Health Research Authority

Rule Changes

As of May 2026: Co-author of reforms; runs ethics and registration system

Running a clinical trial in the United Kingdom required navigating a 2004 framework for more than two decades, but on 28 April 2026, it 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 and a seven-day approval pathway for trial modifications. Registration and publication of summary results become legal requirements for the first time.

Updated May 31