United Kingdom
Medicines and Healthcare products Regulatory Agency (MHRA) · Europe
Executive summary
Following the end of the Brexit transition period on 31 December 2020, the United Kingdom operates a fully sovereign medicines regulatory system administered by the Medicines and Healthcare products Regulatory Agency (MHRA). For Great Britain (England, Scotland, Wales), authorisations follow the Human Medicines Regulations 2012 as amended; Northern Ireland continues to operate within the EU regulatory framework under the Windsor Framework (since 1 January 2025, the Windsor Framework Pharmaceutical Provisions enable UK-wide MHRA authorisations to cover Northern Ireland). The MHRA International Recognition Procedure (IRP), launched 1 January 2024, replaced the EC Decision Reliance Procedure and provides accelerated review (60 or 110 days) based on prior approval by recognised reference regulators (FDA, EMA, Health Canada, Swissmedic, TGA, PMDA, HSA, MFDS). The IRP has rapidly become the dominant pathway, used in approximately 50% of new MA applications in 2025. The MHRA also operates the Innovative Licensing and Access Pathway (ILAP), refreshed in 2024, providing structured developer support including Target Development Profiles and access to NICE/SMC and the Health Research Authority. The Voluntary Scheme for Branded Medicines Pricing, Access and Growth (VPAG, in force from January 2024 replacing VPAS) and the statutory scheme together cap industry sales growth at 4% with payback rates set annually — the 2024 payback rate was 21.3%, prompting major industry concerns and ongoing renegotiation.
About the authority
MHRA is an executive agency of the UK Department of Health and Social Care. It comprises the licensing authority, the Clinical Practice Research Datalink (CPRD), and the National Institute for Biological Standards and Control (NIBSC). MHRA also operates the Yellow Card Scheme for ADR reporting and is the EU and UK's largest centre for biological standardisation.
International affiliations
Reliance & recognition
MHRA accepts approvals from eight Reference Regulators under the IRP. The agency is also a founding member of the ACCESS Consortium (with TGA, Health Canada, Swissmedic, HSA) for collaborative review and Project Orbis for oncology. Mutual Recognition Agreement on GMP with the EU (2021), USA (2024), and Switzerland is operational.