GovWire

Decisions made by the MHRA following investigations into complaints about advertising for licensed medicines.

A programme to help decision-making across the lifecycle of products, benefitting both regulatory and health technology assessment (HTA) evaluations.

This guidance clarifies the expectations on the application of the EU guidance on good pharmacovigilance practices (GVP)

Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.

Scientific advice queries on nanomedicines have increased in recent years, particularly on lipid nanoparticles.

CNX Therapeutics is recalling the batches listed in this notification as a precautionary measure due to a small number of packs that contain an additional tablet of Nitrofurantoin. The registered product is a capsule containing powder and two yellow tablets.

The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 4 February 2025, approved the vaccine chikungunya vaccine (live) (brand name IXCHIQ) to protect adults against chikungunya disease, caused by the chikungunya virus (CHIKV).

List of Field Safety Notices from 27 to 31 January 2025.

Parallel import licences granted in 2025.

Marketing authorisations granted in 2025.

Information for manufacturers, healthcare professionals, researchers and patients on software as a medical device (SaMD) and AI as a medical device (AIaMD).

New guidance helps manufacturers navigate medical device regulations and protect users of digital mental health technologies.

Helping manufacturers define the characteristics of their devices and determine the appropriate regulatory qualification and classification.

Department of Health and Social Care and MHRA register of electronic export certificates (human).

Find out which COVID-19 test products have been approved.

The draft MHRA guidance aims to clarify and streamline pathways for bringing these therapies through to patients, without compromising on robust safety principles

We are seeking feedback on our new draft guideline on individualised mRNA cancer immunotherapies, a new type of cancer treatment being tested in clinical trials. This will help us to clarify and streamline pathways for bringing these therapies through to patients, without compromising on robust safety principles.

List of manufacturers and their medical devices granted an exemption by MHRA. The list also includes manufacturers whose exemption expired or was cancelled.

What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.

The New Active Substance Work Sharing Initiative (NASWSI) has successfully approved several medicines through this international collaboration and continues to foster cooperation and strong relationships between its Access partners. The Biosimilar Work Sharing Initiative (BSWSI) builds on this success.

A summary of the types of scientific advice available at the?MHRA, the process for getting advice and the fees involved.

Supplementary information on the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.

The New Active Substance Work Sharing Initiative (NASWSI) has successfully approved several medicines through this international collaboration and continues to foster cooperation and strong relationships between its Access partners. The Biosimilar Work Sharing Initiative (BSWSI) builds on this success.

List of manufacturers and their medical devices granted an exemption by MHRA. The list also includes manufacturers whose exemption expired or was cancelled.

Bristol Laboratories Limited is recalling the batches specified in the table as a precautionary measure due to possible microbial contamination.

It is the only example globally of an end-to-end access pathway, where a medicine developer can work collaboratively with the national health system, the regulator, and health technology assessment bodies from the early stages of clinical development.

The Innovative Licensing and Access Pathway (ILAP) is focussed on getting the most transformative new medicines, to patients in the UK health system more quickly.

List of Field Safety Notices from 23 to 27 December 2024