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TGA – Therapeutic Goods Administration

The TGA is a part of the Australian Government Department of Health, and is responsible for regulating the import, supply, manufacture, export and advertising of therapeutic goods.

This includes:

  • medicines (prescription, over the counter and complementary medicines)
  • medical devices
  • in vitro diagnostic tests
  • vaccines
  • biologicals (such as human cell- and tissue-derived products)
  • blood and blood products
  • other therapeutic goods including sunscreens, sterilants and disinfectants, tampons and menstrual cups.

The TGA does this by administering the Therapeutic Goods Act 1989 (the Act), which applies a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality and safety. When required by the Act, the TGA will also ensure that efficacy or performance standards are acceptable.

The TGA monitors the ongoing risks and benefits of therapeutic goods once they are authorised for use, and is able to take action if the benefits are not realised or additional risks become apparent. Possible regulatory actions vary from minimal intervention, such as changes to labelling, to withdrawing the therapeutic good from the market.

The role of the TGA

Watch this video to learn more about what the TGA do.

Benefits versus risks approach to regulating therapeutic goods

Watch this video to learn how the TGA ensure that the benefit of therapeutic goods outweigh any known risks.

Last reviewed: August 2014

Information from this partner

Found 82 results

Educational materials | Therapeutic Goods Administration (TGA)

Added GP waiting room videos and Travelling with medicines and medical devices

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Reporting adverse events | Therapeutic Goods Administration (TGA)

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Report a side effect of a medicine | Therapeutic Goods Administration (TGA)

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Nanotechnology and therapeutic products | Therapeutic Goods Administration (TGA)

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Database of Adverse Event Notifications (DAEN) | Therapeutic Goods Administration (TGA)

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Registered and listed medicines | Therapeutic Goods Administration (TGA)

The AUST L or AUST R number on your medicine package shows that the TGA has evaluated the product and it is on the A

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Consumer educational materials | Therapeutic Goods Administration (TGA)

Whether you are a patient with a chronic condition or a healthy adult regularly taking a multivitamin, you are a consumer of

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Legislation & legislative instruments | Therapeutic Goods Administration (TGA)

The Therapeutic Goods Act, Regulations and Orders set out the requirements for inclusion of therapeutic goods in the Australian Register

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Monitoring communications | Therapeutic Goods Administration (TGA)

The TGA emphasises that patients should NOT stop using a medicine or medical device subject to a monitoring commu

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Scheduling basics | Therapeutic Goods Administration (TGA)

Scheduling is a national classification system that controls how medicines and poisons are made available to the public.

Read more on TGA – Therapeutic Goods Administration website

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