Extension to funding available to eye and tissue sector for the direct regulatory costs associated with the biologicals regulatory framework

EXTENSION TO FUNDING AVAILABLE TO EYE AND TISSUE SECTOR FOR THE 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. The Biologicals Regulatory Framework was implemented in May 2011.

Current funding arrangements 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. Direct regulatory costs include TGA dossier application fees, evaluation fees, annual charges, annual licensing fees, audit fees and clinical trial fees. The current funding arrangements are in place up until to 30 June 2015.

In late 2014 AHMAC agreed to the conduct of an independent economic analysis of the eye and tissue sector. This work will be undertaken during 2015 with a report containing recommendations to be available for consideration by Health Ministers in early 2016. Consequently, current funding arrangements have been extended to 31 March 2016 to allow for completion of the review.

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.

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

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