What does TGA approval of medicines mean?

Abstract

The Therapeutic Goods Administration is a Commonwealth Government agency that regulates medical devices and drugs. Prescription medicines and over-the-counter medicines which meet Australian standards of quality, safety and efficacy are included on the Australian Register of Therapeutic Goods. Medicines may be registered or listed. Registered products are thoroughly evaluated and are labelled with an AUST R number. Listed products, such as complementary medicines, do not have to undergo the same assessments and are labelled with an AUST L number. They are not routinely evaluated before marketing, but are subject to a random audit after listing. Some medicines, such as those compounded for individual patients, are not regulated.