Posted by Michael Wonder on 28 Sep 2016
TGA performance statistics report: July 2015 to June 2016
28 September 2016 - The TGA, through the Performance Statistics Report, provides detailed statistical information on its performance to stakeholders.
This is the first time that the TGA have published the report in this format and will continue to provide this information annually for each July to June period.
Over the past three years, the number of submissions received across some Category 1 application types has been relatively stable. Applications for new generic medicines and Extension of Indications (EOI) in 2015-16 were comparable to those received in 2013-14, following a slight drop in 2014-15. While New Chemical Entity (NCE) submissions were higher in 2015-16 than in 2014-15, they remained down on the high number received in 2013-14.
All Category 1 submissions processed in 2015-16 were within the legislated 255 working day timeframe with a modest decrease in average approval times for NCE, EOI and generic medicine applications. Median approval times for all application types were lower than previous years, including Additional Trade Name applications which reduced to 35 TGA working days following the introduction of a 45 day legislated timeframe from 1 July 2015.
