The role of the TGA: Information for health professionals. What is the TGA? We regulate Therapeutic Goods in
Australia, including how they are manufactured and advertised. We are part of the Australian Government Department of Health. What do we regulate? Therapeutic Goods are used for: Preventing, diagnosing, curing, or alleviating a disease, ailment, defect, or injury. Influencing, inhibiting, or modifying a physiological process. Testing the susceptibility of people to a disease or ailment. Influencing, controlling, or preventing conception, or testing for pregnancy. What do we regulate? Therapeutic goods include: prescription medicines, including vaccines, biologicals, blood and tissue products, over-the-counter medicines, complementary medicines, and medical devices, including in vitro
diagnostic devices. We also regulate the manufacturing and advertising of all of these products. For lecture materials on
the different types of therapeutic goods, see our website. How do we regulate? We have systems in place to:

ensure manufacturers meet standards for producing goods, authorise supply, monitor products once they're on the market, and take action if there are problems, and identify illegal activities like counterfeiting and take action to stop these occurring. Did you know? We review manufacturing information for every batch of every vaccine. We test the first five batches of most biological medicines. We perform targeted investigations of medicines for suspected non-compliance. We seek advice from experts on our advisory committees, and we test devices for sterility and when they have been involved in adverse events. How can I tell if the medicine is regulated by the TGA? Lower risk medicines such as vitamins or herbal supplements have an AUST-L number on the label. Higher risk medicines such as prescription medicines or painkillers have an AUST-R number on the label. These medicines are tested for efficacy. Therapeutic goods must be entered on the Australian Register of Therapeutic Goods, or ARTG, before they can be lawfully supplied in Australia.

unless there is an exemption. Search for the AUST-L number, AUST-R number, or product name on the ARTG on our website to find out more about the products you're prescribing. Before approving goods for supply, we weigh the benefits and the risks involved with their use. Just as you consider the benefits and risks of the treatment you recommend to an individual patient, we assess the benefits and risks associated with particular goods for the population before authorizing them for supply. Our work is ongoing. It doesn't stop when a product reaches the market; it continues over the life cycle of every therapeutic good. We only regulate therapeutic goods. Other government agencies regulate veterinary medicines, health professionals, health insurance, food regulation, and cosmetic and chemical standards. We don't research and develop new therapeutic goods, provide clinical advice to individuals, consider cost-effectiveness or recommend one product over another, or make decisions about the subsidy of therapeutic goods. The Pharmaceutical Benefits Scheme

and other areas of government have this responsibility. We need you to report problems to us. You or your patient can report adverse events involving medicines, including vaccines, or medical devices, problems arising during manufacture, storage, or handling, or suspected counterfeit medicines or medical devices. How can you stay up to date with TGA information? We provide email subscription services to notify subscribers when new information is published on our website. You can find out more by visiting www.tga.gov.au or calling 1800 020 653.