The Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. The MHRA is an executive agency of the Department of Health.
Aims
The MHRA aims:
- To protect public health through regulation, including the development of benefit and risk profiles for medicines and devices.
- To promote public health by helping people to understand the risks and benefits of the products they use.
- To improve public health by facilitating the development of products that will benefit people.
Key activities:
- To assess the safety, quality and efficacy of medicines, including to authorise their sale or supply in the UK for human use.
- To operate rigorous surveillance and inspection systems for the investigation of adverse reactions to medicines (the Yellow Card Scheme) and to adverse incidents involving medical devices, taking any necessary action to safeguard public health.
- To operate a quality surveillance system to sample and test medicines and to address quality defects, monitoring the safety and quality of imported unlicensed medicines and investigating internet sales and potential counterfeiting of medicines.
- To regulate clinical trials of medicines and medical devices.
- To monitor and ensure compliance with statutory obligations relating to medicines and medical devices through inspection, taking enforcement action where necessary.
- To promote good practice in the safe use of medicines and medical devices.
- To provide the public and professions with authoritative information to enable informed dialogue on treatment choices.
Work with other organisations
The MHRA also works closely with other health bodies including:
National Patient Safety Agency (NPSA)
The NPSA aims to improve the safety of patient care by informing, supporting and influencing healthcare organisations and individuals working in the health sector.
Care Quality Commission (CQC)
The CQC regulates all health and adult social care services in England, whether they’re provided by the NHS, local authorities, private companies or voluntary organisations. It also protects the interests of people detained under the Mental Health Act.
Health Protection Agency (HPA)
The HPA supports and advises the NHS, local authorities, emergency services, the Department of Health and others in its aim of improving public health.
National Institute for Clinical Excellence (NICE)
NICE is an independent organisation that provides national guidance on the promotion of good health and the prevention of ill health.
Others
