New regulations for clinical trials go live on 28 April 2026: Be ready
New – Good Clinical Practice guidance (GCP)
28 April 2026 is the implementation date for the new regulations for clinical trials, and we’ve just added some guidance about Good Clinical Practice (GCP) to our Clinical Trials hub (CT hub).
New draft guidance is about:
Further guidance to follow soon.
We want to ensure that the guidance we provide is useful, clear and concise so, as with previous draft guidance we’ve included a brief questionnaire for your feedback. Please review and submit your comments via these questionnaires, by 11.59 on 8 February 2026.
Read the guidance
What else is new?
We’ve also published information about ICH E6(R3) Annotations.
The Clinical Trials (CTs) with in vitro Diagnostic (IVD) devices webinar will be held on Tuesday, 3 February 2026 from 14:00-15:00 (GMT), providing guidance and advice to sponsors who are submitting clinical trials with in vitro Diagnostic (IVD) devices.
Register your attendance
Updates to existing guidance on new clinical trials regulations
Back in June 2025, we published draft guidance to help you implement the new regulations for clinical trials to be implemented from 28 April 2026. Since then, based on feedback received from the clinical trials community, we have updated some of the existing guidance and continue to update the summary of the key updates made to each set of guidance.
To view the updates, simply:
- Go to the Clinical Trials hub and select the guidance you want to view from the list
- Scroll to the end of the webpage to where it says ‘Last updated’
- Click +show all updates to view a list of changes to the guidance and when they were made.
