List of Field Safety Notices for 22-26 December 2025
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Clinical investigations for medical devices
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Corporate report: MHRA Corporate Plan: 2023 to 2026 and Business Plan: 2025 to 2026
These reports outline the MHRA’s Corporate and Business Plans, detailing the agency’s strategic direction over the next three years.
Decision: Marketing authorisations Granted in 2026
Marketing authorisations Granted in 2026.
MHRA approves inavolisib for the treatment of breast cancer
The MHRA has today, 26 November 2025, approved inavolisib (Itovebi) for the treatment of adults with a type of breast cancer called HR-positive
Decision: Advertising Investigations: October 2025
Decisions made by the MHRA following investigations into complaints about advertising for licensed medicines.
Improving Information Supplied with Gabapentinoids (Pregabalin/Gabapentin), Benzodiazepines and Z-Drugs
The MHRA has reviewed the warnings regarding addiction, dependence, withdrawal, and
tolerance for gabapentin, pregabalin, benzodiazepines, and z-drugs. The findings (detailed in the Public Assessment Report) were that it was necessary to strengthen these warnings in the product information and on packaging to better inform healthcare professionals and patients of these known risks.