Clinical Trials update - 19 December 2025

Health Research Authority sent this bulletin at 19-12-2025 05:11 PM GMT

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Clinical trials regulations – time to prepare

A graphic which says 130 days until clinical trials regulations come into effect

Updated clinical trials regulations come into force in 130 days.

We’re encouraging all researchers and sponsors to update their policies, processes and procedures and to start preparing for the changes as soon as possible.

To help you prepare, please read our guidance which sets out what will change in terms of processes, legal requirements, and expectations for clinical trials of investigational medicinal products (CTIMPs) when the regulations come into effect on 28 April 2026.

The Medicines and Healthcare products Regulatory Agency (MHRA) has also published guidance to accompany the updated regulations which you can read on their clinical trials hub.

We’ll be sharing more information and support to make sure you’re fully prepared ahead of the regulations going live – keep an eye out for more updates in the new year.

A review of 2025 and a look ahead to next year

As the year draws to a close, our Chief Executive, Matt Westmore, has written a blog to reflect on how the Health Research Authority (HRA) has supported research in the UK throughout 2025.

In the blog, Matt also looks ahead to 2026 and writes about the importance of the updated clinical trials regulations and the impact they will have, along with our other work, on the future of UK health and social care research.

Read Matt's blog

Insurance review in Phase 1 clinical trials

Alastair Nicholson, Head of Co-ordination and Standardisation for the HRA, and Rachel Mead, Senior GCP Inspector at the MHRA, have written a joint blog to clarify the insurance requirements for Phase 1 clinical trials when the updated clinical trials regulations come into effect.

The blog post includes information about:

responsibilities
making sure you have appropriate cover
where to get help and guidance

Read the blog

Inclusion and diversity in clinical trials

In the lead up to the updated clinical trials regulations coming into effect, we’re writing a series of articles with the MHRA. 

Our latest article, published in the Drug Information Association’s Global Forum online journal, looks at how embedding inclusion and diversity in UK clinical trials is central to addressing inequity.

We explore:

the importance of diversity in clinical trials
current barriers to inclusive and diverse research
HRA and MHRA inclusion and diversity guidance
how we're supporting embedding a culture of inclusion in clinical trials

Read the article

Route B substantial modifications pilot

In October, the MHRA launched a Route B substantial modifications pilot, which will run until 31 March 2026.

The pilot will expand the MHRA’s risk-proportionate approach to include the review of modifications to approved clinical trial applications.

Under the amended regulations, substantial modifications (previously known as amendments) that meet pre-defined criteria will be eligible for automatic approval by the MHRA.

Please note that the Route B substantial modification process does not apply to the Research Ethics Committee (REC) review process.

You can find out more about the pilot and how to take part in this MHRA blog.

Christmas opening hours

Our opening hours are changing over Christmas and New Year.

If you need to get in touch with us between Friday 19 December 2025 and Monday 5 January 2026 please make sure you check our website for the best contact details.

Take a look at our Christmas opening hours

HRA and research news

Interested in finding out more about the HRA and our work? We have a range of different newsletters to suit your interests.

HRA Latest – a monthly newsletter to keep you up-to-date with our latest news and developments

HRA Now – an operational bulletin aimed at those working in and supporting the set up and delivery of research

HRA public involvement newsletter – news and information about public involvement in health and social care

Building better research services newsletter – the latest information on our work to improve the digital services used in the UK to plan, manage and deliver health and social care research

Sign up to our newsletters

If you would like to find out more about health and social care research and opportunities to get involved in studies, sign up to the National Institute for Health and Care Research (NIHR) newsletters.

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If there’s anything you would like to hear about in future updates, please let us know by emailing communications@hra.nhs.uk