Biologicals regulatory framework changes from 1 July 2018

Including changes to regulation of autologous human cell and tissue products and classification of biologicals

2 July 2018

Book pagination

Autologous human cell and tissue products

Human cell and tissue (HCT) products are those that comprise, contain or are derived from human cells and tissues.

Autologous human cell and tissue (HCT) products are those that are removed from, and applied to, the same person, i.e. the donor and the recipient are the same. These include some products commonly referred to as 'stem cell treatments'.

The definition of autologous HCT covers products defined as biologicals, and regulated under the biologicals framework, and also blood and blood components. Where an autologous HCT meets the definition of a blood component it is likely to be regulated as a medicine. Further information on the regulation of blood components is provided on the TGA website. Where the blood component is subject to significant processing (more than minimal manipulation), the definition of a blood component would not apply and it would be regulated as a biological.

Examples of autologous human cell and tissue products

Examples of autologous HCT products that this guidance applies to include:

  • blood and blood components (red cells, plasma, serum, platelets, and platelet-rich plasma (PrP))
  • skin grafts for treatment of burns
  • bone grafts
  • bone marrow transplants
  • conditioned serum
  • genetically-altered lymphocytes to target cancers
  • bone marrow-derived stem cells for non-haematological indications
  • adipose-derived cell extracts (including stromal vascular fraction (SVF))

Most of these HCT products would be regulated as biologicals under the biological regulatory framework, except blood components.

Where an autologous HCT product meets the definition of a blood component it may be regulated under the medicines framework as a blood and blood component rather than under the biologicals framework. Further information on the regulation of blood components is provided on the TGA website.

Where a blood component is subject to significant processing (more than minimal manipulation), the definition of a blood component does not apply and such a product would be regulated as a biological.

Non-TGA regulation applying to autologous human cell and tissue products

This guidance only outlines TGA regulatory requirements for these products. Regulation of autologous HCT products in Australia also involves several other regulatory bodies. Providers of autologous HCT products should be aware of all applicable regulation, such as the requirements of:

  • the Australian Health Practitioner Regulation Agency (AHPRA)
  • state, territory and national medical and dental boards or councils
  • the Australian Competition and Consumer Commission (ACCC)
  • states and territory management and administration of public hospitals
  • state and territory licensing of private hospitals.

Book pagination