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

1. excluded from TGA regulation
2. regulated as a therapeutic good, but not as a biological, or
3. regulated as a biological.