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How therapeutic goods are regulated in Australia

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This topic explains in general terms how therapeutic goods are regulated in Australia. More detailed information is available under each of the product areas (see the left navigation).
  • Medicines and TGA classifications
    Within the regulatory framework, medicines are classified into several categories: Registered medicines, Listed medicines, Complementary medicines
  • What are 'therapeutic goods'?
    Many of us use medicines or medical devices in our daily lives
  • How the TGA regulates
    The TGA regulates therapeutic goods through: pre-market assessment; post-market monitoring and enforcement of standards; and licensing of Australian manufacturers and verifying overseas manufacturers' compliance with the same standards as their Australian counterparts.
  • Role of the sponsor
    The sponsor of a medicine is the person or company responsible for applying to the TGA to have their medicine included in the Australian Register of Therapeutic Goods
  • The TGA's risk management approach
    In undertaking its regulatory roles, the TGA adopts a risk management approach by identifying, analysing, evaluating and treating the risks posed by medicines, medical devices, chemicals, gene technology, blood, blood products and tissues.

Web page last updated: Tuesday, 7 May 2013

URL: http://www.tga.gov.au/industry/basics-regulation.htm

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