New rules for running clinical trials in the UK have now been officially been signed into law.
The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024 were formally signed by Wes Streeting MP, Secretary of State for Health and Social Care yesterday.
Yesterday (10 April 2025) marks the start of a 12-month implementation period before the amended regulations come fully into force on 10 April 2026.
The updated regulations will soon be available on the legislation.gov.uk website.
The formal legislative process started with the updated regulations being laid before Parliament in December, and concluded earlier this week, with the bill passing through the House of Commons, House of Lords and Northern Ireland Assembly.
Developed by the Medicines and Healthcare Products Regulatory Agency (MHRA) in partnership with the Health Research Authority (HRA), the updated regulations are designed to protect trial participants, reduce unnecessary burdens on researchers, and facilitate the conduct of high-quality, trusted research in the UK.
The changes represents the most significant overhaul of UK clinical trial regulations in 20 years.
Putting people at the centre of research
The updated regulations reflect the feedback of patients, researchers, healthcare professionals, and industry – and aim to make it easier to run safe and inclusive trials.
They will:
- make participant safety and public health central to how trials are designed and run
- reduce duplication and streamline approvals to speed up research
- support a proportionate approach to regulation
- for the first time legally require trial registration on a WHO-recognised public register and the publication of results summaries
Combined Review – a system that lets researchers apply for ethics and regulatory approval in one go – and a new streamlined notification scheme for some clinical trial initial applications and amendments, will also now be written into law as part of the changes.
Janet Messer, Director of Approvals Service“This is an important milestone in improving how clinical trials are set up and run in the UK. 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.”
Lawrence Tallon, Chief Executive, Medicines and Healthcare products Regulatory Agency“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.”
Supporting a smooth transition
With the implementation period now underway, the HRA is working closely with the MHRA and other partners to help sponsors, researchers and trial teams prepare for the changes ahead.
This includes:
- publishing new guidance to support implementation
- hosting training events and webinars to explain what’s changing and what’s expected
- offering opportunities to shape how new transparency requirements are introduced
Over the coming months, our website and regular bulletins will share further updates and ways to get involved.
Share your feedback
If you would like to be involved in reviewing the HRA’s draft guidance before it is published in May, you can download a copy and share you feedback in our online survey.