Medicines and Healthcare products Regulatory Agency (MHRA)

What is the UK MHRA? The Medicines and Healthcare products Regulatory Agency (MHRA) serves as the United Kingdom’s executive regulatory authority for medicines, medical devices, and blood components for transfusion. Operating within the Department of Health and Social Care, it was formed in 2003 through the merger of the Medicines Control Agency and the Medical Devices Agency, later absorbing the National Institute for Biological Standards and Control in 2013. Its mandate is to ensure health products across the UK meet required standards of safety, quality, and efficacy. What does the MHRA do? The MHRA executes comprehensive oversight of regulated health products across their entire life cycle. This includes pre-market authorization for medicines, oversight of medical devices via conformity assessment bodies, and rigorous enforcement of compliance and market standards. The agency monitors product safety through mechanisms like the Yellow Card Scheme for adverse event reporting, and acts against counterfeit or unlicensed therapeutic goods. It licenses clinical trials and engages in scientific policy guidance to encourage innovation and protect public health.