DIRECT REGULATORY COSTS ASSOCIATED WITH THE BIOLOGICALS REGULATORY FRAMEWORK

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 an initial transition period of three years. The Biologicals Regulatory Framework was implemented in May 2011.

Funding arrangements to offset the direct regulatory costs that would have been incurred by Australian publicly funded facilities and not-for-profit hospital supply units as a consequence of the implementation of the TGA Biologicals Regulatory Framework have been available to the eye and tissue sector since implementation and are in place up until 31 March 2016. 

TGA have advised that in order to allow sufficient time for TGA to screen applications and raise evaluation fee invoices where necessary, eye and tissue banks are encouraged to submit applications no later than 17 March 2016.

As communicated to the eye and tissue sector in February 2015, from 1 April 2016 the sector will be required to meet the direct and indirect costs of regulation associated with the TGA 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. We will continue to work with the eye and tissue sector on recommendations arising from the independent economic analysis.

If you require further information please contact the OTA at enquiries@donatelife.gov.au or the TGA on bloodandtissues@tga.gov.au.

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