Regulation of cellular therapies: the Australian perspective.

The first step in the process of regulating cell-based products in Australia was taken in 1991, when the code of good manufacturing practice (cGMP) for 'Blood and Blood Components' was instituted. Paradoxically, it focused on the regulation of plasma fractionation, the non-cellular component of blood. Subsequently, Australia's regulatory body for medicinals, the Therapeutic Goods Administration (TGA), has clearly stated that all cell-based therapies utilizing components of blood and/or tissues will be regulated. The final landscape for the regulation of cellular therapies has yet to be defined, but is likely to be clarified within the next 12 months. The current cGMP for 'Blood and Tissues' is the regulatory document for all aspects of cell processing, including standard blood components (cellular and plasma), cord blood and allogeneic cells for storage. Currently, there are some exemptions to government regulation, and the most important of these is autologous hemopoietic stem cells (HSC). Indeed, no licensing is required for processing of HSC at the moment, although most centers subject themselves to a self-imposed auditing system through the National Association of Testing Authorities, Australia. However, it is anticipated that within 12 months this and the other exemptions within the Act will be removed. The TGA will become the formal regulator of all cell-based therapies, and laboratories will be required to apply for cGMP auditing and licensing. It is likely that the Foundation for the Accreditation of Cellular Therapy (FACT) guidelines or others of a similar nature, will form the basis of one of the regulatory standards for HSC processing. Of particular note is the inclusion of apheresis as an integral component of cGMP licensing.