Therapeutic goods can comprise a broad range of things, such as bandages, pregnancy testing kits, herbal remedies, tissue grafts and paracetamol. They generally fall under three main categories:
- Medicines - including prescription, over-the-counter and complementary medicines, such as paracetamol and echinacea
- Biologicals - something made from or containing human cells or tissues, such as human stem cells or skin
- Medical devices - including instruments, implants and appliances, such as pacemakers and sterile bandages
The TGA also regulates what are known as other therapeutic goods (OTGs), which include items such as tampons and disinfectants.
What makes goods therapeutic?
Therapeutic goods are broadly defined as products for use in humans in connection with:
- preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury
- influencing, inhibiting or modifying a physiological process
- testing the susceptibility of persons to a disease or ailment
- influencing, controlling or preventing conception
- testing for pregnancy.
This includes things that are:
- used as an ingredient or component in the manufacture of therapeutic goods
- used to replace or modify parts of the anatomy
You can find a definition of 'therapeutic goods' in Section 3 of the Therapeutic Goods Act 1989.
The TGA is responsible for evaluating, assessing and monitoring products that are defined as therapeutic goods.
Are all products that make health claims therapeutic goods?
Some products you use make claims about the health effects they have on your body. This does not necessarily mean that they are therapeutic goods. They could be foods, cosmetics or therapeutic goods.
Use the 'Is my product a therapeutic good?' decision tool to help you identify if your product may be a therapeutic good.
Is it a medicine or food?
Sometimes it is unclear whether a product is a medicine or food. Such products are described as being at the Food Medicine Interface. It is important to know whether your product is a medicine or a food because different regulatory requirements apply.
Medicines and other types of therapeutic goods are regulated under the Therapeutic Goods Act, whereas foods are regulated by state and territory food regulatory bodies by reference to the Australia New Zealand Food Standards Code.
Various factors are considered when determining whether a product is a medicine or a food. The way in which a product is presented to consumers may be one of these factors. For example, minced or crushed garlic in a bottle is likely to be a food as there is a tradition of use of garlic as food in that form in Australia. However, if chemicals in the garlic are extracted, concentrated and marketed in a capsule with claims that it can be used to 'relieve cold and flu symptoms', it might be considered a medicine.
It is the responsibility of the manufacturer, importer and supplier to ensure that their products comply with all relevant requirements under the applicable regulatory scheme.
Use the Food-Medicine Interface Guidance Tool to help you determine whether or not your product is likely to be a therapeutic good and which regulatory regime is likely to apply. Note that this tool does not determine whether a product meets all the requirements of the relevant legislation. Before using this tool, we encourage you to familiarise yourself with the basics of Food and medicine regulation.
Is it a therapeutic good or a cosmetic?
One of the main factors in determining whether a product is a cosmetic or a therapeutic good is the claims made about the product. For example, moisturisers that contain a sunscreening agent as a secondary component and have a stated therapeutic purpose (for example, 'May assist in preventing some skin cancers', or ‘relieve symptoms of mild psoriasis’) may be considered therapeutic goods.
Even if a product is intended for marketing as a cosmetic, it may be classified as a therapeutic good. This depends on:
- its ingredients
- the route of administration
- whether therapeutic claims are made on its label or in advertising
Use the 'Is my product a cosmetic?' decision tool on the Australian Industrial Chemicals Introduction Scheme website to help you identify if your product is a cosmetic.
For more information about the regulation of sunscreens, see Understanding the regulation of therapeutic sunscreens (previously the Australian Regulatory Guidelines for Sunscreens).