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This guidance is for sponsors of autologous human cells and tissues (HCT) products. It explains
how we apply regulation based on the risk associated with the product and when some
autologous HCTs may be excluded from TGA regulation or exempt from some TGA regulations.
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. One group of autologous HCT products is those commonly referred to as 'stem cell treatments'.
Some examples of human cell and tissue products that can be autologous:
This document specifies only TGA regulatory requirements. Other regulatory requirements that
may apply to these products include:
The level of regulation for autologous HCT products is based on the level of risk to the public.
The level may vary due to the level of external governance and clinical oversight, or depending on the manufacturing processes or intended use of the autologous HCT product.
To determine how your autologous product will be regulated check if it is:
For autologous HCT products that are not excluded from TGA regulation, the product will be
one of the following:
Biologicals and excluded autologous HCTs must not be advertised to consumers.
| Regulatory pathway | Excluded from TGA regulation | Regulated by TGA with some exemptions (medicine* or biological) | Fully regulated by TGA (medicine* or biological) |
|---|---|---|---|
| Eligibility criteria |
|
|
|
*Medicine: if meets the definition of blood, blood component or haematopoietic progenitor cells (HPC).
If an autologous HCT product is not excluded or not exempt, then it is fully regulated as either a biological or blood component.
If your autologous HCT product is not a blood component, then it will be regulated as a
biological. Please refer to the Australian Regulatory Guidelines for Biologicals (ARGB).
‘Blood’ and ‘blood components’ and haematopoietic progenitor cells (HPC) are defined in the
latest Therapeutic Goods (Manufacturing Principles) determination:
If not excluded or exempt, autologous blood, blood components and haematopoietic progenitor cells (HPC) are regulated as a medicine in the same way as non-autologous blood, blood components and HPCs.
If your product does not fit the appropriate definition, then it will be regulated as a biological.
Title changed from 'Autologous human cells and tissues products regulation' to 'Understanding regulation of autologous human cell and tissue products' as part of migration to new 'Guidance' content type:
Updates to reflect regulatory changes to conditioned serum.
Original publication incorporating new legislative changes and information previously published on the TGA website.
Title changed from 'Autologous human cells and tissues products regulation' to 'Understanding regulation of autologous human cell and tissue products' as part of migration to new 'Guidance' content type:
Updates to reflect regulatory changes to conditioned serum.
Original publication incorporating new legislative changes and information previously published on the TGA website.
The Department of Health, Disability and Ageing acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.
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