How long does it take to get approval for Clinical Trials to be conducted in Australia?
Applicants should allow for a total time period of 2-3 months. Notification (CTN) or an application (CTX) is required to the TGA (Therapeutic Goods Administration). The CTX application can be made under 50 or 30 day review, and has associated costs. Ethics approval is obtained from the applicable institutional HREC (Human Research Ethics Committee). The ethics application is required to be submitted 2-6 weeks prior to the ethics meeting. Average approval time depends on the ethics committee, and varies depending on the geographical area.
