From: www.tga.gov.au
The Australian Regulatory Guidelines for Biologicals (ARGB):
- provides information on the supply and use of human cell and tissue-based therapeutic goods, and live animal cells, tissues and organs
- explains the legislative requirements outlined in the regulatory framework for biologicals, including specific biological standards.
Pathways for supply of biologicals
If you have a product that meets our definition of a biological, Pathways for supply of biologicals will help you understand how your biological can be supplied.
