TGA (Therapeutic Goods Administration)
The Australian regulatory authority responsible for evaluating and monitoring therapeutic goods including medicines, medical devices, and biologicals. The TGA maintains the Australian Register of Therapeutic Goods (ARTG) and operates independently from the FDA and EMA.
Technical Context
The TGA is part of the Australian Department of Health and operates under the Therapeutic Goods Act 1989. The Australian Register of Therapeutic Goods (ARTG) lists all approved products. Evaluation pathways include: Category 1 (new active substance — full evaluation ~255 working days), Category 3 (product with overseas approval — comparable evaluation relying on foreign assessment ~175 working days), and provisional approval (for serious conditions with unmet need, based on preliminary data). The TGA participates in the ACSS consortium and Project Orbis. Australia's Pharmaceutical Benefits Scheme (PBS) determines government subsidisation of approved medicines — TGA approval is necessary but not sufficient for PBS listing, which requires a separate health technology assessment by the PBAC (Pharmaceutical Benefits Advisory Committee).