Medicines and Healthcare products Regulatory Agency (MHRA)

The UK Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency responsible for regulating medicines, medical devices, and blood components for transfusion in the United Kingdom. Operating under the Department of Health and Social Care, the MHRA’s task is to ensure that these products are safe, effective, and meet pertinent quality standards before they are marketed and used by the public.

The MHRA’s role includes the approval and monitoring of medicinal products, and market surveillance of medical devices. For medicines, it oversees clinical trials, evaluates safety data, and issues marketing authorizations. The agency also monitors adverse drug reactions and is to take action when safety concerns arise. Regarding medical devices, the MHRA aims at ensuring that devices comply with regulatory standards, conducting inspections, and post-market surveillance to track medical device safety and performance.

In addition to regulatory oversight, the MHRA provides guidance to manufacturers, healthcare professionals, and the public on safe use of and potential risks associated with healthcare products. It is also involved in setting standards for manufacturing and quality control.