Confirm your product is regulated as a biological
Confirm your product is regulated as a biological.
Even though your product may meet the definition of a biological, it may not be regulated as a biological.
How we define biologicals
For your 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
How we regulate biologicals
We apply regulation to products that meet the definition of a biological in three ways.
Biologicals can be
- excluded from TGA regulation
- regulated as a therapeutic good, but not as a biological, or
regulated as a biological.