Medicines regulation in the United Kingdom

The national authority

The Medicines and Healthcare products Regulatory Agency (MHRA) is the United Kingdom's regulator for medicines, medical devices and blood components. It is an executive agency of the Department of Health and Social Care. Its work spans licensing new medicines, overseeing clinical trials, inspecting manufacturing and supply chains, monitoring safety, and regulating devices placed on the UK market.

Its legal base is the Human Medicines Regulations 2012, the Medical Devices Regulations 2002 and related law, which has been developing on a UK-specific track since the UK's departure from the European Union.

How products reach the market

Medicines need a marketing authorisation from the MHRA before they can be sold in the UK. Clinical trials require MHRA authorisation together with research ethics committee approval, and are registered publicly. Devices placed on the Great Britain market require UKCA marking or currently accepted CE marking under transitional arrangements, with registration through the MHRA; Northern Ireland follows EU device rules.

Public records and registries

Product information for licensed medicines - summaries of product characteristics and patient information leaflets - is published openly. Safety alerts, drug safety updates and inspection outcomes are public. The Yellow Card scheme collects suspected adverse drug reaction reports from clinicians and the public, and publishes aggregated safety data.

Using this profile

This is a structural orientation, not legal or regulatory advice. Post-transition arrangements have been evolving; anyone acting on a real submission should work from the authority's current guidance or a qualified regulatory professional.