The University of North Carolina at Chapel Hill
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U.K. Clinical Trial Application → Reviewal

The MHRA will review the application based on what type of trial being conducted (A, B, or C).

  • For certain Type A Trials- Once the application is sent to the MHRA, it will be acknowledged with an accompanying note to say that the trial may go ahead after 14 days from receipt of notification if no objections have been raised. The acknowledgement letter will act as the authorization.
    • This expedited 14 day period is designated for healthy volunteer trials and sponsor-determined non-oncology patients.
  • For Type B and C Trials- The notification scheme is not applicable and each application will be fully assessed by the MHRA. They will provide an initial response within 30 days of receipt of a valid application, with an average of 14 days for Phase 1 healthy volunteer studies