Guidance on the collection, verification, and reporting of safety events in clinical trials of an investigational medicinal product.
Similar Posts
Corporate report: Human Medicines Regulations 2012 Advisory Bodies Annual Report 2024
Annual Report of the Human Medicines Regulations 2012 Advisory Bodies – the Commission on Human Medicines (CHM) and the British Pharmacopoeia Commission.
MHRA Takes Over Chair of International Access Consortium for 2026
The Access Consortium — comprising regulatory authorities from the UK, Australia, Canada, Singapore and Switzerland — works together to streamline regulatory processes, support innovation and improve global public health outcomes.
Common specification requirements for in vitro diagnostic devices
MHRA seeks views on possible amendments to the Medical Devices Regulations 2002 to include common specification requirements for manufacturers of IVD devices.
Updated guidance on the management of the recalled Endologix Nellix EndoVascular Aneurysm Sealing (EVAS) System (DSI/2025/004)
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.
MHRA Safety Roundup: May 2025
Summary of the latest safety advice for medicines and medical device users
Register medical devices to place on the market
How to register your medical devices with the MHRA for the markets in Great Britain and Northern Ireland.
