About biologicals
Biologicals are products made from, or containing, human cells or human tissues. They also include products containing animal cells, tissues or organs. They are used for purposes like diagnosis, treatment, and prevention of disease.
Most biologicals must be included in the Australian Register of Therapeutic Goods (ARTG) to be legally supplied in Australia. We assess them based on their intended use for quality, safety, and effectiveness.
For a product to meet our definition of a biological, it must be:
a thing made from, or that contains, human cells or human tissues, and that is used to:
treat or prevent disease, ailment, defect or injury
diagnose a condition of a person
alter the physiological processes of a person
test the susceptibility of a person to disease
replace or modify a person's body parts
faecal microbiota transplant products
a thing that comprises or contains live animal cells, tissues or organs.
Although they come from biological sources, advanced therapies, blood and blood components, and biological medicines are regulated as prescription medicines.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to biologicals. You may also have to meet obligations that apply to all products.
