The TGA have recently released the revised Australian clinical trial handbook and it is now available on their website.

The Handbook has been updated to reflect current practice. The TGA have also consolidated information from the following previous clinical trials guidance documents:

  • Access to unapproved therapeutic goods – Clinical trials in Australia
  • Australian Clinical Trial Handbook
  • Human Research Ethics Committees and the therapeutic goods legislation

The updated Handbook provides policy guidance on the clinical trials schemes administered by the TGA. Guidance on the notification process for the Clinical Trial Notification (CTN) scheme is available at Clinical trial notification form – user guide. Guidance on the application process for the Clinical Trial Exemption (CTX) scheme is currently under review.

Please contact the clinical trials team at clinical.trials@health.gov.au for any further information or clarification.