Final clinical trials guidance published
Our final guidance to accompany the amended clinical trials regulations has now been published.
The guidance sets out what will change in terms of processes, legal requirements, and expectations for clinical trials involving medicines when the updated regulations come into force on 28 April 2026.
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 (RECs) and the Medicines and Healthcare products Regulatory Agency (MHRA).
This guidance should be used to update your processes and policies in advance of the amended regulations coming into effect.
The MHRA has also published final guidance to accompany the updated regulations which you can read on their clinical trials hub.
Shaping the guidance
Our final guidance reflects feedback from an online survey we ran from June to September, in which we asked you to review the guidance and share your thoughts on how it was written.
We’ve updated a number of areas of the guidance, including sections on definitions, approvals processes, transparency requirements, pharmacovigilance, simplified arrangements for consent, and RECs that review clinical trials.
In response to your feedback, we’ve also created an extra piece of transparency guidance for sponsors about sharing trial results.
Thank you to everyone who has been involved in helping shape the guidance to make sure it’s simple, clear and easy to follow.
Writing the guidance – a look behind the scenes
Over the last year, we’ve collaborated with a range of people and organisations to produce our guidance to accompany the updated clinical trials regulations.
Catherine Blewett and Chris Cole, who are part of the team working on the implementation of the regulations for the HRA, share an insight into the process to develop the guidance and the extensive engagement that took place.
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