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Who we are & what we do

The Therapeutic Goods Administration is part of the Australian Government Department of Health and Ageing. The TGA's overall purpose is to protect public health and safety by regulating therapeutic goods that are supplied either imported or manufactured, or exported from Australia.

Therapeutic goods include medicines, medical devices and human blood, blood products and tissues.

At the same time the TGA aims to ensure that the Australian community has access, within a reasonable timeframe, to new therapeutic goods.

  • What the TGA regulates
    The TGA is responsible for ensuring that therapeutic goods available for supply in Australia are safe and fit for their intended purpose.
  • 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; and 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
  • Enforceable undertakings
    A person (including a company) who believes they have, or are likely to have breached an offence or civil penalty provision in the TGA legislation, can apply to enter into a written undertaking as an alternative to court action being commenced by the TGA
  • 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
  • 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
  • TGA internal review guideline
    This guideline provides information on the operation of internal review in TGA, and guidance on how to apply under section 60 of the Therapeutic Goods Act 1989, to have an initial decision of a TGA delegate reviewed
  • 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.

Web page last updated: Wednesday, 29 August 2012

URL: http://www.tga.gov.au/about/tga-who-we-are.htm

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