How does a sponsor know whether to submit a notification (CTN) or application (CTX) to the Therapeutic Goods Administration (TGA) in Australia?
Either route can be used for clinical trials provided that the trial product is not entered on the Australian Register of Therapeutic Goods, including any new formulation of an existing product or any new route of administration; or is a registered or listed product outside the conditions of its marketing approval. Over 95% of trials are approved by the CTN notification route, and the HREC has the responsibility for approving not only how acceptable the study is ethically, but also the safety and efficacy of the medicine or device, approval of the trial protocol and related scientific credibility. A sponsor can conduct any number of trials under the CTX application without any further TGA assessment as long as the product in the study continues under the approvals usage guidelines. However each new trial must be notified to the TGA, but there is no fee for this additional notification under the CTX scheme. If a CTN is submitted legally the sponsor does not have to wait for the TGA’s (T
Related Questions
- When I submit an LCA through the iCERT Portal System, will I receive notification of the status of my application?
- Is payment required for TGA notification (CTN) or approval (CTX) and HREC approval in Australia?
- May a project sponsor submit an Exhibit 2 application in e-snaps on behalf of the Applicant?
