Therapeutic Goods Administration (TGA)

What is the TGA? The Therapeutic Goods Administration (TGA) is Australia’s federal regulatory authority responsible for overseeing therapeutic goods. These include prescription and over-the-counter medicines, vaccines, biologicals, medical devices, sunscreens, vitamins and minerals, blood and blood products, and certain diagnostic tests. The TGA functions within the Department of Health and Aged Care and operates under the Therapeutic Goods Act 1989, which mandates that most therapeutic products must be registered, listed, or included in the Australian Register of Therapeutic Goods (ARTG) before they can be supplied, imported, exported, or manufactured in Australia. What does the TGA do? The TGA conducts comprehensive oversight across all stages of a therapeutic product’s lifecycle. It evaluates and assesses products pre-market to establish safety, quality, and efficacy before granting inclusion in the ARTG. Following approval, the TGA monitors the market through adverse event surveillance, recalls, safety alerts, and compliance inspections. It also regulates manufacturing practices, enforces advertising standards, and manages the scheduling of medicines and poisons via the Poisons Standard (SUSMP). Through this risk‑based regulatory framework, the TGA ensures that therapeutic goods remain reliable and safe for public use.