The Pre-submission Planning Form (PPF) provides the TGA with the necessary information on the scope and scale of application to arrange appropriate resourcing for the processing and evaluation of an application. When an applicant lodges a PPF, the first phase of the prescription medicines registration process begins.
In February 2023 the TGA made updates to the PPF to include a real world evidence (RWE) usage declaration and the sponsor’s preferred tradename to be published on the TGA’s website whilst the application is under evaluation. The TGA also removed the request for an estimation of hard copy pages that would be included in the submission.
Applicants must ensure they use the most recent version of the PPF.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.