Overview
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:
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.
From Wikipedia (CC BY-SA 4.0).