can request advice on their medical device clinical development programme
FDA - Institutional Review Board (IRB) Written Procedures
12th February 2025Guidance 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.
MHRA - Exceptions and modifications to the EU guidance on good pharmacovigilance practices
12th February 2025This guidance clarifies the expectations on the application of the EU guidance on good pharmacovigilance practices (GVP) - guidance notes updated.
MHRA - MHRA Real-World Evidence Scientific Dialogue Programme
12th February 2025Link to Expression of Interest form added 10th Feb. 2025
MHRA - Implementation of ICH E6(R3)
11th February 2025Confirmation of when it is expected to come into force.
MHRA - Digital mental health technology: qualification and classification Guidance
4th February 2025Released 3rd Feb 2025
HRA - Developing a New Strategy Blog
3rd February 2025Our 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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