UK MHRA · August 27, 2025

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

MHRA pilot programme to help sponsors prepare for new substantial modifications process under upcoming clinical trials regulations.

Low obligation Sector 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

Read the official source ↗

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