RE: The CTA submission ...9 Feb 2021 15:02
Absolutely richob I stand corrected:
The MHRA will process the application based on the type of the trial (Type A, B or C) as described in Risk Adapted Approaches to the Management of Clinical Trials of Investigational Medicinal Products (PDF).
For certain Type A trials, the Clinical Trial Notification Scheme pages of the MHRA web site describe the process and timelines for the CTA application. 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 authorisation.
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.