Summary of proposed framework for the regulation of cell and tissue therapies
23 January 2004
In mid 2002 Australian Health Ministers agreed that the Therapeutic Goods Administration (TGA) introduce a national regulatory framework for human tissues and emerging biological therapies. Ministers also agreed that the therapeutic goods legislation be amended to accommodate therapeutic goods manufactured from viable human or animal tissue.
Since the decision of Health Ministers, the TGA has been working to develop a proposed regulatory system for human tissue and emerging biological therapies.
Based on the feedback received from the workshops and from written submissions, the TGA has now developed a framework for the regulation of human and animal cell and tissue therapies. The purpose of this Paper is to provide stakeholders with an outline of this framework and to detail the further development work that the TGA wishes to undertake in consultation with stakeholders prior to the implementation of the proposed new regulatory framework.
Summary of proposed framework for the regulation of cell and tissue therapies (pdf, 83kb)