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Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA – Announcing our Route B substantial modification pilot

Although the below update is specific to drug trials it includes information of when sponsors need to make Change notifications/submissions which includes when there are changes to technical equipment used during the trial, or when there are changes to diagnostics used to monitor the trial. Join our Route B substantial modification pilot  A Route B substantial modification refers to a…
Ben Kemp
August 21, 2025