Medicines and Healthcare products Regulatory Agency

Rule Changes

Co-author and primary enforcer of the reformed framework

For more than two decades, running a clinical trial in the United Kingdom meant navigating a framework written in 2004 for a different era of medicine. On 28 April 2026, that framework was retired. New regulations from the Medicines and Healthcare products Regulatory Agency (MHRA) and Health Research Authority (HRA) introduce a fast-track route for lower-risk studies, formalise a seven-day approval pathway for trial modifications, and make registration and publication of summary results a legal requirement for the first time.

Updated 3 hours ago