Progress on the development of a regulatory framework for tissues and emerging biological therapies
Status as at 30 April 2004
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.
As a result of an extensive process of policy development and public consultation, the TGA proposes to include, in the approaching Trans Tasman regulatory framework, a comprehensive system for the regulation of cellular and tissue based therapies. It will be characterised by the following principles:
- All therapeutic products definable as cellular and tissue therapies, including cell-based gene therapy products, will be included in the scope of the regulatory framework and the current complex nexus of exemptions will be replaced with one exemption for medical procedures.
- The level of regulation will be classified and commensurate with the risks posed by the therapies to the individual and the community. Thus, risk assessment and risk management principles are an integral part of the new approach.
- The three tiered classification system will align regulation of therapies to standards (Class 1), to standards and GMP (Class 2) and to standards, GMP and pre-market evaluation (Class 3), 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.
- The exclusion or exemption of tissues from the need for pre-market evaluation of safety and efficacy will no longer be automatic but will be subject to review where public health considerations mandate it.
These principles were developed and supported through the consultation process in 2003. A second round of stakeholder workshops were conducted by the TGA during February to April 2004, to refine details of the framework. The remaining concerns expressed at these workshops were presented to the Expert Advisory Group on Regulation of Cellular and Tissue Based Therapies, for its guidance. The recent Symposium, NATA Accreditation and TGA's Licensing: What are their roles in manufacture of human cellular and tissue based therapies, was a direct result the EAG's recommendation to explore options with regard to licensing steps of manufacture performed at pathology laboratories.
In many respects 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 decision on whether a parallel framework for regulation of xenotransplants of viable animal cells and tissues will be required awaits the outcome of recent consultations and ethical considerations by the NH&MRC.
The TGA has initiated processes to determine the cost of regulation and impact on industry. Endorsement of the regulatory framework must be obtained by the Australian Health Ministers Advisory Council and the Australian Health Ministers Conference.
Review of the code of Good Manufacturing Practice and adoption, or in some cases development, of standards will commence shortly.