The MHRA Clinical Trials hub on GOV.UK contains draft guidance to support the implementation of the new Clinical Trials Regulations set to come into effect on 28 April 2026. Where appropriate, we have included links to the Health Research Authority’s (HRA) guidance.
We promoted the new draft guidance to a small group of interested and involved members of the clinical trials community and sought their immediate feedback. Now it’s ready for the wider clinical trials community to access.
The CT hub is our one-stop shop for everything we publish about clinical trials, including webinar recordings and links to our current guidance (including information about applying for authorisation in the UK, reporting safety issues, and our phase I accreditation scheme).
We will be adding new content as it becomes available, so please sign up for updates about this page.
Please take some time to review the new draft guidance. We have included a questionnaire in each section, and for a limited time, you can provide us with feedback. We can only accept feedback via the questionnaires.
