The Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe. The MHRA is an executive agency of the Department of Health.
MHRA main activities are
- assessing the safety, quality and efficacy of medicines, and authorising their sale or supply in the UK for human use.
- overseeing the UK Notified Bodies that audit medical device manufacturers.
- operating post-marketing surveillance and other systems for reporting, investigating and monitoring adverse reactions to medicines and adverse incidents involving medical devices and taking any necessary action to safeguard public health, for example through safety warnings, removing or restricting the availability of products or improving designs
- operating a proactive compliance programme for medical devices.
- operating 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.
- regulating clinical trials of medicines and medical devices.
- monitoring and ensuring compliance with statutory obligations relating to medicines and medical devices through inspection, taking enforcement action where necessary.
- promoting good practice in the safe use of medicines and medical devices.
- managing the British Pharmacopoeia (BP) and contributing to the development of performance standards for medical devices; offering scientific, technical and regulatory advice on medicines and medical devices.
- providing the public and professions with authoritative information to enable informed dialogue on treatment choices.