About biologicals
Products that are regulated as biologicals include:
- 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 (for example, cell therapy and medical device)
- products that comprise or contain live animal cells, tissues or organs (for example, 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).
For detailed information on how we define and regulate biologicals go to What is regulated as a biological.
More information
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PageUnderstand how we regulate human tissue and cell-derived products and live animal cell, tissues or organs in Australia.
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PageHow we include new biologicals in the Australian Register of Therapeutic Goods (ARTG).
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Accessing unapproved biologicals that are not on the Australian Register of Therapeutic Goods (ARTG)
GuidanceGuidance for people who want to access biologicals that are not included on the Australian Register of Therapeutic Goods (ARTG). -
GuidanceGuidance to explain how the intended use of a biological product influences its classification and exemptions.
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PageUnderstand the potential health risks and legal implications for placenta consumption.
Faecal microbiota transplant
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GuidanceGuidance for sponsors of faecal microbiota transplant (FMT) products, which are regulated as biologicals.
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PageUnderstand how we regulate faecal microbiota transplant (FMT) products.
Latest articles
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Therapeutic Goods (Technical Master File and Type II Plasma Master File - Application Form) Approval 2026
Regulatory decision noticesThis instrument is made under subclause 2(3)(a) of Schedule 5A to the Therapeutic Goods Regulations 1990. -
October 2026 updates to the list of decisions for Australian manufacturers licensed by the TGA
Regulatory decision noticesWe have added our recent decisions to the list of Australian manufacturers licensed by the TGA. -
September 2026 updates to the list of decisions for Australian manufacturers licensed by the TGA
Regulatory decision noticesWe have added our recent decisions to the list of Australian manufacturers licensed by the TGA.
Latest publications
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Corporate reportsRead our business plan 2026-27 to find out about our strategic priorities and activities.
Latest consultations
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ConsultationWe are seeking feedback on proposed changes to improve the Therapeutic Goods Advertising Code.
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ConsultationWe are seeking industry feedback on proposed amendments to strengthen the legal framework governing TMFs for blood and blood components, and PMFs for Type II plasma-derived products.
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ConsultationWe are seeking feedback on whether 19 international scientific guidelines should be adopted.