What the TGA regulates

The TGA is responsible for ensuring that therapeutic goods available for supply in Australia are safe and fit for their intended purpose. These include goods Australians rely on every day, such as vitamin tablets and sunscreens, through to goods used to treat serious conditions, such as prescription medicines, vaccines, blood products and surgical implants.

The TGA regulates the supply of:

  • medicines prescribed by a doctor or dentist
  • medicines available from behind the pharmacy counter
  • medicines available in the general pharmacy
  • medicines available from supermarkets
  • complementary medicines, these include vitamins, herbal and traditional medicines
  • medical devices, from simple devices like bandages to complex technologies like heart pacemakers
  • products used to test for various diseases or conditions (in vitro diagnostic devices), such as blood tests; and
  • vaccines, blood products, and other biologics.

and the manufacturing and advertising of these products.

Regulating medicines

The regulation of medicines includes the following features:

  • classifying the medicine based on different levels of risk to the person taking them
  • implementing appropriate regulatory controls for the manufacturing processes of medicines
  • Medicines assessed as having a higher level of risk (prescription medicines, some non-prescription medicines) are evaluated for quality, safety and efficacy
  • Ingredients in medicines with a lower risk (medicines purchased over the counter, such as complementary medicines) are assessed for quality and safety
  • Medicines determined to be available for lawful supply by the Therapeutic Goods Administration can be identified by either an AUST R number or an AUST L number on the outer packaging. Please note, there are a small number of medicines that are exempt and do not require this information on the label
  • Once available for supply, medicines are subject to monitoring by the TGA. This monitoring includes a comprehensive adverse event reporting programme.

Regulating medical devices

The regulation of medical devices includes:

  • classifying the medical device based on different levels of risk to the user
  • assessing compliance with a set of internationally agreed essential principles for their quality, safety and performance
  • implementing appropriate regulatory controls for the manufacturing processes of medical devices
  • including the medical device in the Australian Register of Therapeutic Goods
  • Once available for supply, medical devices are subject to monitoring by the TGA. This monitoring includes a comprehensive adverse event reporting programme.

Other therapeutic goods regulated by the TGA

The TGA also applies a risk management approach to the regulation of:

  • In vitro diagnostic medical devices (IVDs)
  • blood
  • blood components
  • plasma derivatives
  • tissue and cellular products
  • tissue and cell based derivatives
  • sterilants and disinfectants

Further information on the regulation of these products is available from this website.