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Australian Cellular Therapy Regulations

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Cell Therapy

Abstract

The Therapeutic Goods Administration (TGA) is a division within the Australian Government Department of Health. The TGA is the Australian Government’s regulatory authority responsible for the regulation of therapeutic goods including medicines, medical devices, and biologicals within Australia. Governed by the Australian Therapeutic Goods Act 1989 and the Australian Therapeutic Goods Regulations 1990, therapeutic goods imported, exported, manufactured and/or supplied within Australia are required to be listed on the Australian Register for Therapeutic Goods (ARTG), to enable a continual consistent supply of goods within Australia that are safe and effective for consumer use.

In order to accommodate the continually evolving network of biotherapies, changes to legislative instruments have occurred in recent times, with a specific focus on a risk-based approach. The Australian regulation of cellular therapies is dependant to the perceived risk of product ascending from Class 1 (low risk) to Class 4 (high risk), the type of biological or blood component and its exclusions. This chapter will outline the regulatory process of cell therapy manufacture within Australia.

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Authors and Affiliations

  1. Queensland Tissue Bank, Organ and Tissue Donation Service, Metro South Hospital and Health Service, Coopers Plains, QLD, Australia

    Rosemarie Bell

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  1. Rosemarie Bell
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Correspondence to Rosemarie Bell .

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Editors and Affiliations

  1. Texas Children’s Cancer Center, Center for Cell and Gene Therapy, Houston, TX, USA

    Adrian P. Gee

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Bell, R. (2022). Australian Cellular Therapy Regulations. In: Gee, A.P. (eds) Cell Therapy. Springer, Cham. https://doi.org/10.1007/978-3-030-75537-9_3

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