Detailed GuideMHRA
Clinical trials for medicines: notifiable trials
Guidance on clinical trials that are categorised as ‘notifiable’.
First published: Jun 24, 2025Last updated: Apr 27, 2026Changes: 5
Latest change: 1. Added a copy of the Confirmation of Notifiable Trial Criteria form. 2. Clarified that IND refers to investigational new drug (no change note needed). 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.
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