Medicines and Healthcare products Regulatory Agency

Medicines and Healthcare products Regulatory Agency

Executive agency overview
Formed	1 April 2003; 21 years ago (2003-04-01)
Preceding agencies	Medicines Control Agency Medical Devices Agency
Headquarters	10 South Colonnade, London E14 United Kingdom
Minister responsible	Karin Smyth, Minister of State for Health at the Department of Health and Social Care
Executive agency executives	June Raine, Chief Executive Anthony Harnden, Chair
Parent department	Department of Health and Social Care
Child agencies	MHRA Regulatory Clinical Practice Research Datalink National Institute for Biological Standards and Control
Website	www.gov.uk/mhra

The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably safe.

The MHRA was formed in 2003 with the merger of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA). In April 2013, it merged with the National Institute for Biological Standards and Control (NIBSC) and was rebranded, with the MHRA identity being used solely for the regulatory centre within the group. The agency employs more than 1,200 people in London, York and South Mimms, Hertfordshire.^[1]

The MHRA is divided into three main centres:^{[citation needed]}

• MHRA Regulatory – the regulator for the pharmaceutical and medical devices industries
• Clinical Practice Research Datalink – licences anonymised health care data to pharmaceutical companies, academics and other regulators for research
• National Institute for Biological Standards and Control – responsible for the standardisation and control of biological medicines

The MHRA has several independent advisory committees which provide the UK Government with information and guidance on the regulation of medicines and medical devices. There are currently eight such committees:^{[citation needed]}

• Advisory Board on the Registration of Homeopathic Products
• Herbal Medicines Advisory Committee
• The Review Panel
• Independent Scientific Advisory Committee for MHRA database research
• Medicines Industry Liaison Group
• Innovation Office
• Blood Consultative Committee
• Devices Expert Advisory Committee

In 1999, the Medicines Control Agency (MCA) took over control of the General Practice Research Database (GPRD) from the Office for National Statistics. The Medicines Control Agency (MCA) and the Medical Devices Agency (MDA) merged in 2003 to form MHRA. In April 2012, the GPRD was rebranded as the Clinical Practice Research Datalink (CPRD). In April 2013, MHRA merged with the National Institute for Biological Standards and Control (NIBSC) and was rebranded, with the MHRA identity being used for the parent organisation and one of the centres within the group. At the same time, CPRD was made a separate centre of the MHRA.^[2]

1. Operate post-marketing surveillance – in particular the Yellow Card Scheme – for reporting, investigating and monitoring of adverse drug reactions to medicines and incidents with medical devices.
2. Assess and authorise of medicinal products for sale and supply in the UK.
3. Oversee the Notified Bodies that ensure medical device manufacturers comply with regulatory requirements before putting devices on the market.
4. Operate a quality surveillance system to sample and test medicines to address quality defects and to monitor the safety and quality of unlicensed products.
5. Investigate internet sales and potential counterfeiting of medicines, and prosecute where necessary.
6. Regulate clinical trials of medicines and medical devices.
7. Monitor and ensure compliance with statutory obligations relating to medicines and medical devices.
8. Promote safe use of medicines and devices.
9. Manage the Clinical Practice Research Datalink and the British Pharmacopoeia.

The MHRA hosts and supports a number of expert advisory bodies, including the British Pharmacopoeia Commission, and the Commission on Human Medicine which replaced the Committee on the Safety of Medicines in 2005.^{[citation needed]}

The MHRA manages the Early Access to Medicines Scheme (EAMS), which was created in 2014 to allow access to medicines prior to market authorisation where there is a clear unmet medical need.

Prior to the UK's departure from the European Union in January 2021, the MHRA was part of the European system of approval. Under this system, national bodies can be the rapporteur or co-rapporteur for any given pharmaceutical application, taking on the bulk of the verification work on behalf of all members, while the documents are still sent to other members as and where requested.

From January 2021, the MHRA is instead a stand-alone body,^[3] although under the Northern Ireland Protocol the authorisation of medicines marketed in Northern Ireland continued to be the responsibility of the European Medicines Agency.^[4] However, as a result of the 2023 Windsor Framework, the MHRA is expected to once again deal with authorisation throughout the United Kingdom.^[5]

The MHRA is funded by the Department of Health and Social Care for the regulation of medical devices, whilst the costs of medicines regulation is met through fees from the pharmaceutical industry.^[6] This has led to suggestions by some MPs that the MHRA is too reliant on industry, and so not fully independent.^[7]

