Blood and blood components
Find out how blood and blood components are regulated.
Blood and blood components including haematopoietic progenitor cells and plasma-derived medical products are regulated as prescription 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
- plasma derived products (or that contain plasma derived products)
- recombinant products
- haematopoietic progenitor cells (HPC) used for haematopoietic reconstitution:
- 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.
- Stem cell treatments and regulation - a quick guide for consumersCommonly asked questions about stem cells and regulation
- Biovigilance responsibilities of sponsors of biologicalsThis guidance is for all sponsors of products regulated as biologicals
- Guideline for the preparation of Technical Master Files for blood, blood components and haematopoietic progenitor cellsGuide for manufacturers in the development of Technical Master Files relevant to blood, blood components and haematopoietic progenitor cells.