{{Short description|Medicine regulation agency in the UK}} {{Distinguish|text = the [[Modern Humanities Research Association]], also abbreviated ''MHRA''}} {{Use British English|date=June 2013}} {{Use dmy dates|date=August 2022}} {{Infobox government agency | agency_name = Medicines and Healthcare products Regulatory Agency | type = Executive agency | seal = | chief6_position = | chief7_name = | chief7_position = | chief8_name = | chief8_position = | chief9_name = | chief9_position = | parent_department = [[Department of Health and Social Care]] | logo = UK Medicines & Healthcare Products Regulatory Agency logo.svg | logo_width = | logo_caption = | picture = | picture_width = | picture_caption = | formed = {{Start date and age|df=yes|2003|04|01}} | preceding1 = Medicines Control Agency | preceding2 = Medical Devices Agency | jurisdiction = | headquarters = 10 South Colonnade, London {{postcode|E|14}}<br />United Kingdom | coordinates = | motto = | employees = | budget = | minister2_name = | minister2_pfo = <!-- (etc.) --> | deputyminister1_name = | deputyminister1_pfo = | deputyminister2_name = | deputyminister2_pfo = <!-- (etc.) --> | chief1_name = Lawrence Tallon | chief1_position = Chief Executive | chief2_name = Anthony Harnden | chief2_position = Chair | chief3_name = | chief3_position = | chief4_name = | chief4_position = | chief5_name = | chief5_position = | chief6_name = | keydocument1 = | website = {{Official URL}} | footnotes = | map = | map_width = | map_caption = }}
The '''Medicines and Healthcare products Regulatory Agency''' 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 [[Health in the United Kingdom|public health]] by regulating products used in [[Healthcare in the United Kingdom|healthcare across the UK]] and has offices in London, [[Hertfordshire]] and [[Leeds]].<ref name="MHRA launches new digital hub in Leeds to drive innovation and regional growth">{{cite web |title=MHRA launches new digital hub in Leeds to drive innovation and regional growth |url=https://www.gov.uk/government/news/mhra-launches-new-digital-hub-in-leeds-to-drive-innovation-and-regional-growth |website=GOV.UK|date=5 June 2025|access-date=18 March 2026|publisher=MHRA}}</ref> 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:<ref name="MHRA - About US">{{cite web |title=About Us |url=https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency/about |website=MHRA}}</ref>
* 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.<ref name="MHRA launches new digital hub in Leeds to drive innovation and regional growth" /> It is led by a chief executive, who is accountable to the Secretary of State for Health and Social Care.<ref name="Framework agreement between DHSC and the Medicines and Healthcare products Regulatory Agency">{{cite web |title=Framework agreement between DHSC and the Medicines and Healthcare products Regulatory Agency |url=https://www.gov.uk/government/publications/dh-and-mhra-framework-agreement/framework-agreement-between-dhsc-and-the-medicines-and-healthcare-products-regulatory-agency |website=GOV.UK - DHSC}}</ref> Lawrence Tallon assumed the role of chief executive in 2025, succeeding Dame [[June Raine]] who had held the post since 2019.<ref name="New Chief Executive appointed at MHRA">{{cite web |title=New Chief Executive appointed at MHRA |url=https://www.gov.uk/government/news/new-chief-executive-appointed-at-mhra |website=GOV.UK|date=3 March 2025|access-date=18 March 2026}}</ref>
The agency is governed by a board of directors and a chairperson.<ref name="MHRA - About US" /> The current chair of the MHRA is [[Anthony Harnden]].<ref name="New Chair of the MHRA">{{cite web |title=New Chair of the MHRA |url=https://www.gov.uk/government/news/new-chair-of-the-mhra |website=GOV.UK - MHRA}}</ref>
A number of committees and expert groups provide independent scientific and clinical advice on regulatory decisions.<ref name="CHM membership">{{cite web |title=CHM membership |url=https://www.gov.uk/government/organisations/commission-on-human-medicines/about/membership |website=GOV.UK - MHRA}}</ref>
