The MHRA

The Medicines and Healthcare Regulatory Agency regulates all medicines supplied in the UK as the Market Competent Authority (MCA).

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

MHRA and the manufacture and supply of medicines

MHRA decides whether medicines should be granted Marketing Authorisations and whether these can be varied as information about the medicines develop.

MHRA also carries out a number of regulatory activities before and after a licence is granted. These include:

Inspecting facilities that manufacture, distribute and test medicines to ensure they comply with Good Manufacturing Practice and Good Laboratory Practice (both national and international standards).

Approving UK-based clinical trials and inspect them to ensure they comply with Good Clinical Practice standards.

Regulating the importation of licensed medicines to the UK from other EU countries.

Monitoring the safety of medicines while on the market, for example by actively assessing Yellow Card reports and Product Defect Reports (see DMRC and VMD).

Unlicensed medicines.

For unlicensed medicines, the MHRA:

• Regulate the supply of unlicensed medicines into the UK, for example as “specials”.

• Carry out enforcement activities to prevent the illegal supply of unlicensed medicines, to or within the UK.

Additional activities:

Since 2013 the MHRA merged with the National Institute of Biological Standards and Control (NIBSC) with the MHRA branding covering the new larger organisation. As such the MHRA can directly undertake research to support the development of new biological medicines and vaccines. It can also perform independent quality testing of batches of biological medicines and develop reference materials for biological medicines to ensure their quality can be assessed in a standard way

The MHRA hosts and supports a number of expert advisory bodies, including the British Pharmacopoeia Commission, and the Commission on Human Medicines.

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.

Website Medicines and Healthcare products Regulatory Agency - GOV.UK (www.gov.uk)