Medicines and TGA classifications

Australia has a two-tiered system for the regulation of medicines, including complementary medicines:

  • Higher risk medicines must be registered on the Australian Register of Therapeutic Goods (ARTG), which involves individually evaluating the quality, safety and effectiveness of the product.
  • Lower risk medicines containing pre-approved, low-risk ingredients and that make limited claims can be listed on the ARTG.

Within the regulatory framework, medicines are classified as either registered or listed:

Registered medicines

Registered medicines are assessed by the TGA for quality, safety and efficacy.

Listed medicines

Listed medicines are assessed by the TGA for quality and safety but not efficacy.

  • Some over-the-counter medicines are listed.
  • Most complementary medicines are listed.