Basics of therapeutic goods regulation

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9 June 2017

The role of the TGA

The TGA regulates and monitors therapeutic goods through various processes.

  • We authorise the commercial supply of therapeutic goods for use in Australia through the Australian Register of Therapeutic Goods (ARTG), an electronic register of therapeutic goods that can be lawfully supplied in Australia.
  • We monitor the safety of therapeutic goods using information from various sources, including the community, healthcare providers, overseas regulators and the ARTG entry holders ('sponsors') and manufacturers as a part of their reporting obligations.
  • We authorise Australian manufacturers to ensure products made in Australia are of an appropriate standard.

The TGA is required to recover its costs through fees and charges for all activities that fall within the scope of the Therapeutic Goods Act 1989, including the TGA's public health responsibilities. For more information about the TGA see:

How are therapeutic goods regulated?

The approach to regulation for therapeutic goods depends on the level of risk to public health and/or safety of the product. For example, therapeutic goods that pose a higher risk of adverse events or are used for more serious diseases (such as prescription medicines) are more tightly regulated and monitored than those that pose a lower risk (such as herbal supplements).

When a product is in a higher risk category, we:

  • regulate it more carefully using more rigorous assessment processes
  • require more data or information, especially to demonstrate quality, safety, efficacy and performance
  • have higher fees for manufacturers and sponsors, especially where the therapeutic good might require more monitoring or needs more scrutiny

If a product meets all regulation requirements, it can be added to the ARTG. However, there are special circumstances where therapeutic goods not on the ARTG can be lawfully supplied (such as for clinical trials). This information is relevant to researchers who are developing new innovative therapeutic products. For more information: Accessing unapproved products.

Once you have determined what type of therapeutic good you have, you will need to determine the risk level. For more information:

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