Abstract

FROM DONOR TO PATIENT: A CRITICAL EXAMINATION OF THE AUSTRALIAN REGULATORY FRAMEWORKS FOR BLOOD AND BLOOD PRODUCTS

Rosfeena Joseph*, Raji M. K.

ABSTRACT

This study provides a comprehensive analysis of the regulatory framework governing blood and blood products in Australia. The scope of this research is a detailed examination of the legal and technical requirements, from donor to patient, to ensure public safety and quality. The research employs a descriptive analysis, systematically gathering and synthesizing data from primary and secondary sources, including the Therapeutic Goods Act 1989 and official documents from the Therapeutic Goods Administration (TGA) and the National Blood Authority (NBA). The main findings reveal that Australia's regulatory philosophy is a standards-based model, involving a multi-agency approach. This framework is distinguished by its emphasis on international harmonization and the rapid adoption of new technologies. A key strength of the Australian model is its inherent flexibility to adapt to global advancements while maintaining a high level of quality. The study concludes that while Australia’s multi-agency approach ensures robust oversight, there is potential for increased efficiency in its coordination. Ultimately, the future of blood regulation in Australia lies in its ability to blend strong, enforceable standards with flexibility and responsiveness to global advancements.

Keywords: Regulatory Frameworks; Australia; Blood and Blood Products.