Biologicals

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.