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How therapeutic goods are regulated in Australia

Related information

General information about how therapeutic goods are regulated in Australia. More detailed information is available for each of the product areas (see the left navigation).

Regulation overview

Therapeutic goods and risk

Therapeutic Goods Administration (TGA)

  • 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 approach to disclosure of commercially confidential information (CCI)
    The TGA has obligations under the Protective Security Policy Framework to ensure it develops, documents, implements and reviews appropriate security measures to protect information from unauthorised use or accidental modification, loss or release.
  • Reconsideration of reviewable initial decisions
    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