Prior approval/acknowledgement by the TGA to conduct a clinical trial is required before commencing a trial
In Australia there are two main routes for conducting a clinical trial of a new therapeutic good or new uses of therapeutic goods- the Clinical Trial Exemption (CTX) Scheme, and the Clinical Trial Notification (CTN) Scheme. These schemes are used for clinical trials involving:
Clinical trials in which registered or listed medicines or medical devices are used within the conditions of their marketing approval are not subject to CTN or CTX requirements but still need to be approved by a Human Research Ethics Committee (HREC) before the trial may commence.
The CTX Scheme is an approval process and the CTN Scheme is a notification process. Over 95% of all trials conducted in Australia obtain regulatory approval via the CTN scheme.
For the complete guide to conducting clinical trials in Australia refer to the Access to Unapproved Therapeutic Goods – Clinical Trials in Australia document.