Information on prescription medicine pre-application requirements.
The pre-submission planning phase is where applicants provide the TGA with details of proposed applications before lodgement of the application dossier. This allows the TGA to identify milestone dates and plan resource requirements.
The Pre-submission planning form (PPF) is used to submit general submission information as well as information about the proposed application type and details of the quality, nonclinical and clinical evidence that will be provided in the dossier.
If the TGA considers a PPF complete and acceptable, the applicant will receive a Planning letter that provides key dates for the phases and milestones of the regulatory process for the application.
Pre-submission meetings may be requested where appropriate and may occur at any stage prior to PPF lodgement.
For more information go to Pre-submission meetings with TGA
To apply for a pre-submission meeting fill out the form at Pre-submission meeting forms
Designations and determinations
- Completing a determination or designation application form in TGA Business Services
- Determination checklist: for sponsor seeking priority review determination
- Designation checklist: for sponsor seeking Orphan Drug designation
- Determination checklist: for sponsor seeking provisional determination
- Prescription medicines determination and designation notices