Skip to main content
NSF Home

Revised UK Clinical Trials Legislation

Date
April 16, 2025
Category

UK Regulations

Description

In January 2022 the MHRA launched an 8-week public consultation on proposals for legislative changes for clinical trials and Investigational Medicinal Products (IMPs). In March 2023 the UK government issued their response to this consultation; of the 35 proposals made in the consultation, only four will not be progressed into legislation as a result of the consultation.

The amending legislation was submitted to Parliament on 12 December 2024 and signed into law on 10 April 2025. There is a 12-month implementation period so the revised Regulations will take full effect from 10 April 2026. The MHRA state that the reforms will:

  • Put patients and their safety are at the focus of all clinical trials and bring the benefits of clinical trials to everyone.
  • Cut duplication and unnecessary delays, while maintaining robust oversight of the safety of trials.
  • Create a proportionate and flexible regulatory environment, reducing bureaucracy for lower-risk trials.
  • Cement the UK as a destination for international trials.
  • Provide a framework that is streamlined, agile and responsive to innovation.

By reducing red tape and simplifying approvals, the new framework supports the UK Prime Minister’s target to reduce the time from application to first participant from 250 to 150 days. It will speed up research and reduce the time it takes for promising treatments to reach patients, without compromising on safety.

Virtually all of the changes in the revised Regulations relate to the process for apply to carry out a clinical trial in the UK and to the conduct of the trial itself. There are no changes to the requirements for the manufacture or importation of the investigational medicinal product or the role of the Qualified Person, other than to change the reference to EU GMP legislation from Directive 2003/94/EC to Regulation 2017/1569.

In preparation for implementing the revised regulations, MHRA started the process of producing guidance on seven topics:

  1. Requesting approval for a clinical trial
  2. Modification to a clinical trial
  3. Notifiable trials and the notification scheme
  4. Safety
  5. Research transparency
  6. Simplified means of seeking and recording consent
  7. Ending a clinical trial

MHRA will have the revised guidance finalised by during 2025, prior to the revised regulations going live on 10 April 2026.
Read More: https://www.gov.uk/government/...

For more details please visit: The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025