Medicines and Healthcare Products Regulatory Agency
|Executive agency overview|
|Formed||1 April 2003|
|Headquarters||London, United Kingdom
|Executive agency executives||
|Parent department||Department of Health|
The Medicines and Healthcare Products Regulatory Agency (MHRA) is an executive agency of the Department of Health in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably safe.
The Medicines and Healthcare Products Regulatory Agency 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 over 1,200 people.
The MHRA is divided into three main centres:
- MHRA Regulatory (the regulator for the pharmaceutical and medical devices industries)
- Clinical Practice Research Datalink
- National Institute for Biological Standards and Control
In 1999, the Medicines Control Agency (MCA) took over control of the General Practice Research Database (GPRD) from Office for National Statistics. Medicines Control Agency (MCA) and the Medical Devices Agency (MDA) merged in 2003 to form the Medicines and Healthcare Products Regulatory Agency (with a lower case "products" at that time). In April 2012, the GPRD was expanded and relaunched as the Clinical Practice Datalink (CPRD). In April 2013, the 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 the CPRD was formally declared a separate centre of the MHRA, too.
- Operate post-marketing surveillance for reporting, investigating and monitoring of adverse drug reactions to medicines and incidents with medical devices.
- Assessment and authorisation of medicinal products for sale and supply in 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.
MHRA hosts and supports a number of expert advisory bodies, including the Commission on Human Medicine which replaced the Committee on the Safety of Medicines in 2005, and the British Pharmacopoeia Commission.
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 is funded by the Department of Health 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 US Food and Drug Administration) have been criticised in the book Bad Pharma, and by Dr David Healy in evidence to the House of Commons Health Committee, for having undergone regulatory capture; advancing the interests of the drug companies rather than the interests of the public.
...the industry has shaped the rules of the regulators, funded their operations, and lobbied them constantly in a classic pattern of regulatory capture....
- Black triangle scheme
- European Medicines Agency (EMA)
- Food and Drug Administration (FDA)
- List of pharmacy organizations in the United Kingdom
- Regulation of therapeutic goods
- Yellow Card Scheme
- "About us". www.gov.uk. Medicines and Healthcare Products Regulatory Agency. Retrieved 13 March 2016.
- "Medicines and Healthcare products Regulatory Agency Expands". MHRA. 28 March 2013. Retrieved 4 April 2013.
- "How is the MHRA funded?". MHRA. Retrieved 18 September 2013.
- Flynn MP, Paul. "Early Day Motion 1197: MHRA". Session 2012-13. House of Commons. Retrieved 18 September 2013.
- "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. line feed character in
|work=at position 39 (help)
- 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.
- Light, Donald. "Rapid Response to Don't Blame it all on the Bogey". 2007. British Medical Journal (BMJ). Retrieved 16 August 2013.