medicines and healthcare products regulatory agency 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. medicines and healthcare products regulatory agencyexecutive agency overviewformed1 april 2003 (2003-04-01)preceding agenciesmedicines control agencymedical devices agencyheadquarters10 south colonnade, london e14united kingdomminister responsiblewill quince, minister of state for health and secondary care at the department of health and social careexecutive agency executivesjune raine cbe, chief executivestephen lightfoot, chairjon fundrey, chief operating officerparent departmentdepartment of health and social carechild agenciesmhra regulatoryclinical practice research datalinknational institute for biological standards and controlwebsitewww.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency 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: 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 – 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 (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 – 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. 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 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 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. 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 on improving safety monitoring for new medicines in low and middle-income countries. in response to a freedom of information request, in 2022 the mhra stated that approximately £3 million had been received from the gates foundation for a number of initiatives spanning several financial years. key people june raine has been the chief executive of the mhra since 2019, succeeding 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