Biologicals
Find out how we define biologicals and how we regulate them.
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
Latest alerts
- Additional safety protections relating to COVID-19 for faecal microbiota transplant (FMT) productsAdvice for FMT providers on safety protections related to COVID-19
Latest articles
- Stem cell treatments and regulation - a quick guide for consumersCommonly asked questions about stem cells and regulation
- TGA strengthens regulation of stem cell treatmentsNew regulations for stem cell treatments in Australia came into force on 1 July 2019
Events and webinars
Latest publications
- Australian regulatory guidelines for biologicals (ARGB)The standards have been remade and revised guidance published.
- Biologicals application form - a step-by-step guideThis form is used to include a new biological or vary an existing biological on the ARTG
- Faecal Microbiota Transplant (FMT) product regulationAll FMT products are regulated as biologicals