Appendix 1: Description of MHRA divisions and centres
Updated 16 December 2021
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1. Licensing
The Licensing division is responsible for assessing and approving applications for marketing authorisations. It also comprises a Clinical Trials Unit which assesses and grants clinical trial authorisations for applications from Sponsors wishing to conduct clinical trials with medicinal products. Scientific advice is available to Sponsors proposing to apply for marketing authorisation applications.
2. Inspection, Enforcement and Standards
Inspection, Enforcement and Standards (IE&S) is responsible for ensuring compliance with the standards that apply to the manufacture and supply of medicines on the UK market. This is achieved by licensing, inspection and enforcement across the full lifecycle of medicines, including manufacturers, wholesale dealers and importers of medicines and by inspecting clinical trials, toxicology laboratories and pharmacovigilance systems.
3. Vigilance and Risk Management of Medicines
The Vigilance and Risk Management of Medicines division (VRMM) protects public health by ensuring the safety, quality and efficacy of medicines, including the provision of information to promote safe and effective use. It conducts post-marketing surveillance and operates the Yellow Card and other systems for reporting, investigating and monitoring adverse reactions to medicines. VRMM takes any necessary action to safeguard public health, for example through safety warnings or removing or restricting the availability of products.
4. Devices
The Devices division provides expertise relating to safety, quality and performance of all medical devices. It is also the UK Competent Authority for the Medical Devices Regulations. The division deals with the whole spectrum of medical devices and equipment and evaluates medical device issues and co-ordinates incident investigations with manufacturers and users.
5. Clinical Practice Research Datalink
Clinical Practice Research Datalink (CPRD) is a centre of the MHRA and provides real-world research services to support retrospective and prospective public health and clinical studies. CPRD collects de-identified patient data from a network of GP practices across the UK which is linked to a range of other health related data to provide a longitudinal, representative UK population health dataset. CPRD has experience of supporting RWD trials using an integrated interventional research platform based on electronic healthcare records to increase research efficiency in the design, conduct and delivery of trials.