Healthdirect Free Australian health advice you can count on.

Medical problem? Call 1800 022 222. If you need urgent medical help, call triple zero immediately

healthdirect Australia is a free service where you can talk to a nurse or doctor who can help you know what to do.

beginning of content

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.

Recommended links

Last reviewed: September 2018

Information from this partner

Found 95 results

Educational materials | Therapeutic Goods Administration (TGA)

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

Read more on TGA – Therapeutic Goods Administration website

Reporting adverse events | Therapeutic Goods Administration (TGA)

Read more on TGA – Therapeutic Goods Administration website

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

Read more on TGA – Therapeutic Goods Administration website

Nanotechnology and therapeutic products | Therapeutic Goods Administration (TGA)

Read more on TGA – Therapeutic Goods Administration website

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

Read more on TGA – Therapeutic Goods Administration website

Prescribing medicines in pregnancy database | Therapeutic Goods Administration (TGA)

Read more on TGA – Therapeutic Goods Administration website

Personal importation scheme | Therapeutic Goods Administration (TGA)

Individuals can legally import most therapeutic goods for personal use under the Personal Importation Scheme.

Read more on TGA – Therapeutic Goods Administration website

Medicines safety | Therapeutic Goods Administration (TGA)

General information about the safety of medicines and how safety is monitored.

Read more on TGA – Therapeutic Goods Administration website

Open consultations & reviews | Therapeutic Goods Administration (TGA)

[view:consultations=open_consultations]

Read more on TGA – Therapeutic Goods Administration website

TGA basics | Therapeutic Goods Administration (TGA)

The Therapeutic Goods Administration (TGA) is part of the Australia

Read more on TGA – Therapeutic Goods Administration website

Healthdirect 24hr 7 days a week hotline

24 hour health advice you can count on

1800 022 222

Government Accredited with over 140 information partners

We are a government-funded service, providing quality, approved health information and advice

Australian Government, health department logo ACT Government logo New South Wales government, health department logo Northen Territory Government logo Government of South Australia, health department logo Tasmanian government logo Government of Western Australia, health department logo