Australia Clinical Trial Notification → Submission & Assessment (Phase 1-5)
Phase 1: Pre-Submission
For a medicine to be registered by the TGA, it must have a sponsor. This is usually the patent holder, which is a pharmaceutical company such as Pfizer or GlaxoSmithKline.
The applicant will submit an initial Pre-Submission Planning Form (PPF) which contains an overview of the medication details, including ingredients, proposed indications, toxicology, risk management plan and a drafted product information. This provides the TGA with the information to decide what resources will be required for the processing and approval of the medication. Once the PPF has been accepted, the TGA decides who will evaluate the dossier. The dossier is a document containing data collected about the medicine to prove its safety and efficacy.
Phase 2: Submission
In this phase, the TGA ensures the application is prepared and ready for evaluation. The dossier must be submitted by the agreed date, and all required payments must also have been lodged. Once submitted, the TGA sends the applicant a notification letter to confirm whether the submission has been accepted or ‘not effective’.
Phase 3: First round assessment
The TGA critically reviews and evaluates the submitted dossier. Evaluators utilize scientific and clinical expertise to assess and analyze evidence on the benefits and risks of the therapeutic product. If the reviewing body requires any extra information or has concerns about any of the content submitted, they will submit a ‘consolidated section 31 request’ to the applicant. If the request is minor or if a formal request is considered unnecessary, the evaluator can contact the applicant directly for extra clarification or to ask a question. If the evaluators require no further clarification from the applicant, a section 31 request does not need to be submitted – these applicants proceed directly to Phase 5.
Phase 4: Consolidated section 31 response
The applicants receive the section 31 request and carefully consider the areas that need addressing as identified by the evaluators. The TGA gives applicants time to gather any extra data or information that has been requested by the evaluators. Once this information is compiled, the applicant must create a response and send this back to the TGA. If the applicant fails to provide a response by the due date, the evaluators will base further review off the original submitted dossier.
Phase 5: Second round assessment
Evaluators review the extra information the applicant has provided in their section 31 response (if applicable). Then, considering all submitted information, they will finish off their evaluation of the product. If there are still issues remaining at this stage, the evaluators will make note of these in evaluation reports. These issues may cause consequences such as conditions for registration, or may be large enough that the product application may be rejected.
