The MHRA has received reports describing a positive bias in HbA1c results delivered by the Trinity Biotech Premier Hb9210 HbA1c analyser, which has resulted in patients being incorrectly diagnosed as pre-diabetic or diabetic.
List of Field Safety Notices from 14 to 18 July 2025.
Ensuring the seasonal flu vaccine is ready, safe and effective involves months of international planning, testing and collaboration
The MHRA is inviting members of the public to provide their views on proposed changes to the regulatory framework for medical devices.
The MHRA has now published the government’s response to its public consultation on future routes to market for medical devices – designed to modernise regulation
The Medicines and Healthcare products Regulatory Agency (MHRA) has published its 2024–25 Annual Report and Accounts, and accompanying Impact Report.
Annual Report of the Human Medicines Regulations 2012 Advisory Bodies – the Commission on Human Medicines (CHM) and the British Pharmacopoeia Commission.
MHRA annual report and accounts 2024 to 2025.
List of Field Safety Notices from 7 to 11 July 2025.
Performance data for MHRA key performance indicators (KPIs) and information on the expected timeline to complete a specific regulatory function.
We invite feedback on the operation and impact of the human medicines and medical devices legislation as part of a statutory review required under the Medicines and Medical Devices Act 2021.
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 18 July 2025, approved adrenaline (epinephrine) nasal spray (EURneffy) to be used for the emergency treatment of serious allergic reactions, known as anaphylaxis.
