Products regulated as biologicals

2 July 2018

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.
Diagram showing products regulated as biologicals

Products that fall under this definition can be:

Goods excluded from regulation by the TGA

Goods excluded from regulation as therapeutic goods are listed in the Therapeutic Goods (Human Cells, Tissues and Organs) Determination 2018 and are not regulated by the TGA. Products comprising, containing or derived from human cells or tissues that are excluded include:

  • assisted reproductive technologies (in vitro fertilisation)
  • fresh viable organs
  • fresh haematopoietic progenitor cells (bone marrow transplants)
  • cells and tissues collected from a patient, and manufactured by a registered medical or dental practitioner for therapeutic use in that patient in a hospital.

Further information is also available in Therapeutic Goods (Human Cells, Tissues and Organs) Determination 2018: Guidance.

Regulation of biologicals

Biologicals are regulated by the TGA under the regulatory framework for biologicals.

Products that are biologicals include:

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 comprise, contain or are derived from human cells or tissues 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).

Products that fall under this definition can be: