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Who we are & what we do

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As part of the Department of Health, the TGA safeguards and enhances the health of the Australian community through effective and timely regulation of therapeutic goods.

  • What the TGA regulates
    The TGA is responsible for regulating the supply, import, export, manufacturing and advertising of therapeutic goods
  • What the TGA doesn't do
    Information about what the TGA doesn't do
  • How the TGA regulates
    The TGA regulates therapeutic goods through: pre-market assessment, post-market monitoring and enforcement of standards, licensing of Australian manufacturers and verifying overseas manufacturers' compliance with the same standards as their Australian counterparts
  • TGA regulatory framework
    The TGA takes a risk-based approach to regulation
  • Therapeutic product vigilance
    TGA's approach to therapeutic product vigilance is to continually monitor and evaluate the safety and efficacy (performance) profile of therapeutic products and to manage any risks associated with individual products
  • Treatment of information provided to the TGA
    Information that is provided to TGA, such as personal, business or commercially confidential information, is treated as official information.
  • About the work of the TGA - a risk management approach
    Risk information is used by the TGA when deciding whether to approve a medication for supply and the conditions that might be imposed on that approval
  • A history of therapeutic goods regulation in Australia
    The TGA today represents the product of a long history of evolution of therapeutic products regulation in Australia.