04.08 Therapeutics Goods Administration

The Therapeutic Goods Regulations (TGA) is responsible for the quality, safety, efficacy, and timely availability of drugs and medical devices in Australia. The TGA regulates prescription, over-the-counter and complementary medicines. It usually accepts the recommendations coming from the Australian Drug Evaluation Committee (ADEC). ADEC is a committee of specialists that are able to evaluate pharmaceutical and chemical data, animal pharmacology and toxicology data, and clinical data. Applications are usually 100,000 pages in length, and the review by physicians/scientists takes up to 3 years. For serious conditions, may get approval earlier in the trialling process and in a shorter time. After registration, drugs can be administered to patients outside of clinical trials at full cost.