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Proposed regulatory framework for tissues and emerging biological therapies

Introduction

In July 2002, the Australian Health Ministers Conference (AHMC) recommended that the TGA introduce a national regulatory framework for human tissues and emerging biological therapies and that the therapeutic goods legislation be amended to accommodate therapeutic goods manufactured from viable human and animal tissues.

To this end, consultants, Matthews Pegg Consulting (mpconsulting), were retained to seek out and consult with stakeholders on the broad scope of tissue and cell activities in Australia and to develop a regulatory framework to accommodate these technologies.

To further clarify the extent of human tissue and cellular therapies in Australia, the TGA is requesting organisations and individuals to complete and return a Facility Registration Form <http://www.tga.gov.au/bt/facilityreg.htm> to provide it with details of relevant activities undertaken and products supplied by their organisations.

A second round of consultations provided stakeholders with further opportunity for public discussion and comment on the regulatory framework, the legislative underpinning of the framework and other stages leading to implementation.

During 2005, the TGA continued consulting with stakeholder groups on specific issues requiring development to underpin the framework and its regulatory structures. Jurisdictional input to the framework and its proposed options for funding arrangements has been a significant milestone in drawing together critical elements of the proposal.

The Blood and Tissues Unit of the Office of Devices, Blood and Tissues, TGA, maintains and posts public correspondence and reports on the regulatory framework for tissues and emerging biological therapies on this site to provide a record of the framework's development for stakeholders.

Further information on the proposed regulatory framework, public correspondence and documents issued through mpconsulting and the TGA are available via the links below:

Consultation - Round 1

A number of consultation workshops were held in April and May 2003 to provide stakeholders with an opportunity to comment on issues raised in the Discussion Paper relating to the proposal for a regulatory framework for human tissues and emerging biological therapies. The discussion and comments were sought so that a preferred regulatory model for human tissue and emerging biological therapies can be developed.

Consultation - Round 1 follow-up

The following links are to copies of letters sent to stakeholders who received the first discussion paper, or who attended the consultations on the regulation of human tissues and emerging biological therapies. A summary of outcomes from the first round of consultations is also provided.

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Consultation - Round 2

The TGA undertook another round of consultations with stakeholders. Letters of invitation, the workshop schedule and "Summary of Proposed Framework for the Regulation of Cell and Tissue Therapies" were sent to stakeholders on 23 January 2004. Copies of these documents can be accessed through the links below

Facility registration

The following links are to a copy of the letter sent to stakeholders requesting their participation in the Facility Registration program and a Facility Registration Form that can be downloaded for completion. This program was initiated in response to support given to the proposal by stakeholders who attended the consultations on the regulation of human tissues and emerging biological therapies.

Although the reply date was initially set at 11 September 2003, the letter to stakeholders remains current and a Facility Registration Form may be completed and returned to the TGA at any time.

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