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Products that are regulated as biologicals include, but are not limited to:
- tissue-based products (skin, bone, ocular, cardiovascular, amnion)
- cell-based products (genetically modified, in vitro cell expansion or depletion)
- immunotherapy products containing human cells
- combination products (e.g. cell therapy and medical device)
- products that comprise or contain live animal cells, tissues or organs (e.g. pancreatic islet cells isolated from pigs)
- autologous human cells and tissue products (including stem cells)
- faecal microbiota transplant (FMT) products (a thing that comprises, contains or is derived from human stool).
Even though your product may meet the definition of a biological, it may not be regulated as a biological.
If you need further guidance, consider whether you need a pre-submission meeting. See Pre-submission meetings with TGA.