Consultation on the International Council for Harmonisation Guideline Q3E for Extractables and Leachables

All babies in the UK get the hepatitis B vaccine. It has a well-established safety record and ensures long-term protection against the virus.

List of Field Safety Notices from 11 to 15 August 2025.

Guidance on applying for a Marketing Authorisation for Decentralised Manufacture, including eligibility, process, and requirements.

The MHRA provides an update to previous guidance on the management of patients treated with the recalled Endologix Nellix EVAS System to reflect revised recommendations. All implanted patients in the UK with this device should be identified and appropriate action taken.

Summary of the latest safety advice for medicines and medical device users

Professor Henrietta Hughes reflects on how MHRA strategy must prioritise patient safety via listening to lived experiences, fostering collaboration & innovation.