Posted by Michael Wonder on 03 Apr 2018
Half yearly performance snapshot: July to December 2017
3 April 2018 - The TGA has maintained a high level of activity while also progressing regulatory reforms over the reporting period, 1 July to 31 December 2017.
Over the reporting period, 166 Category 1 (including 22 New Chemical Entities (NCE) and 55 new generic medicines) and 695 Category 3 applications were approved. This represents an increase against the equivalent period in 2016 (156 Category 1 and 665 Category 3 applications). Mean and median approval times were below the statutory timeframes.
Mean and median approval times for new generic medicines (190 and 185 working days respectively) and Product Information changes (130 and 129 working days respectively) were below that of NCE (209 and 212 working days respectively) as these application types are typically processed without referral to independent expert advisory committees.
