UK MHRA · August 27, 2025

MHRA launches Route B notification pilot as part of clinical trials regulations rollout

MHRA pilot programme enables sponsors to test new substantial modifications notification process with 14-day response times ahead of regulatory implementation.

Medium impact Clinical Trials & Research UK clinical-trials

The pilot will help sponsors prepare for a new substantial modifications process under upcoming regulations, with responses delivered within 14 days.

Dates and deadlines

Regulatory Deadline

September 10, 2025

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Published by UK MHRA. HealthSignal links to the original document; the summary above is extracted from the source text.