Clinical Trials update - 28 January 2026

Health Research Authority sent this bulletin at 28-01-2026 03:55 PM GMT

Having trouble viewing this email? View it as a Web page.

Graphics says 'HRA Clinical Trials update, 28 January 2026'

Get ready for changes to clinical trials regulations

Graphics says '90 days until clinical trials regulations come into force'

It’s 90 days until amended clinical trials regulations come into force.

Our guidance on changes to the clinical trials regulations 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’re encouraging all researchers and sponsors to read our guidance and to update policies, processes and procedures ahead of the changes going live.

If you have any questions about the HRA’s clinical trials regulations guidance, please contact our engagement team.

Changes to other types of research

The amended regulations only apply to CTIMP studies. We’re introducing changes, in line with the regulations, to other types of health and social care research (referred to as non-CTIMPs).

The changes will promote consistency across health and social care research in the UK and will streamline the applications process.

This will make it simpler for sponsors and researchers to obtain regulatory approval.

The changes to non-CTIMPs include:

‘amendments’ to become ‘modifications’
updated categories for modifications
updated approvals timelines for applications and modifications
updates to research transparency registration and deferral timelines

We’ve published new guidance to explain the requirements and to help researchers and sponsors get ready.

Find out more

Definitions and terminology – what’s changing and why

Some of the definitions and terminology we use for CTIMPs are changing when the amended regulations come into effect. These include:

‘amendments’ to become ‘modifications’
new modification categories
an update to the definition of a health care professional

Dr Catherine Blewett, Senior Development Manager, has written a blog to highlight all the changes and to explain why they’re being introduced and what they will mean for sponsors and researchers.

Read Catherine's blog

Countdown to compliance: new UK clinical trial transparency requirements webinar

Our Head of Policy and Engagement, Clive Collett, is joining a panel of speakers at a webinar about upcoming changes to research transparency requirements as part of the amended clinical trials regulations.

The webinar, organised by Citeline, takes place on Wednesday 25 February from 3pm to 4pm (UK time).

Attendees will learn how to navigate registration requirements, manage deferrals for commercially sensitive information, meet plain language summary obligations for participants, and build sustainable transparency practices beyond 28 April 2026.

Book your free place

Inclusion and diversity guidance pilot

Thank you to everyone who took part in our pilot to help us draft inclusion and diversity guidance.

We launched the pilot in May 2025 following the publication of the updated second draft of guidance for how to develop an Inclusion and Diversity Plan.

Our pilot, which closed for new applications in December 2025, invited sponsors and researchers to develop an Inclusion and Diversity Plan and submit it as part of an application for review by a Research Ethics Committee (REC).

7 studies have been involved in the pilot and we’re now gathering and reviewing feedback from the sponsors, researchers and ethics committee members who took part.

We’ll share more on this and next steps soon.

New GCP guidance

The MHRA has published new guidance on Good Clinical Practice (GCP) ahead of the updated clinical trials regulations coming into force.

The draft GCP guidance covers:

Declaration of Helsinki and clinical trials regulations alignment
archiving and retention of clinical trial records
clinical trials regulations enforcement provisions

Read the guidance and give feedback on the MHRA’s Clinical Trials hub.

Clinical trials with in vitro diagnostic devices webinar

The MHRA is holding a webinar on Tuesday 3 February 2026 from 2pm to 3pm for sponsors who are running, or may want to run, clinical trials with investigational in vitro diagnostic (IVD) devices.

The webinar will provide advice and guidance on:

clinical trials with IVDs
the internal assessment process and timelines
tips for accelerating clinical trial approval
submitting or amending your clinical trial with an IVD
requirements for submission to REC and study wide review

Register for the webinar

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.

Share your feedback

To help us make sure we’re sharing the right information in these updates, please complete our short two question survey.

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