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We are Australia's government authority responsible for evaluating, assessing and monitoring products that are defined as therapeutic goods. We regulate medicines, medical devices and biologicals to help Australians stay healthy and safe.
The Therapeutic Goods Administration (TGA) is Australia's regulatory authority for therapeutic goods.
In Australia, medical products are regulated by the TGA and, for controlled drugs such as cannabis, by the Office of Drug Control (ODC). Together, the TGA and ODC form the Health Products Regulation Group within the Department of Health and Aged Care.
Find out about the types of health products that we assess and monitor, as well as how to access products that are not on the Australian Register of Therapeutic Goods. Information about how to supply, manufacture or advertise therapeutic goods can be found at How we regulate.
TGA Laboratories test therapeutic goods for quality. A risk-based process is applied to determine how products are tested. Samples for testing are obtained from manufacturers, wholesalers, chemists, hospitals, retail outlets or the general public. On average, around 2000 samples of products are tested each year.
Product testing and investigations. TGA Laboratories test therapeutic goods for quality. A risk-based process is applied to determine how products are tested. Samples for testing are obtained from manufacturers, wholesalers, chemists, hospitals, retail outlets or the general public.
provide flexibility to investigate and test therapeutic goods in response to urgent public health and safety concerns. target selected goods for testing to verify they meet the required quality as defined by legislation, official standards or agreed specifications.
Therapeutic goods 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. How therapeutic goods are regulated in Australia.
Jun 24, 2024 · The Therapeutic Goods Administration (TGA) is Australia's regulatory authority for therapeutic goods such as medicines, medical devices, and diagnostic tests. Phone line hours are Monday to Friday 9 am to 5 pm (AEST, excluding public holidays).
The TGA assesses therapeutic goods to help ensure they are safe and effective before approving them for use in Australia. The TGA has a risk-based approach, which means higher-risk therapeutic goods undergo more extensive assessment than lower-risk therapeutic goods.
