The UK Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance “Clinical Trials for Medicines: Modifying a Clinical Trial Approval.” The latest version was published on 8 June 2026, updating the original guidance issued on 25 June 2025.
The guidance provides detailed information on the various types of modifications that may be made to an approved clinical trial and outlines the applicable requirements and procedures for submitting modification requests to the MHRA.
Sponsors conducting clinical trials in the United Kingdom should review the updated guidance to ensure that any proposed changes to trial protocols, documentation, investigational medicinal products, or other aspects of an approved study are managed in accordance with current regulatory requirements.
The updated guidance can be accessed here.
For support with UK clinical trial submissions, modifications, or regulatory compliance requirements, please contact the MDSS team.
