The TGA's risk management approach

12 September 2011

The Australian community has an expectation that therapeutic goods are safe and of high quality, to a standard equal to that in comparable countries. The objective of the Therapeutic Goods Act 1989 (the TG Act) is to provide a national framework for the regulation of therapeutic goods in Australia, so as to ensure their quality, safety, efficacy and timely availability.

The Therapeutic Goods Administration (TGA), as part of the Australian Government Department of Health and Ageing, has responsibility for administering the TG Act. Essentially, any product for which therapeutic claims are made must be included in the Australian Register of Therapeutic Goods (ARTG) before it can be supplied in Australia. The exceptions to this requirement are if a product is subject to one of the limited exemptions set out in the legislation.

The TGA adopts a risk management approach to regulating therapeutic goods.

In essence, this means that the TGA:

  • identifies, assesses and evaluates the risks posed by therapeutic goods;
  • applies any measures necessary for treating the risks posed; and
  • monitors and reviews the risks over time.

The purpose of this document is to describe the broad risk management approach adopted by the TGA. It is intended that this document will be updated as the regulatory systems changes through future legislative amendments.

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