10. Roadmap of the submission process of a Clinical Trial

10.1 Clinical Trial with Investigational Medicinal Product

10.2 Pediatric Investigation Plan (PIP)

Australia’s version of the Paediatric Investigation Plan (PIP) is the Paediatric Development Program. TGA:

The Paediatric development program form should be completed and included in Module 1.10 of the dossier.

The form includes advice as to whether there is a pediatric development program for this medicine and provides TGA with information, relevant to the Australian application, about the data submitted, pediatric clinical study commitments given, and waivers received in the European Union and United States of America.

10.3 Clinical Study (Interventional or Observational)

TGA approval is only required for:

• Any medicine not included in the ARTG, such as any new formulation, strength or size, dosage form, name, indications, directions for use, or type of container of medicine already in the ARTG.
• Therapeutic goods already included in the ARTG to be used in a manner not covered by the existing entry in the ARTG.