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Detailed GuideMHRA

Clinical trials for medicines: apply for authorisation in the UK

How to apply for a clinical trial (prior to 28 April 2026) including eligibility, phases, model IMPDs, costs and how to make changes to your application.

First published: Dec 18, 2014Last updated: Mar 31, 2026Changes: 39

Latest change: Removed outdated text in the section ‘Assessment of your submission’. Deleted the section ‘Combined review of clinical trials of an investigational medicinal product’ to remove repeated content. Updated section ‘Applications that need expert advice’ to change timeline from 14 days to 28 days.

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