The new clinical trials regulations come into force on 28 April 2026.
The regulations will introduce new legal requirements for research transparency in clinical trials of investigational medicinal products (CTIMPs) in the UK.
They will require sponsors of CTIMPs in the UK to:
- register a clinical trial in a public registry before the recruitment of the first participant or within 90 days of approval of the clinical trial (whichever is sooner)
- publish a summary of the results within 12 months of the end of the trial
- offer to share a summary of the results with participants or relevant individuals (this should be in a suitable format and in a manner that's understandable to participants or those who may have provided consent on behalf of the participant or other relevant people)
Failure to comply with the requirements to register or publish a summary of results (without any deferral or waiver) will constitute an offence under the new legislation and, if not corrected, may result in action being taken by the Medicines and Healthcare products Regulatory Agency (MHRA).
We’ll work with the MHRA to support compliance with the new regulations. For further information on how regulations can be enforced, read the MHRA's guidance.
Where justified, deferrals (and, in rare cases, waivers for national security reasons) to these new requirements will be allowed. In addition, if you submit an application for clinical trial authorisation and an ethics committee opinion for a CTIMP before 28 April 2026, the application may not have to meet some of these transparency requirements.
The following pages provide more information on the new requirements, what trials they apply to and seeking deferrals or waivers for the transparency requirements: