Medicines and Healthcare products Regulatory Agency
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.
|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 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 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.
As part of the European system of approval, MHRA or other 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.
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.
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 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.
- "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.
- "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.
- "Government asks regulator to approve supply of Oxford/AstraZeneca vaccine". GOV.UK. Department of Health and Social Care. 27 October 2020. Retrieved 28 November 2020.
- "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.