Enacted by the Commonwealth Parliament and administered by the Therapeutic Goods Administration (TGA), the Act defines what constitutes a therapeutic good, sets out the conditions under which goods may be included in the Australian Register of Therapeutic Goods (ARTG), and specifies the offences and civil penalty provisions that apply to unapproved or non-compliant goods. It sits at the apex of a suite of related instruments, including the Therapeutic Goods Regulations 1990 and the Poisons Standard (formally the Standard for the Uniform Scheduling of Medicines and Poisons).
The Act establishes several access pathways for goods not yet listed or registered on the ARTG, most notably the Special Access Scheme (SAS) and the Authorised Prescriber (AP) scheme. These pathways allow medical practitioners to supply unapproved therapeutic goods to patients in defined circumstances, subject to TGA oversight. Prescription medicines, controlled drugs, and Schedule 8 and Schedule 9 substances listed under the Poisons Standard are subject to additional layers of control under this legislative framework.
Amendments to the Act over time have expanded TGA powers in areas including advertising enforcement, post-market surveillance, and the regulation of biologicals and medical devices. A significant 2023 amendment rescheduled certain substances , including psilocybine and 3,4-methylenedioxymethamphetamine (MDMA) , from Schedule 9 (Prohibited Substance) to Schedule 8 (Controlled Drug) for limited therapeutic use by Authorised Prescribers, illustrating how the Act intersects with scheduling decisions made under the Poisons Standard.
Non-compliance with the Act can attract substantial civil and criminal penalties. The TGA publishes enforcement actions, recalls, and alerts on its website. Sponsors, manufacturers, and importers operating in Australia are required to understand their obligations under the Act and its subordinate instruments before placing any therapeutic good on the Australian market.
Sources: