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Health Research Authority seeking feedback on new clinical trials guidance
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 on 28 April 2026
The guidance, which applies UK-wide, 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
The guidance outlines the review and assessment processes for clinical trials of investigational medicinal products (CTIMPs) by Research Ethics Committees and the MHRA.
It does not cover changes to other reviews of CTIMPs, for example study wide review, or non-CTIMP applications. This is because the amended regulations do not apply to these types of studies.
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 5pm 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.
Read the HRA’s latest Clinical Trials update for more information. You can sign up to receive Clinical Trials updates on the HRA website.
Publication date: 8th July 2025
