How therapeutic goods are regulated in Australia

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).

On this page: Regulation overview | Therapeutic goods and risk | Therapeutic Goods Administration (TGA)

Regulation overview

• What are 'therapeutic goods'?
  Many of us use medicines or medical devices in our daily lives
• Overview of supplying therapeutic goods in Australia
  A summary of supplying therapeutic goods in Australia
• Role of the sponsor
  The sponsor of a therapeutic good is the person or company responsible for applying to the TGA to have their therapeutic good entered in the Australian Register of Therapeutic Goods
• Medicines and TGA classifications
  Australia has a two-tiered system for the regulation of medicines, including complementary medicines
• Regulatory affairs consultants
  Regulatory affairs consultants offer services, including advice and assistance, in relation to regulatory requirements

Therapeutic goods and risk

• Product regulation according to risk
  Overview of the way the TGA considers risks and benefits during the evaluation and post-market monitoring of products
• The TGA's risk management approach
  The TGA adopts a risk management approach to regulating therapeutic goods

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