New regulations for running clinical trials in the UK have now been signed into law.
A 12-month roll-out began on Friday (Apr 11) 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.
This follows new analysis of clinical trial applications submitted to the MHRA over recent years, highlighting where there are opportunities for accelerating medical breakthroughs.
Lawrence Tallon, MHRA Chief Executive, said: “These new regulations are a key step towards a stronger, more responsive and risk-proportionate clinical trials system that works better for patients.
“They will help ensure people in the UK can benefit sooner from safe, carefully assessed research into new potentially life-saving medicines, while maintaining the highest standards of participant safety.
“By streamlining how trials are approved and run, we are making the UK a more attractive place to deliver high-quality, innovative research. I’d like to thank colleagues across the MHRA, HRA, government, industry and the clinical research community who helped shape these changes.
“We’ll continue to work closely with our partners through the implementation period.”
By reducing red tape and simplifying approvals, the new framework supports the Prime Minister’s target to reduce the time from application to first participant from 250 to 150 days.
It will aim to speed up research and reduce the time it takes for promising treatments to reach patients, without compromising on safety.
Work to bring in the new rules will continue over the coming months, backed by updated guidance and ongoing engagement with trial sponsors and researchers.
“By embedding Combined Review in law, and strengthening the focus on transparency and proportionality, these changes reflect our commitment to making it easier to do high-quality research that people can trust.
“We’ve worked closely with patients, researchers and partners across the system to ensure the new regulations protect participants, while reducing unnecessary burden.
“In the coming months we’ll be publishing guidance to accompany the new regulations to support researchers through the transition period and beyond, so more people can benefit from taking part in safe, well-run research.”
