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.
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.
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, the HRA website and regular bulletins will share further updates and ways to get involved.
