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About us

We regulate the safety, effectiveness and quality of therapeutic goods in Australia.

Who we are

We regulate therapeutic goods for safety, efficacy, performance and quality to help protect and improve the health of Australians.

The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health, Disability and Ageing. 

We are Australia's regulatory authority for therapeutic goods such as: 

  • prescription medicines
  • non-prescription medicines
  • vaccines
  • medical devices
  • blood and blood products
  • sunscreens
  • vitamins
  • software and artificial intelligence-based medical devices.

What we do

Our goal is to give Australians access to therapeutic goods that are safe, effective and high quality. Our role includes: 

  • assessing new medicines and medical devices before they can be sold
  • monitoring how they are made, advertised and supplied
  • tracking their safety once they are available to the public and acting if a safety issue is identified
  • providing education, clear advice and information
  • managing compliance including testing products in our laboratories
  • taking action against serious, deliberate and repeated non-compliance with Australia's therapeutic goods legislation.

We maintain the Australian Register of Therapeutic Goods (ARTG) which lists therapeutic goods that can be lawfully supplied in Australia. 

We also provide pathways for access to unapproved goods through clinical trials and special programs.

Our approach

We use a risk-based approach to approve and regulate therapeutic goods.  When making decisions about products, we look at whether the benefits outweigh the risks. We do this by using our clinical expertise and scientific evidence. We aim to balance access to new and established treatments, with ensuring we regulate for safety and quality.

We also monitor therapeutic goods once they are on the market. We act if there is a risk to public health or when products do not meet Australian standards. This includes cancelling a product’s approval, requiring changes to packaging or issuing fines.

Short video about our role

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