Therapeutic Goods Administration

Part of the Australian Government Department of Health, the TGA regulates medicines, devices, blood and tissues and maintains the Australian Register of Therapeutic Goods. It participates in the FDA's Project Orbis and in the Access Consortium with Canada, Singapore, Switzerland and the UK, sharing assessments so cancer drugs can be approved in Australia at close to the same time as in the US. Priority and provisional approval pathways allow earlier registration of promising drugs on preliminary data, and the TGA also regulates radiopharmaceuticals, which matters for Australia's leadership in PSMA theranostics. Subsidy is a separate decision by the Pharmaceutical Benefits Advisory Committee.