The MHRA has conducted an assessment following reports of osteolysis and early device failure in the literature and is issuing new monitoring requirements for patients implanted with the M6-C artificial cervical disc.
This privacy notice describes how we collect and use your personal information, in accordance with the Data Protection Act and the General Data Protection Regulation.
The MHRA is now setting out the next phase of reforms for 2026, aimed at helping patients access new cutting-edge treatments more quickly and boosting the UK’s competitiveness for global clinical research.
Guidance on the deadlines for initial and response submissions.
Decisions made by the MHRA following investigations into complaints about advertising for licensed medicines.
Public Assessment Report on improving information regarding addiction, dependence, withdrawal, and tolerance for gabapentin, pregabalin, 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.
As with any medicine, the MHRA will keep the safety and effectiveness of Nirogacestat hydrobromide under close review.
List of Field Safety Notices from 29 December 2025 to 2 January 2026.
In this new role, Professor George will lead the Agency’s science strategy and will oversee the MHRA’s scientific, research and innovation activities.
As with any medicine, the MHRA will keep the safety and effectiveness of zapomeran under close review.
Guidance for Marketing Authorisation (MA) applicants on providing consent to share operational information during the MA application process.
