# Clinical trials for medicines: Notification of Serious Breaches of GCP or the trial protocol

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/40312693-9d17-4435-a24e-cec04ab6c613
Type: Guidance
Published: April 27, 2026

> This official guidance from the UK Medicines and Healthcare products Regulatory Agency (MHRA) outlines the formal implementation of updated standards for clinical research. Effective from April 28, 2026, the guidance has transitioned from its draft phase to a finalized regulatory document. It is designed to complement the Medicines for Human Use (Clinical Trials) Regulations 2004 and the subsequent 2025 Amendment Regulations. As this is a general regulatory update rather than an inspection report for a specific entity, it does not list a single company name, specific inspection dates, or individual violations. Instead, the regulatory framework applies universally to all organizations conducting clinical trials in the United Kingdom. The primary objective is to modernize the oversight of clinical research, ensuring that trial procedures remain robust and ethically sound under the new legal provisions. Required actions for all relevant stakeholders include immediate adherence to the finalized guidance and ensuring that trial protocols are updated to reflect the 2025 statutory changes. Failure to follow these updated guidelines may result in non-compliance with UK law. The MHRA expects all sponsors and researchers to integrate these standards into their current operating procedures to maintain high levels of participant safety and data reliability across the sector.

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## Content

The amended Clinical Trials Regulations took full effect on 28 April 2026. As such, this guidance should now be considered effective and is no longer in draft. This guidance accompanies the Medicines for Human Use (Clinical Trials) Regulations 2004, as amended by the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025.

## Attachments

- [Notification of Serious Breaches of GCP or the trial protocol](/government/publications/clinical-trials-for-medicines-notification-of-serious-breaches-of-gcp-or-the-trial-protocol/notification-of-serious-breaches-of-gcp-or-the-trial-protocol)
- [Template - Notification of serious breach form](https://assets.publishing.service.gov.uk/media/6a04838a22977ebc82cb3f01/Notification_of_Serious_Breach_Form_v8_28April2026.docx)