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

Join the HRA and MHRA at our clinical trials regulations webinar

The Health Research Authority (HRA) and Medicines and Healthcare products Regulatory Agency (MHRA) are holding a webinar about the changes to clinical trials regulations that come into effect on 28 April 2026.

The Clinical Trials Regulations: Countdown to Implementation webinar takes place online on Thursday 12 March from 2pm to 4pm (GMT).

We’ll cover the key changes in the updated regulations, the guidance we’ve published to support you through the transition, and our panel of HRA and MHRA experts will be on hand to answer your questions.

The webinar will be recorded, so if you can’t join, the recording will be made available soon after.

If you have any queries about the webinar, please email conferences@mhra.gov.uk

Countdown to regulations: 70 days 

Today marks 70 days until the amended regulations come into force.

Ahead of the webinar next month and 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).

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. 

Guidance for non-CTIMP clinical trials and other types of research

From 28 April 2026, we’re making some changes to how non-CTIMP studies are processed and managed to streamline the applications process.

The changes are in line with the updated clinical trials regulations and will make it simpler for sponsors and researchers to apply for and earn approvals.

In January, we published new guidance to explain the requirements and to help researchers and sponsors get ready.

Our guidance covers:

• updates to ‘amendment’ terminology for non-CTIMPs
• the approvals process for non-CTIMPs
• the approvals process for non-CTIMP modifications (amendments)
• research transparency requirements for non-CTIMP clinical trials

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

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.

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