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Get ready for changes to clinical trials regulations

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

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.

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:

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.

Inclusion and diversity guidance pilot

New GCP guidance

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

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

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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