Below is more information on the regulatory approval system for medicines in Australia:

Scientific evidence requirements

Medicines should be studied in accordance with regulatory and controlled clinical trials, involving large groups of subjects, to determine safety, efficacy and quality. Publication of clinical trials is mandatory.

Quality standards

Each drug must meet the Therapeutic Goods Administration (TGA) standards for quality (including purity, stability, and batch-to-batch consistency). Each batch of product is tested against the product manufacturing specifications agreed upon by regulatory bodies at the time of approval. This ensures that approved drugs contain uniform concentrations of the active ingredients and other components listed in the technical data sheet, including impurities and breakdown products.1-3

This allows for the recall of a specific product from the market, verification of authenticity or the recall of individual batches in the event of security concerns identified.


Once approved, the drugs can be legally prescribed in all countries where the product has been approved.1

Pharmacovigilance and safety oversight

Activities aimed at detecting, evaluating, understanding and preventing the side effects of medications, which are carried out to improve patient care and safety. Reliable and balanced information supports public health by allowing effective assessment of the risk-benefit profile of a medicine.4


  1. The Therapeutic Goods Act of 1989. Optimising public health and safety, and building community trust in the therapeutic goods regulatory framework. [Current with Therapeutic Goods Amendment (2022 Measures No. 1) Act 2023].
  2. The Therapeutic Goods Administration Compliance Management Information on how the TGA approaches and manages compliance with therapeutic goods regulation in Australia.
  3. Australian Register of Therapeutic Goods (ARTG) Product Information. A Product Information document (PI) provides health professionals with a summary of the scientific information relevant to the safe and effective use of a prescription medicine, some non-prescription medicines and some biologicals.
  4. (2020). World Health Organization - Pharmacovigilance. [online] Available at:  . Access: May 2021.