How therapeutic goods are regulated in Australia

This topic explains in general terms how therapeutic goods are regulated in Australia. More detailed information is available under each of the product areas (see the left navigation).

Medicines and TGA classifications
Within the regulatory framework, medicines are classified into several categories: Registered medicines, Listed medicines, Complementary medicines
What are 'therapeutic goods'?
Many of us use medicines or medical devices in our daily lives
How the TGA regulates
The TGA regulates therapeutic goods through: pre-market assessment; post-market monitoring and enforcement of standards; and licensing of Australian manufacturers and verifying overseas manufacturers' compliance with the same standards as their Australian counterparts.
Role of the sponsor
The sponsor of a medicine is the person or company responsible for applying to the TGA to have their medicine included in the Australian Register of Therapeutic Goods
The TGA's risk management approach
In undertaking its regulatory roles, the TGA adopts a risk management approach by identifying, analysing, evaluating and treating the risks posed by medicines, medical devices, chemicals, gene technology, blood, blood products and tissues.

Web page last updated: Monday, 28 February 2011

URL: http://www.tga.gov.au/industry/basics-regulation.htm

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