Funding available to eye and tissue sector for the Biologicals Regulatory Framework - Extended transition period

In 2002 the Australian Health Ministers' Conference (AHMC) recommended that the Therapeutic Goods Administration (TGA) introduce a national regulatory framework for human tissues and emerging biological therapies (the Biologicals Regulatory Framework). In 2006, the Australian Health Ministers' Advisory Council (AHMAC) and AHMC noted that the Australian Government would meet the direct costs of regulation for Australian publicly funded facilities and not-for-profit hospital supply units for a three year transition period.   

The Biologicals Regulatory Framework was implemented in May 2011 with funding available for the three year transition period to provide support to the Australian eye and tissue sector to 31 May 2014.

A review of the regulatory costs offset has been undertaken by the TGA and the Organ and Tissue Authority (OTA) to assess the capacity to extend the cost offset beyond the three year transition period for implementation of the Biologicals Regulatory Framework.

As a result, funding arrangements to meet the direct regulatory costs associated with implementation of the TGA's Biologicals Regulatory Framework have been extended to 30 June 2015. It is expected that post 30 June 2015 the sector will meet the direct costs of regulation associated with the Biologicals Regulatory Framework.

Matters concerning eye and tissue donation continue to be an important component of the Australian Government's aim to achieve a sustained increase in organ and tissue donation rates.

If you require further information on the extended regulatory costs offset period please contact the OTA at or the TGA on

Released 20 November 2013


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