Australia TGA/PBAC Approval
Videos
Department of Health Pharmaceutical Benefits Scheme (PBS) animation
Pulling back the PBS curtain
Where does the TGA and PBAC fit in?
The Therapeutic Goods Administration, also known as the TGA, is involved in ensuring that the therapeutic goods available for supply in Australia are safe and appropriate for their intended use. They regulate the accessibility and monitor the manufacturing and advertising of products.
Before a medication can be available for public use and access it must be approved by the TGA regarding its safety, quality and efficacy. The Government must then decide which of these medications will be subsidised for patient to ensure affordability. The PBAC (Pharmaceutical Benefits Advisory Committee) assists the government by weighing out the cost and benefits of new medications. Medication that get a positive review will be considered for subsidisation.
Learning Objectives
- Understand the processes undertaken by the department of health in considering and listing medicines and vaccines on the PBS
- Understand the who the PBAC are and what their goals are
- Understand what the PBAC are involved in, and their place in the drug approval process
- Understand who the PBS provides services to