Clinical Trials update – June 2025

UK Health Research Authority are requesting feedback by 10^th September on guidance to the new Clinical Trials Regulation. Note that the new regulation applies to medicinal products, however clinical trials involving combination products, or using IVDs are in scope, although you have to hunt through the Guidance and find the reference to:

Combined trials of an investigational medicinal product and an investigational medical device

For trials that involve both an investigational medicinal product (IMP) and an investigational medical device (IMD), the timelines for a decision to be issued on an initial or amended application will begin from the date of formal acceptance under regulation 16(4) of the Medical Devices Regulations 2002 (i.e. the date on which the application is accepted as valid). Further information on this process can be found in Combined review applications for a combined trial of an IMP and an IMD.

This links to the MHRA pages covering these aspects including for IVDs used in clinical trials of medicinal products.

Please let me have any feedback at regulatory@bivda.org.uk

New clinical trials guidance published

We’ve published new guidance to accompany the updated clinical trials regulations which come into force 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.

Our guidance covers the following updates to the regulations which have been a key focus for the Health Research Authority:

We’re also working on new guidance for public involvement which we plan to publish soon.

Read the new guidance

Shaping the guidance

Earlier this year, we invited feedback on a draft version of the guidance.

We received more than 800 comments which have helped to inform and shape the new guidance.

Thank you to everyone who reviewed the draft guidance and for sharing your feedback.

Further opportunity to share your thoughts

If you have any further comments or would like to share feedback on the new published guidance, please complete our online survey.

You do not have to share feedback on every section of the guidance, just skip to the relevant sections in the survey and add your comments.

The deadline for sharing your feedback is 5pm on Wednesday 10 September 2025.

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

We’ll use the feedback we receive to update the final guidance which we plan to publish later this year.

Complete the survey

MHRA guidance

We’ve been working in partnership with the Medicines and Healthcare products Regulatory Agency (MHRA) to update the clinical trials regulations.

Today, the MHRA has also published guidance to accompany the new regulations.

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Clinical Trials update - June 2025