Do you know what the TGA does and doesn't regulate?

If you have ever taken medicines, received an implant, had a blood transfusion or been given a vaccine, the TGA regulates those products.

The TGA ensures all therapeutic goods available in Australia are safe, high quality, and do what they're supposed to. We do this by making sure the benefits of using a therapeutic good are greater than their risks.

So, what is a ‘therapeutic good’? Therapeutic goods mainly refer to medicines and medical devices. For medicines, they include things like paracetamol and medicines prescribed by a doctor. For medical devices, they include simple products like bandages and surgical masks. It also includes complex technologies like pacemakers.

Did you know that the TGA also regulates some common products you’ll find in your local supermarket or health store? This includes products known as complementary medicines. They include vitamins, some nutritional supplements, and herbal and traditional medicines.

How we regulate complementary medicines varies based on their risk to the community. This depends on the ingredients they contain and the health claims they make. A vitamin tablet that contains low risk ingredients and makes low level health claims will be treated as a low-risk product. For example, vitamin C for maintenance of health and wellbeing. A medicine with higher risk ingredients or more serious health claims will be treated as a higher-risk product. An example of this would be high dose iron tablets used to treat iron deficiency anaemia. The TGA checks that these higher risk products work and are safe before they can be sold. You can read more information on how the TGA regulates complementary medicines.

The TGA also regulates the manufacturing and advertising of therapeutic goods. There are strict standards which must be met to ensure therapeutic goods are produced to the highest quality. The advertising regulations help make sure that Australians aren’t misled or encouraged to use products that may not be good for them.

People often assume the TGA regulates some things it doesn’t. For example, many people think the TGA regulates food, vet medicines and cosmetics. We don’t regulate these goods but there are other government organisations that do.

Some of things the TGA regulates

• medicines available from supermarkets and on pharmacy shelves
• medicines available from behind the pharmacy counter
• medicines prescribed by a doctor or dentist
• complementary medicines, like vitamins, herbal and traditional medicines
• most sunscreens
• medical devices
• products used to test for various diseases or conditions (in vitro diagnostic devices), such as blood tests
• vaccines, blood, blood products, and other biologics
• tissue and cellular products
• sterilants and disinfectants that make claims about microbes such as bacteria and viruses

Some of the things the TGA doesn’t regulate

• Vet medicines regulation (these are regulated by the Australian Pesticides and Veterinary Medicines Authority)
• Food (the standards are set by Food Standards Australia New Zealand and regulated at a state and territory level)
• Health insurance (this is regulated by the Australian Prudential Regulation Authority)
• Cosmetics and chemicals (the Australian Industrial Chemicals Introduction Scheme is responsible for the manufacture and importation of industrial chemicals including ingredients used in cosmetic sunscreens, and the Australian Competition and Consumer Commission is responsible for product safety and labelling standards for consumer products including cosmetics.
• Health practitioners (this is regulated by the Australian Health Practitioner Regulation Agency)

If you’d like to find out more, see the What the TGA regulates and What is not regulated by the TGA pages on our website.