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
medicine
Medicine is the science and practice of caring for a patient, managing the diagnosis, prognosis, prevention, treatment, palliation of their injury or disease, and promoting their health. Medicine encompasses a variety of health care pr ...
s and
medical device
A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assura ...
s 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
The National Institute for Biological Standards and Control (NIBSC) is a government agency that works in the field of biological standardisation and is part of the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA). It ...
(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:
* 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
The National Institute for Biological Standards and Control (NIBSC) is a government agency that works in the field of biological standardisation and is part of the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA). It ...
– 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
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 rebranded as the Clinical Practice Research Datalink (CPRD). In April 2013, MHRA merged with the
National Institute for Biological Standards and Control
The National Institute for Biological Standards and Control (NIBSC) is a government agency that works in the field of biological standardisation and is part of the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA). It ...
(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
# Operate
post-marketing surveillance Postmarketing surveillance (PMS), also known as post market surveillance, is the practice of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market and is an important part of the science of pharmac ...
– in particular the
Yellow Card Scheme
The Yellow Card Scheme is the United Kingdom's system for collecting information on suspected adverse drug reactions (ADRs) to medicines. The scheme allows the safety of the medicines and vaccines that are on the market to be monitored.
History ...
– 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.
European Union
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
Northern Ireland ( ga, Tuaisceart Éireann ; sco, label=Ulster Scots dialect, Ulster-Scots, Norlin Airlann) is a part of the United Kingdom, situated in the north-east of the island of Ireland, that is #Descriptions, variously described as ...
continues to be the responsibility of the
European Medicines Agency.
Funding
The MHRA is funded by the
Department of Health and Social Care for the regulation of
medical device
A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assura ...
s, 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.
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
The World Health Organization (WHO) is a specialized agency of the United Nations responsible for international public health. The WHO Constitution states its main objective as "the attainment by all peoples of the highest possible level o ...
on improving safety monitoring for new medicines in low and middle-income countries. In response to a
Freedom of Information
Freedom of information is freedom of a person or people to publish and consume information. Access to information is the ability for an individual to seek, receive and impart information effectively. This sometimes includes "scientific, indigen ...
request, in 2022 the MHRA stated that approximately £3million had been received from the Gates Foundation for a number of initiatives spanning several financial years.
Key people
Dr
June Raine
Dame June Munro Raine (' Harris; born 1952), is a British pharmacologist who is currently serving as the Chief Executive of the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom. Raine spent much of her career in ...
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.
Covid-19 interventions
On 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,
mRNA-1273 from
Moderna
Moderna, Inc. ( ) is an American pharmaceutical and biotechnology company based in Cambridge, Massachusetts that focuses on RNA therapeutics, primarily mRNA vaccines. These vaccines use a copy of a molecule called messenger RNA (mRNA) to ...
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 young people aged 12–15 in June 2021, 5–11 in December 2021, and from six months in December 2022.
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 August and September 2022, the MHRA approved the first bivalent COVID-19 booster vaccines.
On tests
In January 2021, the MHRA expressed concern to the UK government over plans to deploy
lateral flow test
A lateral flow test (LFT), is an assay also known as a lateral flow device (LFD), lateral flow immunochromatographic assay, or rapid test. It is a simple device intended to detect the presence of a target substance in a liquid sample without the ...
s 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
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...
were criticised in the 2012 book ''
Bad Pharma
''Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients'' is a book by the British physician and academic Ben Goldacre about the pharmaceutical industry, its relationship with the medical profession, and the extent to which it control ...
'', and in 2004 by
David Healy in evidence to the House of Commons Health Committee,
for having undergone
regulatory capture
In politics, regulatory capture (also agency capture and client politics) is a form of corruption of authority that occurs when a political entity, policymaker, or regulator is co-opted to serve the commercial, ideological, or political interests ...
, 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.
See also
*
Black triangle scheme
*
List of pharmacy organisations in the United Kingdom
*
European Medicines Agency
*
Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...
(United States)
*
Regulation of therapeutic goods
References
External links
*
National Institute for Biological Standards and Control (NIBSC) websiteClinical Practice Research Datalink (CPRD) website
{{Authority control
2003 establishments in the United Kingdom
Canary Wharf
Department of Health and Social Care
Executive agencies of the United Kingdom government
Health in the London Borough of Tower Hamlets
Pharmacy organisations in the United Kingdom
Medical regulation in the United Kingdom
National agencies for drug regulation
Organisations based in the London Borough of Tower Hamlets
Organizations established in 2003
Regulators of biotechnology products
Regulators of the United Kingdom