Therapeutic Goods Administration
Australian regulator; adopts the PIC/S GMP Guide as its manufacturing principles.
WHAT TGA COVERS
The Therapeutic Goods Administration regulates medicines, medical devices, biologicals, and blood products in Australia under the Therapeutic Goods Act 1989. Products supplied in Australia must generally be included in the Australian Register of Therapeutic Goods, and manufacturers require TGA licensing or an acceptable GMP clearance.
WHERE IT SITS INTERNATIONALLY
The TGA is a PIC/S participating authority and an ICH member, and participates in mutual recognition and cooperation arrangements with other trusted regulators.
HOW ITS REQUIREMENTS BITE
The TGA adopts PIC/S PE 009 as the Australian GMP code rather than writing its own, and licenses domestic manufacturers following inspection. Overseas manufacturers supplying Australia generally obtain GMP Clearance, which can rely on evidence from a comparable overseas regulator — a desktop route that avoids duplicate inspection where the foreign authority is trusted.
WHAT TGA PUBLISHES
- 01The adopted PIC/S Guide to GMP (PE 009) as the Australian code, with any TGA-specific annexes
- 02GMP Clearance guidance and the manufacturer licensing framework
- 03Australian Regulatory Guidelines (ARGPM for prescription medicines, ARGMD for devices)
- 04Safety alerts, recall actions, and the Database of Adverse Event Notifications
- 05Uniform Recall Procedure for Therapeutic Goods
WHAT PRACTITIONERS GET WRONG
- ›Australia adopts PIC/S PE 009 directly — a PIC/S-compliant site starts already substantially aligned.
- ›GMP Clearance based on a comparable overseas regulator’s evidence is the usual route for foreign manufacturers.
- ›Check which PE 009 version and any TGA-specific deviations are currently adopted; adoption lags publication.
- ›ARTG inclusion is the market-access gate, separate from manufacturer licensing.
TGA STANDARDS SPEQ DECODES · 1
DISCIPLINES IN TGA’S REMIT
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