Australia
Therapeutic Goods Administration (TGA)
Verified 12 September 2026 by Wilson Blaney, ACQI, RP (GDP) trained
5 days agoMarketing authorisation fees were re checked against the regulator. The priced pathways below are confirmed against the schedule named in each note. Where a pathway shows no amount, the regulator publishes no single figure for it or the figure could not be confirmed, and this is stated in the note rather than estimated.
3 of 5 pathways carry a confirmed fee
Contributor Wilson Blaney, ACQI, RP (GDP) trained
Australia operates a single-payer-influenced market regulated by the Therapeutic Goods Administration (TGA), part of the Department of Health and Aged Care. Therapeutic goods must be entered on the Australian Register of Therapeutic Goods (ARTG) before supply, under the Therapeutic Goods Act 1989. TGA is a strong reliance regulator: the Comparable Overseas Regulator (COR-A and COR-B) pathways and ACCESS Consortium work-sharing (with Health Canada, MHRA, Swissmedic, HSA Singapore) provide expedited review where a product has been approved by FDA, EMA, MHRA, Health Canada, or Swissmedic. Reimbursement on the Pharmaceutical Benefits Scheme (PBS) requires a separate, often demanding, Pharmaceutical Benefits Advisory Committee (PBAC) submission with cost-utility evidence. Many sponsors therefore plan a parallel TGA/PBAC strategy, since registration without PBS listing severely limits commercial uptake.
About the authority
TGA sits within the Australian Government Department of Health and Aged Care. It regulates prescription medicines, OTC products, biologicals, complementary medicines, and medical devices. Prescription medicines are evaluated by the Medicines Regulation Division. Sponsors must be Australian-incorporated entities. Full cost recovery applies, almost all TGA activities are funded by sponsor fees.
Reliance & recognition
TGA operates two formal reliance pathways (COR-A, COR-B) plus participates in the ACCESS Consortium (with HC, MHRA, Swissmedic, HSA) and Project Orbis (FDA-led oncology). Joint reviews and work-sharing are increasingly common. GMP clearance can be obtained via reliance on inspections by EU MRA partners, MHRA, FDA, Health Canada, and PIC/S authorities.
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Other Asia-Pacific markets
Same structure. Same source-citation standard.