Regulation Policy for Cell and Tissue Therapies in Australia

Abstract

In Australia, therapeutic goods are regulated by the Australian Government through the Therapeutic Goods Administration. In recent times, there have been significant changes to legislative instruments to accommodate the emergence of biotherapies, and a new regulatory framework was implemented in 2013. Therapeutic goods are regulated as medicines, devices, or biologics. With some exemptions and exceptions, human cellular and tissue products are regulated as biologics. The new regulation has taken a risk-based approach, with the level of regulation reflecting the perceived risk of the product, and products are classified from class 1 (low risk) to class 4 (highest risk). Other than for class 1 products, manufacturers must demonstrate conformance with the Australian Code of Good Manufacturing Practice and compliance with relevant Therapeutic Goods Orders and Standards through the submission of dossiers. The higher the classification of product, the more rigorous the dossier requirements. Listing of products on the Australian Therapeutic Goods Register is required for all products with some exceptions. The new regulatory framework provides greater clarity for manufacturers and strives to harmonize with international standards.