Clinical Trials regulations signed into law
Source: gov.uk (2025-04-10)

12-month roll-out begins today for the biggest regulatory shake up of clinical trials in 20 years

New regulations for running clinical trials in the UK have now been signed into law. A 12-month roll-out begins today (11 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 (https://www.gov.uk/government/news/patients-the-nhs-and-the-life-sciences-sector-set-to-benefit-from-new-clinical-trials-framework-being-laid-in-parliament-today), 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.

Post-publication note: The new clinical trial regulations will now come into force on 28 April 2026. The date was changed due to a technical issue during the final processing of the Clinical Trial Statutory Instrument (SI) within the digital legislation platform, which meant the SI needed to be re-signed on 28 April 2025.

The reforms will:
- Put patients and their safety are 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.
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 speed up research and reduce the time it takes for promising treatments to reach patients, without compromising on safety.

These reforms will help ensure the UK remains an attractive place to conduct global research, while continuing to protect trial participants through robust oversight.

The Combined Review – a system that lets researchers apply for ethics and regulatory approval in one go – and notification scheme (https://www.gov.uk/government/news/new-streamlined-notification-scheme-for-lowest-risk-clinical-trials-marks-start-of-mhra-overhaul-of-regulation) for some clinical trial initial applications and amendments will now be written into law as part of the changes.

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.

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.”

Janet Messer, Director of Approvals Service at the Health Research Authority, said:

“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.”

Notes to editors

The legislation will be updated here in due course: The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024 (https://www.legislation.gov.uk/ukdsi/2024/9780348267167)

First-ever MHRA analysis of UK clinical trial applications finds new opportunities to drive medical breakthroughs for patients - GOV.UK (https://www.gov.uk/government/news/first-ever-mhra-analysis-of-uk-clinical-trial-applications-finds-new-opportunities-to-drive-medical-breakthroughs-for-patients)

Patients, the NHS and the Life Sciences sector set to benefit from new clinical trials framework being laid in parliament today - GOV.UK (https://www.gov.uk/government/news/patients-the-nhs-and-the-life-sciences-sector-set-to-benefit-from-new-clinical-trials-framework-being-laid-in-parliament-today)

Prime Minister turbocharges medical research - GOV.UK (https://www.gov.uk/government/news/prime-minister-turbocharges-medical-research)

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