The University of North Carolina at Chapel Hill
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U.K. Clinical Trial Application → MHRA Response to CTA Application

  • Acceptance of the request for a clinical trial authorization.
  • Acceptance of the request for clinical trial authorization subject to conditions.
  • Grounds for non-acceptance of the request for a clinical trial authorization.
    • MHRA will provide reasons for non-acceptance and the application can be amended and re-submitted.
    • Once amended and re-submitted, the MHRA will typically respond within 60 days of the original valid application.
    • If a gene therapy, somatic cell therapy, or genetically modified organism, the MHRA will respond within 90 days of amended application.

Half of all CTA applications received by the MHRA require additional information to be submitted before being approvable.