Route B substantial modifications pilot: the results are in

27th April 2026

Summary:
The MHRA has published the results of its Route B pilot, which aimed to streamline the assessment of substantial modifications to clinical trials by enabling more efficient, risk-proportionate reviews. The pilot demonstrated that a tailored approach can reduce timelines and improve the overall experience for applicants, while maintaining regulatory rigour. Feedback from participants highlighted clearer communication and greater predictability as key benefits, supporting the case for wider adoption of this model. The initiative forms part of broader efforts to modernise UK clinical trials regulation and enhance system efficiency.

Link: https://mhrainspectorate.blog.gov.uk/2026/04/27/route-b-substantial-modifications-pilot-the-results-are-in/

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