Medicines regulation and clinical trials

Medicines regulation

In Australia, all medicines must be approved for sale by the Australian Government’s Therapeutic Goods Administration (TGA). Companies can also apply for prescription medicines to be subsidised under the Pharmaceutical Benefits Scheme (PBS). If a medicine is subsidised under the PBS, the Government pays part of the cost.

All medicines sold or PBS listed must meet standards of quality, safety and effectiveness. The TGA also decides how freely it should be available — for example, on prescription only, pharmacy only or sold in supermarkets. Read more about the different categories of medicines, or schedule levels.

Clinical trials

Some of the strongest evidence about the effects of medicines comes from clinical trials, which are research studies to find out how well medicines work and what their side effects are. Read more about what clinical trials tell us, and why they are important. Clinical trials also give us information about a medicine’s side effects.

For more information