The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care, that regulates medicines, medical devices and blood components for transfusion in the UK. The agency plays a central role in protecting public health by regulating products used in healthcare across the UK and has offices in London, Hertfordshire and Leeds. It also provides scientific advice to the life sciences sector and contributes to the development of regulatory policy and standards at national and international levels.
Responsibilities The MHRA's responsibilities are to:
ensure medicines, medical devices and blood components for transfusion meet applicable standards of safety, quality and efficacy (effectiveness) secure safe supply chain for medicines, medical devices and blood components promote international standardisation and harmonisation to assure the effectiveness and safety of biological medicines educate the UK public and healthcare professionals about the risks and benefits of medicines, medical devices and blood components, leading to safer and more effective use enable innovation and research and development that is beneficial to public health collaborate with partners in the UK and internationally to support its mission to enable the earliest access to safe medicines and medical devices and to protect public health.
Governance The MHRA operates as an executive agency of the Department of Health and Social Care. It is led by a chief executive, who is accountable to the Secretary of State for Health and Social Care. Lawrence Tallon assumed the role of chief executive in 2025, succeeding Dame June Raine who had held the post since 2019. The agency is governed by a board of directors and a chairperson. The current chair of the MHRA is Anthony Harnden. A number of committees and expert groups provide independent scientific and clinical advice on regulatory decisions.
History The MHRA was established in 2003 through the merger of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA). The creation of a single regulator was intended to streamline oversight of medicines and medical devices and strengthen the UK's ability to respond to emerging safety issues. Following the United Kingdom's withdrawal from the European Union, the MHRA assumed additional responsibilities that had previously been carried out through EU regulatory frameworks, including the independent licensing of medicines for the UK market.
Funding The MHRA is funded through a combination of grant-in-aid from the UK government and income generated from fees and charges levied on the pharmaceutical, medical device, and life sciences industries for regulatory services. These services include marketing authorisation applications, inspections, licensing, and scientific advice. The level of government funding and fee income is set annually as part of the UK government's spending review and budgetary process. The MHRA publishes details of its financial performance, including income, expenditure, and fee structures, in its annual report and accounts.
Notable interventions COVID-19 vaccine authorisation In December 2020, the MHRA became the first medicines regulator in the world to grant temporary authorisation for the Pfizer–BioNTech COVID-19 vaccine (BNT162b2), following a rolling review of clinical trial data on safety, quality, and efficacy. The decision enabled the rapid deployment of the vaccine across the United Kingdom. Approval of Casgevy (exagamglogene autotemcel) In 2023, the MHRA became the first regulatory authority globally to approve Casgevy (exagamglogene autotemcel), a CRISPR-based gene-editing therapy for the treatment of sickle cell disease and transfusion-dependent beta thalassaemia. Rare Disease therapies In 2025, the MHRA outlined proposals to reform the regulatory framework for rare disease treatments, aiming to reduce barriers to development and approval while maintaining high safety standards. The initiative focuses on improving evidence generation for small patient populations, strengthening post-market surveillance, and working with a Rare Disease Consortium of patients, academics, and industry to develop more flexible pathways for innovative and personalised therapies. Artificial Intelligence Commission The MHRA launched in September 2025 a national commission on the Regulation of AI in Healthcare, which is responsible for advising the MHRA on a world-leading framework for the regulation of "artificial intelligence" products. The Commission includes representation from clinicians, other regulators, and global AI experts. Decentralised manufacturing The UK was the first country in the world to introduce a tailored framework for the regulation of innovative products manufactured at or close to the location where a patient receives care. This means that medicines with a very short shelf life, and highly personalised medicines, can more easily be made in or near a hospital setting and can be supplied to patients safely and more quickly.
References
External links Official website National Institute for Biological Standards and Control (NIBSC) website Clinical Practice Research Datalink (CPRD) website
