What medicines are eligible for the priority registration pathway?
A determination process is used to assess whether a medicine is eligible for the priority pathway but does not necessarily mean that the medicine will be approved after evaluation and registered in the Australian Register of Therapeutic Goods (ARTG).
The eligibility criteria for priority determination are designed to ensure that only medicines providing the most benefit to patients are eligible. Priority review is based on a full dossier and substantial evidence. The eligibility criteria are:
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.