Launch of clinical trial reforms - GOV. UK From 28 April 2026, Route B will be legally mandated as part of the new regulatory framework Under Route B, eligible modifications are automatically approved unless concerns are raised
Clinical trials regulations reform - Health Research Authority The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 were signed into law in April 2025 Following a 12-month implementation period, the regulations came into force on 28 April 2026
New UK clinical trials regulations now in force From 28 April 2026, Route B will be legally mandated as part of the new regulatory framework Under Route B, eligible modifications are automatically approved unless concerns are raised within 14 calendar days to inform the sponsor that a full assessment is being undertaken
Clinical Trials update - 28 April 2026 The guidance and template document is designed to support sponsors and researchers when developing a research protocol and has been updated to reflect the changes to clinical trials regulations
Clinical trials regulations: six-month countdown begins We remain committed to supporting the clinical trial community to be ready for 28 April 2026 The updates to the regulations will result in new ways of working for researchers, sponsors
New Clinical Trial Regulations come into force from 28 April 2026 Find out what you need to know to prepare for the changes The UK Parliament and Northern Ireland Assembly approved changes to the law governing the regulation of clinical trials involving investigational medicinal products (CTIMPs) across England, Wales, Scotland, and Northern Ireland
New UK Clinical Trial regulations to take effect from 28 April 2026 The UK’s updated Clinical Trial Regulations and Good Clinical Practice (GCP) standards will officially come into force on 28 April 2026, marking a major milestone in the transformation of clinical research regulation