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.
- Confirm your product is regulated as a biologicalPageConfirm your product is regulated as a biological.
- Application process for supplying a biologicalPageAll biologicals must be classified before they can be included on the Australian Register of Therapeutic Goods (ARTG).
- Submit your application and dossierPageInformation on submitting your application and dossier for biologicals.
- Vary your ARTG entry for a biologicalPageHow to vary the information in your biological Australian Register of Therapeutic Goods (ARTG) entry.
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