Common questions or information that Australian manufacturers need to know about TGA approved goods

Australian manufacturers are seeking ways they can assist with COVID-19 equipment and supply needs. For many, this is the first time that they have sought to work in the medical sector, and they would like a greater understanding of the regulations around the supply of therapeutic goods in Australia. This document seeks to provide a summary of some publicly available information that they may like to consider.

The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health and is responsible for regulating therapeutic goods including prescription medicines, vaccines, sunscreens, vitamins and minerals, medical devices, blood and blood products ( Almost any product for which therapeutic claims are made must be entered in the Australian Register of Therapeutic Goods (ARTG) before it can be supplied in Australia ( ).

While there is a lot of information on the TGA website, it is often targeted to those who understand the regulatory framework. Due to this, the TGA is now working to develop some easy to understand non-technical / regulatory fact sheets to assist manufacturers who may not be familiar with therapeutic goods regulations. In the meantime, please find some targeted information below, which is derived directly from the TGA website.

* Please note, that the TGA website is being updated continuously, particularly during the current pandemic, so please check the TGA website links provided, for the most current information.