Products regulated as biologicals
Biologicals are defined in Part 3-2A of the Therapeutic Goods Act 1989 (the Act) as a thing made from, or that contains, human cells or human tissues, or live animal cells, tissues or organs and that is used to:
- treat or prevent disease, ailment, defect or injury
- diagnose a condition of a person
- alter the physiological processes of a person
- test the susceptibility of a person to disease
- replace or modify a person’s body parts.
Products that fall under this definition can be:
- not regulated as therapeutic goods (excluded)
- regulated as biologicals under the biologicals regulatory framework
- regulated as therapeutic goods, but not as biologicals.
Goods excluded from regulation by the TGA
- assisted reproductive technologies (in vitro fertilisation)
- fresh viable organs
- fresh haematopoietic progenitor cells (bone marrow transplants)
- cells and tissues made by a medical practitioner for a single patient under the care of that medical practitioner.
Further information is also available in Excluded Goods Order No. 1 of 2011: Guideline for Items 4(o), 4(p), 4(q) and 4(r).
Regulation of biologicals
Biologicals are regulated by the TGA under the regulatory framework for biologicals.
Products that are biologicals include:
- human stem cells
- tissue-based products (skin, bone, ocular, cardiovascular)
- cell-based products (genetically modified, in vitro cell expansion or depletion)
- combined cell and tissue products (collagen matrices for localised cell delivery).
- products that comprise or contain live animal cells, tissues or organs.
Further information on the scope of products that are regulated as biologicals can be found in Section 1.1 of the Australian Regulatory Guidelines for Biologicals.
In the future, changes may be made to the scope of therapeutic goods regulated as biologicals, provided the need for regulatory oversight can be demonstrated and that there is clear policy direction to do so.
Goods regulated as therapeutic goods but not as biologicals
Some products of human origin are regulated by the TGA as therapeutic goods, but not as biologicals. The legislation allows the Secretary to declare specific cell-based therapeutic goods to either be or not be biologicals.
Goods declared not to be biologicals - in the Therapeutic Goods (Things that are not Biologicals) Determination No.1 of 2011 - include:
- biological prescription medicines (vaccines, plasma derivatives, recombinant products)
- labile blood and blood components
- haematopoietic progenitor cells used for haematopoietic reconstitution (non-fresh transplants).