MHRA Updates Guidance on Ending Clinical Trials

10th October 2025

MHRA Updates Guidance on Ending Clinical Trials

Summary: The Medicines and Healthcare products Regulatory Agency (MHRA) has published revised guidance on ending clinical trials, effective from 28th April 2026. The updated guidance outlines the requirements for notifying authorities when a clinical trial has ended, including timelines for notification and the process for submitting end-of-trial declarations.

Key Updates:

• Notification Timelines: Sponsors must provide written notice to the licensing authority and ethics committee within 90 calendar days if the trial ends as specified in the protocol, or within 15 calendar days if the trial is terminated earlier than planned.

• Publication of Results: Sponsors are required to publish a summary of the results in a public registry within 12 months of the trial's conclusion.

• Lapse of Clinical Trial Approval: If no participants are recruited within two years of the trial's approval, the clinical trial approval will lapse. Sponsors can apply for an extension by contacting the MHRA.

These updates aim to streamline the process of ending clinical trials and ensure compliance with the new regulations.

Link: Clinical Trials for Medicines: Ending a Clinical Trial

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