MHRA - New Regulations for Clinical Trials: Join Our Route B Substantial Modifications Pilot

17th September 2025

MHRA - New Regulations for Clinical Trials: Join Our Route B Substantial Modifications Pilot

The MHRA’s MedRegs blog announces the launch of a pilot programme under the new UK clinical trial regulations, aimed at testing the Route B process for substantial modifications. This initiative allows sponsors to submit significant changes to ongoing clinical trials in a more efficient manner, reducing administrative burden and accelerating approvals while maintaining patient safety. The pilot also seeks stakeholder feedback to refine the process, ensuring that the new regulatory framework supports innovation, compliance, and timely access to trial updates for investigators and participants.

Link: New Regulations for Clinical Trials: Join Our Route B Substantial Modifications Pilot

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