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.
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.
Structure.
The MHRA is divided into three main centres:
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:
History.
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.
Roles.
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.
European Union.
As part of the European system of approval, the 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.
On completion of the UK's departure from the European Union in January 2021, the MHRA becomes a stand-alone body.
Funding.
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.
Key people.
Dr June Raine has been the chief executive of the MHRA since 2019, succeeding Dr Ian Hudson who had held the post since 2013.
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.
Notable assessments and interventions.
COVID-19 vaccines.
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, and mRNA-1273 from Moderna on 8 January 2021.
COVID-19 tests.
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.
Criticism.
In 2005, the MHRA was criticised by the House of Commons Health Committee for, among other things, lacking transparency, and for inadequately checking drug licensing data.
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.
The 2016 reclassification of CBD oil and other hemp products as a medicine has been criticized as cruel and disproportionate to those using them.