Regulation basics

The Australian community expects therapeutic goods in the marketplace to be safe, of high quality and of a standard at least equal to that of comparable countries.

The TGA is responsible for ensuring that therapeutic goods available for supply in Australia are safe and fit for their intended purpose. These include goods Australians rely on every day, such as vitamin pills and bandaids, through to goods used to treat serious conditions, such as prescription medicines, vaccines, blood products and surgical implants.

  • How therapeutic goods are regulated in Australia
    The regulation of therapeutic goods in Australia is designed to ensure the quality, safety, efficacy and performance of medicines and medical devices.
  • Australian Register of Therapeutic Goods
    The Australian Register of Therapeutic Goods is a computer database of therapeutic goods. Therapeutic goods are divided broadly into two classes - medicines and medical devices.
  • Legislation & legislative instruments
    Information about and links to Australian therapeutic goods legislation
  • Advertising therapeutic goods
    Advertisements for therapeutic goods in Australia are subject to the requirements of the Therapeutic Goods Act and Regulations, the Trade Practices Act and other relevant laws.
  • Labelling & packaging
    Labelling and packaging is part of the Australian system of regulating medicines and medical devices
  • Import & export
    Information about importing and exporting therapeutic goods for commercial purposes
  • Clinical trials
    These documents describe the regulations for allowing patients access to unapproved medicines or medical devices by participation in a clinical trial.
  • Cosmetics
    The TGA only assesses cosmetic products that make therapeutic claims
  • Regulatory reforms
    Information about the TGA's program of regulatory reforms
  • Safety information for industry
    The Australian community expects therapeutic goods in the marketplace to be safe, of high quality and of a standard at least equal to that of comparable countries

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