Biological products regulated as a therapeutic good, but not as a biological
Find out if your biological product is regulated as a different type of therapeutic good.
Products regulated as a therapeutic good, but not as a biological
Some products, even though they meet the definition of a biological are:
- regulated by us as therapeutic goods
- not regulated as biologicals
The Secretary can declare specific therapeutic goods to either be or not be biologicals.
Things that are not biologicals
The following goods are declared not to be biologicals:
- biological medicines (regulated as prescription medicines):
- vaccines (that do not contain viable human cells)
- recombinant products
- plasma derived products (or that contain plasma derived products)
- blood and blood components (regulated as medicines under the Therapeutic Goods (Manufacturing Principles) determination)
- Blood means whole blood collected from a single human donor and processed either for transfusion or further manufacturing.
- Blood components means therapeutic components of blood (red cells, white cells, platelets, plasma) that can be prepared by centrifugation, filtration and freezing, but not including haematopoietic progenitor cells.
- haematopoietic progenitor cells (HPC) used for haematopoietic reconstitution (regulated as medicines under the Therapeutic Goods (Manufacturing Principles) determination)
- HPC means self-renewing or multi-potent stem cells, or both, capable of maturation into haematopoietic lineages, lineage-restricted pluripotent progenitor cells, or committed progenitor cells.
- Includes HPC derived from cord blood.
- in vitro diagnostic devices (IVDs)
- samples of human cell or tissue that are solely for diagnostic purposes in the same individual
These are defined in the Therapeutic Goods (Things that are not Biologicals) Determination).
Equipment and materials used for the manufacture of your product
Even though your biological may be excluded from our regulation, equipment and materials used for the manufacture of the product may be therapeutic goods to which therapeutic goods legislation applies and may be subject to regulation by us. For example, IVF solutions are regulated as a medical device.
- Regulation of blood
- Blood and blood components
- Manufacturing blood and blood components
- Forms for the blood and blood components industry
- Guidance 9: Therapeutic goods that contain or are produced from human blood or plasma
- Regulation of platelet-rich plasma (PRP), platelet-rich fibrin (PRF) and conditioned serum
- Intended use: Interpretation of homologous use
- Communication to stakeholders: Remade standards and legislative instruments for human cell and tissue (HCT) products, blood and blood components