Biggest reform of UK clinical trials regulations in 20 years signed into law
New regulations for running clinical trials in the UK have now been signed into law. A 12-month roll-out began on 11th April to deliver the most significant update to UK clinical trials regulation in two decades – with the aim of strengthening patient safety, accelerating approvals, enabling innovation and helping more people benefit from taking part in vital research.
First laid in Parliament in December 2024, the updated regulations are designed to put participants firmly at the centre of how trials are run, while supporting a faster, more streamlined approvals, making it easier to test new treatments in the UK.
The MHRA is committed to implementing a flexible and risk-proportionate regulation of clinical trials, which accelerates patient access to potentially life-saving medicines without compromising safety.
This follows new analysis of clinical trial applications submitted to the MHRA over recent years, highlighting where there are opportunities for accelerating medical breakthroughs.
The new regulations will take full effect from 10 April 2026, following the 12-month implementation period starting this week. They were developed by the Medicines and Healthcare products Regulatory Agency (MHRA), in partnership with the Health Research Authority (HRA), and shaped by feedback from patients, researchers, doctors, and industry.
The reforms will:
- Put patients and their safety at the focus of all clinical trials and bring the benefits of clinical trials to everyone.
- Cut duplication and unnecessary delays, while maintaining robust oversight of the safety of trials.
- Create a proportionate and flexible regulatory environment, reducing bureaucracy for lower-risk trials.
- Cement the UK as a destination for international trials.
- Provide a framework that is streamlined, agile and responsive to innovation
Source: Clinical Trials regulations signed into law – GOV.UK
