Regulator guidance

Understanding regulation of autologous human cell and tissue (HCT) products

Therapeutic Goods Administration. Guideline, Australia-wide.

Version: Last updated 24 September 2024
Last read: 24 September 2026

The regulator's guidance on its three levels of regulation for products made from a patient's own cells or tissues, which it lists as including blood components, platelet-rich plasma, platelet-rich fibrin and adipose-derived cell extracts.

What changed

1 July 2018First published 1 July 2018The page states a publication date of 1 July 2018 and a last updated date of 24 September 2024.

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