Medicines and Healthcare products Regulatory Agency
|Executive agency overview|
|Formed||1 April 2003|
|Headquarters||10 South Colonnade, London E14|
|Executive agency executives|
|Parent department||Department of Health and Social Care|
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.
The MHRA is divided into three main centres:
- MHRA Regulatory – the regulator for the pharmaceutical and medical devices industries
- Clinical Practice Research Datalink – oversees clinical primary care data 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:
- 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 expanded and relaunched 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.
- 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.
- Assess and authorise of medicinal products for sale and supply in the UK.
- Oversee the Notified Bodies that ensure medical device manufacturers comply with regulatory requirements before putting devices on the market.
- Operate a quality surveillance system to sample and test medicines to address quality defects and to monitor the safety and quality of unlicensed products.
- Investigate internet sales and potential counterfeiting of medicines, and prosecute where necessary.
- Regulate clinical trials of medicines and medical devices.
- Monitor and ensure compliance with statutory obligations relating to medicines and medical devices.
- Promote safe use of medicines and devices.
- 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.
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. However, under the Northern Ireland Protocol the authorisation of medicines marketed in Northern Ireland continues to be the responsibility of the European Medicines Agency.
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. This has led to suggestions by some MPs that the MHRA is too reliant on industry, and so not fully independent.
The MHRA's strategy is set by a board which consists of a chairperson (appointed for a three-year term by the Secretary of State for the Department of Health and Social Care) and eight non-executive directors, together with the chief executive and chief operating officer. The chair since September 2020 is Stephen Lightfoot, who is also chair of Sussex Community NHS Foundation Trust and non-executive chair of Sussex Primary Care Limited. Sir Michael Rawlins was the chair from 2014 to 2020.
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 (later branded as Comirnaty). 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.
The MHRA went on to give conditional and temporary authorization to supply of further vaccines: AZD1222 from Oxford University and AstraZeneca on 30 December, mRNA-1273 from Moderna on 8 January 2021, and a single-dose vaccine from Janssen on 28 May 2021. The approval of the Pfizer-BioNTech vaccine was extended to 12 to 15-year-olds on 4 June 2021.
The status of the Oxford / AstraZeneca vaccine was upgraded to conditional marketing authorisation on 24 June 2021. 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. Later that month, the MHRA said the Moderna vaccine could also be given as a booster dose.
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. 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.
The MHRA and the US Food and Drug Administration were criticised in the 2012 book Bad Pharma, and in 2004 by David Healy in evidence to the House of Commons Health Committee, for having undergone regulatory capture, i.e. advancing the interests of the drug companies rather than the interests of the public.
- Black triangle scheme
- List of pharmacy organisations in the United Kingdom
- European Medicines Agency
- Food and Drug Administration (United States)
- Regulation of therapeutic goods
- "About us". www.gov.uk. Medicines and Healthcare products Regulatory Agency. Retrieved 20 November 2020.
- "Medicines and Healthcare products Regulatory Agency Expands". MHRA. 28 March 2013. Archived from the original on 11 April 2013. Retrieved 4 April 2013.
- "MHRA post-transition period information". GOV.UK. 1 September 2020. Retrieved 2 December 2020.
- "SPCs and the Northern Ireland Protocol". GOV.UK. Intellectual Property Office. 1 June 2021. Retrieved 26 June 2021.
- "How is the MHRA funded?". MHRA. Archived from the original on 4 June 2014. Retrieved 18 September 2013.
- Flynn MP, Paul. "Early Day Motion 1197: MHRA". Session 2012-13. House of Commons. Retrieved 18 September 2013.
- "June Raine". GOV.UK. Retrieved 2 December 2020.
- "Dr Ian Hudson". GOV.UK. Retrieved 2 December 2020.
- Dunton, Jim (25 June 2020). "Department issues final call for candidates to be next MHRA chair". Civil Service World. Retrieved 2 December 2020.
- "Stephen Lightfoot". GOV.UK. Retrieved 2 December 2020.
- "Our governance". GOV.UK. Medicines & Healthcare products Regulatory Agency. Retrieved 2 December 2020.
- "Medicines & Healthcare products Regulatory Agency – Chair". GOV.UK. Cabinet Office. 7 August 2017. Retrieved 15 December 2020.
- "UK medicines regulator gives approval for first UK COVID-19 vaccine". GOV.UK. Retrieved 2 December 2020.
- Boseley, Sarah; Halliday, Josh (2 December 2020). "UK approves Pfizer/BioNTech Covid vaccine for rollout next week". The Guardian. Retrieved 2 December 2020.
- "Conditions of Authorisation for Pfizer/BioNTech COVID-19 vaccine". GOV.UK. MHRA. 15 December 2020. Retrieved 16 December 2020.
- "Comirnaty EPAR". European Medicines Agency (EMA). Retrieved 16 January 2021.
- "Comirnaty Trade mark number UK00003531641". Intellectual Property Office. 9 September 2020. Retrieved 16 January 2021.
- "Public Assessment Report for Pfizer/BioNTech COVID-19 vaccine" (PDF). MHRA. 11 December 2020. Retrieved 16 December 2020.
- "Regulatory approval of COVID-19 Vaccine AstraZeneca". GOV.UK. MHRA. 25 June 2021. Retrieved 26 June 2021.
- "Regulatory approval of COVID-19 Vaccine Moderna". GOV.UK. 8 January 2021. Retrieved 9 January 2021.
- "Regulatory approval of COVID-19 Vaccine Janssen". GOV.UK. 28 May 2021. Retrieved 28 June 2021.
- "The MHRA concludes positive safety profile for Pfizer/BioNTech vaccine in 12- to 15-year-olds". GOV.UK. 4 June 2021. Retrieved 2 October 2021.
- "MHRA statement on booster doses of Pfizer and AstraZeneca COVID-19 vaccines". GOV.UK. 9 September 2021. Retrieved 10 September 2021.
- "MHRA statement on COVID-19 booster vaccines". GOV.UK. 14 September 2021. Retrieved 15 September 2021.
- Halliday, Josh (14 January 2021). "Regulator refuses to approve mass daily Covid testing at English schools". The Guardian. ISSN 0261-3077. Retrieved 15 January 2021.
- Grafton-Green, Patrick (20 January 2021). "Daily Covid testing in schools paused amid emergence of new variant". LBC. Retrieved 21 January 2021.
- "The Influence of the Pharmaceutical Industry, Fourth Report of Session 2004–05, Volume I" (PDF). Page 5: "Greater transparency is also fundamental to the medicines regulatory system. There has to be better public access to materials considered by the MHRA prior to licensing". House of Commons Health Committee. Retrieved 16 August 2013.
- "The Influence of the Pharmaceutical Industry, Fourth Report of Session 2004–05, Volume I" (PDF). Page 4: "the Medicines and Healthcare Products Regulatory Agency (MHRA), has failed to adequately scrutinise licensing data and its post-marketing surveillance is inadequate. ". House of Commons Health Committee. Retrieved 16 August 2013.
- Goldacre, Ben (2012). Bad pharma : how drug companies mislead doctors and harm patients. London: Fourth Estate. ISBN 978-0-00-735074-2.
- Health Committee: Evidence. House of Commons Health Committee. 2004. p. 98. ISBN 9780215024572.
- "Cannabis-based products 'are medicine'". BBC News. 11 October 2016. Retrieved 23 July 2019.