Marketing authorisations granted in 2025.
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Safety Public Assessment Reports
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
MHRA seeks input on AI regulation at ‘pivotal moment’ for healthcare
National Commission is seeking evidence to shape regulation of AI in healthcare and support the UK’s ambition for a world-leading, AI-enabled NHS
Decision: Advertising Investigations: September 2025
Decisions made by the MHRA following investigations into complaints about advertising for licensed medicines.
MHRA and NICE receive £2 million from Wellcome to improve safety and effectiveness of digital mental health technologies
Additional funding will allow the MHRA and NICE to continue developing clear, proportionate guidance for digital mental health technologies, supporting safer, more effective tools for people across the UK.
First major overhaul of medical device regulation comes into force across Great Britain
New Post-Market Surveillance (PMS) regulations have taken effect across Great Britain, requiring medical device manufacturers to proactively monitor the safety and performance of their products once on the market.
Field Safety Notices: 8 to 12 September 2025
List of Field Safety Notices from 8 to 12 September 2025.