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Clinical trials for medicines: manage your authorisation, report safety issues
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
MHRA launches Route B notification pilot as part of clinical trials regulations rollout
The pilot will help sponsors prepare for a new substantial modifications process under upcoming regulations, with responses delivered within 14 days.
Field Safety Notices: 10 to 14 November 2025
List of Field Safety Notices from 10 to 14 November 2025.
Decision: Suspended and revoked licences and registrations for manufacturers and wholesalers of medicines and ingredients
Public list of companies in the UK who have had their licence/registration to manufacture or wholesale medicines/ingredients revoked or suspended.
Device specific vigilance guidance: Cardiac Implantable Electronic Devices (CIEDs)
Guidance for manufacturers of cardiac implantable electronic devices and their leads. It outlines specific scenarios that should be considered when determining if an incident is reportable.
Decision: Advertising Investigations: August 2025
Decisions made by the MHRA following investigations into complaints about advertising for licensed medicines.