In accordance with the Principles and Guidelines for National Standard Setting and Regulatory Action by Ministerial Councils and Standard-setting Bodies as updated in June 2004, the TGA has prepared for public review a Regulatory Impact Statement (RIS) on the proposed framework for Human Cell, Tissues and Cellular and Tissue-based Products. The TGA invites interested parties, in particular stakeholders, to view the RIS.

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Regulatory impact statement for human cell, tissues and cellular and tissue-based products (pdf,186kb)

A RIS is a mandatory document for all reviews of existing legislation, proposed new or amended regulation and proposed treaties involving regulation which will directly affect business, have a significant indirect effect on business, or restrict competition. It is prepared by the agency responsible for a regulatory proposal following consultation with affected parties.

The RIS that has been developed in relation to the proposed regulatory framework for Human Cell, Tissues and Cellular and Tissue - based Products, reviews the options available to the TGA to address the recommendation by the Australian Health Ministers' Conference (2002) that these products should be subject to regulatory control by the TGA.

Furthermore, the RIS outlines international regulatory schemes and practice for human cell and tissues; it comments on the consultation process between the TGA and the stakeholders and notes stakeholder concerns and preferences within the context of the AHMC recommendation.

Finally, the RIS analyses the regulatory options available to the TGA and examines the probable impact on potential stakeholders.

The TGA would like to thank stakeholders for their participation in the consultations and contribution to the development of a regulatory framework.