UK Clinical Trials Regulations: Six-Month Countdown

On 28 April 2026, significant updates to the UK clinical trials regulations will come into force.

Background

The implementation of the latest international Good Clinical Practice (GCP) guidelines (ICH-GCP E6(R3)) will come into force in the UK, along with updated UK regulations. All trials will need to adhere to GCP principles, and trials for marketing authorization will need to comply with the full guidelines. By streamlining approval processes, reducing duplication and supporting a proportionate and flexible approach it will be quicker and easier to set up and run clinical trials, while maintaining the highest standards of safety. According to the MHRA, this will speed up research that could lead to new and better treatments for patients.

Further Steps

• In December 2025, the MHRA will publish a list of changes to definitions.
• Draft guidance for Good Clinical Practice (GCP) will be published on the MHRA clinical trials hub in January 2026. 
• In March the MHRA will also provide updates to the process for the Modification of an Important Detail (MOID).

Further Information is available at the MHRA Inspectorate Blog.