Although the below update is specific to drug trials it includes information of when sponsors need to make Change notifications/submissions which includes when there are changes to technical equipment used during the trial, or when there are changes to diagnostics used to monitor the trial.
Join our Route B substantial modification pilot
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.
To ensure a smooth transition into the new Clinical Trials Regulations, we will be testing the Route B substantial modification process over the coming months and invite you to get involved.
We are opening a pilot for Route B substantial modifications from 1 October 2025 until 31 March 2026, and encourage you to sign up to take part.
By joining the pilot, you will gain early insight into how the new process works and help us shape it, so it’s ready to support the new regulations from 28 April 2026.
