22 Sep 25
The MHRA has launched a pilot for the new Route B substantial modification process, ahead of the amended UK clinical trials regulations coming into force in 2025.
Route B will allow for automatic MHRA approval of substantial modifications that meet pre-defined criteria set out in Section 11B of the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025.
These criteria apply where there are no new safety issues and the modification is either:
• the same change already approved for a non-First in Human trial in the EEA/USA,
• limited to specific protocol changes, or
• restricted to defined IB/SmPC updates.
With responses delivered within just 14 days, the pilot will help sponsors prepare for the new process and streamline substantial modifications under the upcoming regulations.
Need guidance on preparing for Route B?
Our experts at tranScrip can help you interpret the eligibility criteria, streamline the registration process, and ensure your trial is ready for the new regulatory landscape.
Contact us to discuss how we can support your clinical development plans.
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