How are clinical trials regulated in Queensland?

Clinical trials in Australia are regulated on a number of levels under Commonwealth, state and territory legislation. The TGA is part of the Commonwealth Department of Health and is responsible for regulating medicines and medical devices—much like the Federal Drug Administration (FDA) in the United States.

The TGA oversees the inclusion of medicines and medical devices on the Australian Register of Therapeutic Goods (ARTG).

When medicines or medical devices for human use are imported, manufactured in Australia, supplied by a corporation, supplied interstate or to the Commonwealth or exported they must be included in the ARTG unless exempted.

Unapproved medicines and medical devices supplied in a clinical trial require an exemption under the Clinical Trial Notification Scheme (CTN) or through the Clinical Trial Approval Scheme (CTA).

The TGA has strict compliance standards to ensure Australian products and services meet the highest global standards.

Australian research data is globally recognised, respected and supports international regulatory applications— including the FDA and the European Medicines Agency (EMA). This enables faster market entry and lowers costs.