==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.<ref name="UK withdrawal from the EU on 31 January 2020">{{cite web |title=UK withdrawal from the EU on 31 January 2020 |url=https://www.ema.europa.eu/en/news/uk-withdrawal-eu-31-january-2020 |website=EMA}}</ref>
==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.<ref name="Framework agreement between DHSC and the Medicines and Healthcare products Regulatory Agency" />
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.<ref name="MHRA Annual Report and Accounts 2024 to 2025">{{cite web |title=MHRA Annual Report and Accounts 2024 to 2025 |url=https://www.gov.uk/government/publications/medicines-and-healthcare-products-regulatory-agency-annual-report-and-accounts-2024-to-2025 |website=GOV.UK - MHRA}}</ref>
== 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.<ref name="Covid-19: Pfizer/BioNTech vaccine judged safe for use in UK">{{cite news |title=Covid-19: Pfizer/BioNTech vaccine judged safe for use in UK |url=https://www.bbc.co.uk/news/health-55145696 |publisher=BBC News |date=2 December 2020}}</ref>
'''Approval of Casgevy (exagamglogene autotemcel)'''
In 2023, the MHRA became the first regulatory authority globally to approve [[Casgevy]] (exagamglogene autotemcel), a [[CRISPR]]-based [[Genome editing|gene-editing]] therapy for the treatment of [[sickle cell disease]] and transfusion-dependent [[Beta thalassemia|beta thalassaemia]].<ref name="UK first to approve CRISPR treatment for diseases: what you need to know">{{cite news |title=UK first to approve CRISPR treatment for diseases: what you need to know |url=https://www.nature.com/articles/d41586-023-03590-6 |publisher=Nature |date=16 November 2023}}</ref>
'''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.<ref name="Major change for rare disease therapies on way">{{cite web |title=Major change for rare disease therapies on way |url=https://www.gov.uk/government/news/major-change-for-rare-disease-treatments-on-way-signals-mhra |website=GOV.UK - MHRA|date=2 November 2025|publisher=MHRA}}</ref>
'''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.<ref name="UK Seeks AI Rules to Spur Health-Care Overhaul, Protect Patients">{{cite news |title=UK Seeks AI Rules to Spur Health-Care Overhaul, Protect Patients |url=https://www.bloomberg.com/news/articles/2025-09-26/ai-and-health-care-uk-grapples-with-regulation-while-seeking-investment |publisher=Bloomberg |date=26 September 2025}}</ref>
'''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.<ref name="MHRA publishes ‘world first’ decentralised manufacturing guidance">{{cite news |title=MHRA publishes 'world first' decentralised manufacturing guidance |url=https://pharmaceutical-journal.com/article/news/mhra-publishes-world-first-decentralised-manufacturing-guidance |publisher=The Pharmaceutical Journal |date=13 June 2025}}</ref>
==References== {{reflist}}
==External links== * {{Official website}} * [https://www.nibsc.org/ National Institute for Biological Standards and Control (NIBSC) website] * [https://cprd.com/home/ Clinical Practice Research Datalink (CPRD) website]
{{Department of Health (United Kingdom)}} {{Pharmaceutical industry in the United Kingdom}} {{Authority control}}
[[Category:2003 establishments in the United Kingdom]] [[Category:Canary Wharf]] [[Category:Department of Health and Social Care]] [[Category:Executive agencies of the United Kingdom government]] [[Category:Health in the London Borough of Tower Hamlets]] [[Category:Pharmacy organisations in the United Kingdom]] [[Category:Medical regulation in the United Kingdom]] [[Category:National agencies for drug regulation]] [[Category:Organisations based in the London Borough of Tower Hamlets]] [[Category:Organizations established in 2003]] [[Category:Regulators of biotechnology products]] [[Category:Regulators of the United Kingdom]] [[Category:Regulation of medical devices]]