Updates to Clinical Trials Regulations — Transitional Arrangements Guidance

18th February 2026

Summary: In the updated guidance:

• Clarified notification timelines: Sponsors intending to follow the old pharmacovigilance rules during the transition period must submit their Notification of Intent within the specified timeframe. This ensures their trial safety reporting continues under the legacy framework where appropriate.

• Substantial labelling changes: The guidance emphasises that any labelling updates required to comply with the new clinical trial regulations — and that are substantial — must be approved by the MHRA before use. This means sponsors cannot unilaterally implement significant label revisions without regulatory agreement.

• Post-QP certification labelling: For investigational medicinal products (IMPs) labelled on or after 28 April 2026 (when the new regime takes effect), the guidance adds specific advice on how labelling should reflect the post-Qualified Person (QP) certification status and align with regulatory expectations under the updated regulations.

These targeted updates help sponsors and qualified persons understand their compliance obligations during the transition from old to new UK clinical trial requirements, particularly around pharmacovigilance application timing and product labelling approvals.

Link: https://www.gov.uk/guidance/clinical-trials-regulations-transitional-arrangements

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