Guidance
Route B substantial modification pilot
Clinical trials Route B substantial modifications pilot starts on 1 October 2025. Prepare for the implementation of new regulations from 28 April 2026.
Documents
Details
A Route B substantial modification refers to a specific category of changes made to a clinical trial approval under the .
Updates to this page
Published 18 August 2025
Last updated 21 January 2026
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Updated to fix broken email link
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First published.