Before a therapeutic good can be supplied to the Australian market, a company must obtain pre-market approval from the Therapeutic Goods Administration (TGA). In most cases this involves entry of the product in the Australian Register of Therapeutic Goods (ARTG).
The TGA must be satisfied that the product meets requisite standards of quality, safety and efficacy and/or performance before approval can be given. For higher risk therapeutic goods, this usually requires a rigorous scientific evaluation of data submitted by the product sponsor and uses expertise from several scientific fields.
Registrable products include higher risk therapeutic goods such as prescription or non-prescription medicines, implantable medical devices, and devices of animal origin.
Listable products include lower risk therapeutic good such as: vitamins, minerals, herbal medicines, sunscreens and most medical devices.
