Regulatory Oversight of Blood, Tissues and Emerging Biological Therapies in Australia and New Zealand

Abstract

The regulation of blood, blood product, tissue and gene technology therapies are viewed as critical to protecting the health of Australians. In response to the growing community concerns regarding the ethics, quality and safety of tissue and biological therapy products, the Australian Health Ministers Council, in 2002, recommended the development and introduction of a regulatory framework for tissues and emerging biological therapies. The proposal for tissues and emerging biological therapies parallels the regulation of blood and blood components introduced by the TGA in 2000 following similar ministerial recommendations, policy development and consultation A comprehensive system for the regulation of cellular and tissue based therapies within a proposed trans Tasman framework will be characterised by the following principles: • All therapeutic products definable as cellular and tissue therapies, including cell-based gene therapy products, will be overseen by the system • The level of regulation will be classified according to the risks posed by the therapies to the individual and the community. • The classification system will align regulation of therapies to: – standards – standards and GMP – standards, GMP and pre-market evaluation according to the level of risk. • All facilities responsible for the manufacture and supply of cellular and tissue based products will be required to register their organisation with the TGA.