New clinical trials guidance published

The Health Research Authority (HRA) has published new guidance to accompany the updated clinical trials regulations which come into force across all four nations of the UK (England, Wales, Scotland and Northern Ireland) on 28 April 2026.

The guidance explains what will change in terms of processes, legal requirements, and expectations for anyone involved in setting up or delivering clinical trials. It covers the following updates to the regulations which have been a key focus for the HRA: 

• definitions and terminology
• pharmacovigilance
• the approvals process for clinical trials
• Research Ethics Committees that review clinical trials
• simplified arrangements for consent in clinical trials
• research transparency requirements for clinical trials

If you have any comments or would like to share feedback on the new published guidance, please complete the HRA’s online survey. The deadline for sharing your feedback is 17:00 on Wednesday 10 September 2025.

If you would prefer to provide your feedback on how the guidance is written by email, or you have any questions, please email the HRA's engagement team.

The feedback will be used to update the HRA’s final guidance which will be published later this year.

The HRA has been working in partnership with the Medicines and Healthcare products Regulatory Agency (MHRA) to update the clinical trials regulations. The MHRA has published separate guidance which covers the key areas of the regulations which they have been focusing on.