Australia TGA/PBAC Approval → Summary

All new medications and vaccinations that are introduced to the market must be assessed by the TGA. Once the therapeutic product (medicines, medical device or biological) has been approved by the TGA, it then gets assessed by the PBAC. Without TGA approval, products cannot be accessed in the market, and are not eligible for listing on the PBS. The PBAC then assesses the product and deems its clinical effectiveness, safety and cost-effectiveness before making a decision about the product. Positive recommendations are then given to the Minister for Health, who will then evaluate the recommendation before deciding if it should be included under the PBS.