TGA Regulation of Therapeutic Goods in Australia

The TGA regulates therapeutic goods in Australia, including manufacturing, advertising, and monitoring for compliance and safety.

### Understanding the Role of the Therapeutic Goods Administration (TGA) in Australia
* 🏥 The TGA is the regulatory body responsible for overseeing and monitoring therapeutic goods in Australia, including **prescription medicines, over-the-counter medicines, complementary medicines, vaccines, biologicals, blood and tissue products, and medical devices**.
* ⚖ The TGA ensures that these products meet specific standards for **manufacturing, advertising, and supply**, as well as monitoring their **safety and effectiveness** once they are on the market.
* 🔍 To determine if a medicine is regulated by the TGA, health professionals can look for an **AUST-L number** on the label for lower risk medicines, and an **AUST-R number** for higher risk medicines, which are **rigorously tested for efficacy**.
* 🔬 The TGA reviews manufacturing information for **every batch of vaccines**, tests the **first five batches** of most biological medicines, and conducts **targeted investigations of medicines for suspected non-compliance**.
* 📝 Before approving a therapeutic good for supply, the TGA evaluates the **benefits and risks associated with its use**, similar to how a healthcare professional considers the **benefits and risks of a treatment for an individual patient**.
* 📊 The TGA's work is ongoing and continues over the life cycle of every therapeutic good, **not stopping once a product reaches the market**.
* 📞 Health professionals and patients are encouraged to report any problems or adverse events related to therapeutic goods to the **TGA**.
* 🔗 To stay informed about TGA regulations and updates, health professionals can **subscribe to email notifications on the TGA website** or **contact the TGA directly for more information**.

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.

The role of the TGA: Information for health professionals

TGA Australia

The Role of the TGA in Regulating Therapeutic Goods in Australia

The TGA, part of the Australian Government Department of Health, regulates the manufacturing and advertising of a wide range of therapeutic goods, including medicines, vaccines, and medical devices.

They ensure that manufacturers meet production standards, monitor products on the market, and take action against any problems or illegal activities.

The TGA also reviews manufacturing information for every vaccine batch, tests biological medicines, and uses labeling to distinguish between lower and higher risk medicines.

Regulatory Responsibilities for Therapeutic Goods

The regulatory body weighs the benefits and risks of therapeutic goods before approving them for supply.

Their work continues throughout the life cycle of each product, focusing solely on therapeutic goods and not being involved in research, clinical advice, or cost-effectiveness considerations.

Other agencies are responsible for regulating different aspects of the healthcare and pharmaceutical industry, such as veterinary medicines, health professionals, and the subsidy of therapeutic goods.

Reporting Adverse Events and Staying Informed with the TGA

The TGA is responsible for handling reports of problems with medicines, vaccines, and medical devices.

They offer email subscription services and a website to help people stay updated on TGA information.

au or call 1800 020 653 for more details.