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 Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025.
Updates to this page
Published 18 August 2025