As with all clinical trials, the MHRA’s top priority is the safety and wellbeing of the trial participants.
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MHRA updates product information regarding the very rare risk of non-arteritic anterior ischemic optic neuropathy (NAION) in patients taking semaglutide.
MHRA calls on public to report side effects and suspected fakes during #MedSafetyWeek
The tenth annual #MedSafetyWeek brings together more than 130 medicines regulators and health organisations across 117 countries to encourage people to report suspected side effects from medicines and device incidents.
Find product information about medicines
How to get information including patient information leaflets (PILs), details on how the medicine can be used (SmPCs) and scientific reports (PARs).
Guidance: AI Airlock Sandbox Pilot Programme Report
The MHRA’s AI Airlock pilot phase ran between April 2024 and March 2025. This report does not constitute formal MHRA guidance.
Trinity Biotech Premier Hb9210™ HbA1c Analyser: Risk of Positive Bias and Updates to Instructions for Use (IFU), including use as a diagnostic aid in diabetes mellitus (DSI/2025/003)
The MHRA has received reports describing a positive bias in HbA1c results delivered by the Trinity Biotech Premier Hb9210 HbA1c analyser, which has resulted in patients being incorrectly diagnosed as pre-diabetic or diabetic.
