ARTG (Australian Register of Therapeutic Goods)

Definition

The Australian Register of Therapeutic Goods (ARTG) is a comprehensive, publicly accessible database maintained by the TGA that lists all therapeutic goods approved for supply in Australia. For each registered product, the ARTG includes details such as the active ingredient, approved indications (approved uses), approved dosage forms and strengths, packaging configuration, and any restrictions or conditions on supply. The ARTG distinguishes between medicines registered for therapeutic use and medical devices, and it includes information about whether a product is available on prescription, over-the-counter, or through restricted supply schemes. Researchers, healthcare providers, and the public can search the ARTG to verify whether a particular product is legally approved in Australia and to understand its approved uses. The database is updated regularly as new products are approved and as existing approvals are modified or cancelled.

An entry in the ARTG indicates that the TGA has accepted that the product meets required standards for quality, safety, and efficacy (or performance, for medical devices). However, ARTG registration does not mean a product is necessarily available in Australian pharmacies or that it is covered by health insurance; availability and pricing depend on other factors. When a product is not registered in the ARTG, it is considered an unregistered therapeutic good in Australia and cannot be legally supplied except through specific exemptions such as the Special Access Scheme.

Pharmaceutical companies and manufacturers submit applications to register products in the ARTG through established pathways (standard registration, streamlined registration, or conditional approval). The TGA's registration decision is based on evaluation of the submitted dossier, which includes quality, nonclinical, and clinical data. Once approved, companies must maintain compliance with ARTG conditions throughout the product's life cycle, including reporting of adverse events, regular safety reviews, and adherence to manufacturing standards.