Final Heath Research Authority clinical trials guidance published

The Health Research Authority (HRA) has published final 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.

Over the last year, the HRA has engaged with a range of people and organisations, including researchers, sponsors and industry to make sure the guidance is simple, clear and easy to follow.

The guidance sets out what will change in terms of processes, legal requirements and expectations for clinical trials involving medicines. It covers the updates to the legislation which have been a key focus for the HRA and outlines changes to the review and assessment processes by Research Ethics Committees and the Medicines and Healthcare products Regulatory Agency (MHRA).

The final guidance should be used by sponsors, researchers and anyone involved in setting up and conducting clinical trials to update their processes and policies before the regulations come into effect.

The HRA has been working in partnership with the 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 more about the final guidance.