In 2002, the Australian Health Ministers Conference 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.

The TGA recently contracted consultants to assist the TGA by working with stakeholders to develop a proposal to progress the decision of Health Ministers. In order to facilitate consultations, a Discussion Paper has been developed for broad circulation to relevant stakeholders. This Discussion Paper includes background information about relevant issues, consideration of international precedent and a range of options for progressing the proposal.

Please note there is a "Corrigenda" page, containing additional information, that is provided in a separate file.

How to access a pdf document

• Discussion paper - The regulation of human tissues and emerging biological therapies (pdf, 202kb)
• Corrigenda to the discussion paper on the regulation of human tissue and emerging biological therapies (pdf, 8kb)

A number of workshops were held in April and May 2003 to provide stakeholders with an opportunity to make comments about the issues raised in the Discussion Paper in order that a preferred regulatory model for human tissue and emerging biological therapies can be developed. See: Summary of outcomes of consultations on the regulation of human tissues and emerging biological therapies <http://www.tga.gov.au/bt/humantiss_outcomes.htm>