Basics of therapeutic goods regulation
Is my product a therapeutic good?
Therapeutic goods are products for therapeutic use; that is, they are intended to be used for human health.
For a full definition of therapeutic goods, go to Section 3 of the Therapeutic Goods Act 1989.
Therapeutic use means use in or in connection with:
- preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons; or
- influencing, inhibiting or modifying a physiological process in persons; or
- testing the susceptibility of persons to a disease or ailment; or
- influencing, controlling or preventing conception in persons; or
- testing for pregnancy in persons; or
- the replacement or modification of parts of the anatomy in persons.
If your product meets the above definition and criteria, you are required to engage with the TGA.
Therapeutic goods fall under three different 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, apparatuses and appliances, such as pacemakers and sterile bandages)
Therapeutic goods can comprise a broad range of things, such as bandages, pregnancy testing kits, herbal remedies, tissue grafts and paracetamol. The TGA also regulates what are known as Other Therapeutic Goods (OTGs), which include items such as tampons and disinfectants.