In 2017, the MHRA was awarded over £980,000 by the Bill & Melinda Gates Foundation to fund its work with the foundation and the World Health Organization on improving safety monitoring for new medicines in low and middle-income countries.^[8] In response to a Freedom of Information request, in 2022 the MHRA stated that approximately £3 million had been received from the Gates Foundation for a number of initiatives spanning several financial years.^[9]

June Raine has been the chief executive of the MHRA since 2019,^[10] succeeding Ian Hudson who had held the post since 2013.^[11]

The MHRA's strategy is set by a board which consists of a chairperson (appointed for a three-year term^[12] by the Secretary of State for the Department of Health and Social Care)^[13] and eight non-executive directors, together with the chief executive and chief operating officer.^[14] The current co-chairs are Amanda Calvert, Graham Cooke and Michael Whitehouse.^[15]

• 2003^[16] to December 2012^[17] – Sir Alasdair Breckenridge
• January 2013 to 2014 – Gordon Duff^[18]
• December 2014^[19] to 2020^[20] – Michael Rawlins (also chaired UK Biobank; previously chair of the National Institute for Health and Care Excellence)
• September 2020 to July 2023 – Stephen Lightfoot (also chaired Sussex Community NHS Foundation Trust)^[21]

On 2 December 2020, the MHRA became the first global medicines regulator to approve an RNA vaccine when it gave conditional and temporary authorization to supply for use of the Pfizer–BioNTech COVID-19 vaccine codenamed BNT162b2^[22][23][24] (later branded as Comirnaty).^[25][26] This approval enabled the start of the UK's COVID-19 vaccination programme. The regulator's public assessment report for the vaccine was published in 15 December.^[27]

The MHRA went on to give conditional and temporary authorization to supply of further vaccines: AZD1222 from Oxford University and AstraZeneca on 30 December,^[28] mRNA-1273 from Moderna on 8 January 2021,^[29] and a single-dose vaccine from Janssen on 28 May 2021.^[30] The approval of the Pfizer-BioNTech vaccine was extended to young people aged 12–15 in June 2021,^[31] 5–11 in December 2021,^[32] and from six months in December 2022.^[33]

The status of the Oxford / AstraZeneca vaccine was upgraded to conditional marketing authorisation on 24 June 2021.^[28] The MHRA confirmed in September 2021 that supplementary "booster" doses of these vaccines would be safe and effective, but stated that the Joint Committee on Vaccination and Immunisation had the task of advising if and when they should be used in this way.^[34] Later that month, the MHRA said the Moderna vaccine could also be given as a booster dose.^[35]

In August and September 2022, the MHRA approved the first bivalent COVID-19 booster vaccines.^[36][37]

In January 2021, the MHRA expressed concern to the UK government over plans to deploy lateral flow tests in schools in England, stating that they had not authorised daily use of the tests due to concerns that negative results may give false reassurance.^[38] The government suspended the scheme the following week, citing risks arising from high prevalence of the virus and higher rates of transmission of a new variant.^[39]

In July 2023, MHRA began a consultation to reclassify cough syrups containing codeine (an opiate) as prescription-only medicines, in response to a rise in recreational drug abuse cases since 2018. There were 277 serious and fatal reactions to medicines containing codeine in 2021, and 243 in 2022.^[40]

In 2005, the MHRA was criticised by the House of Commons Health Committee for, among other things, lacking transparency,^[41] and for inadequately checking drug licensing data.^[42]

The MHRA and the US Food and Drug Administration were criticised in the 2012 book Bad Pharma,^[43] and in 2004 by David Healy in evidence to the House of Commons Health Committee,^[44] for having undergone regulatory capture, i.e. advancing the interests of the drug companies rather than the interests of the public.

The Cumberlege Report, also known as the Independent Medicines and Medical Devices Safety Review, is a comprehensive report commissioned by the UK government to investigate the harm caused by certain medical treatments and devices. Released in 2020, the report highlighted the suffering of thousands of patients who experienced complications from treatments such as pelvic mesh implants, sodium valproate, and Primodos. It criticized MHRA's failure to adequately respond to these issues, calling for improved patient safety measures, better regulation of medical devices, and increased support for those affected.^[45]

The COVID Response & Recovery APPG wrote to Stephen Brine, chairperson of the Health Select Committee, in October 2023 raising concerns about serious failures by MHRA and demanding an urgent investigation.^[46]

• Black triangle scheme
• List of pharmacy organisations in the United Kingdom
• European Medicines Agency
• Food and Drug Administration (United States)
• Regulation of therapeutic goods

• Official website
• National Institute for Biological Standards and Control (NIBSC) website
• Clinical Practice Research Datalink (CPRD) website