Posted by Michael Wonder on 27 Sep 2018
TGA annual performance statistics report: July 2017 to June 2018
27 September 2018 - The statistics contained within this report cover the period 1 July 2017 to 30 June 2018, and contribute to annual publications that track the TGA's progress against the priorities established for the financial year.
Fourteen priority review determinations and two provisional determinations were approved under the new priority review pathway and the new provisional approval pathway respectively. Of the 14 medicines receiving priority review determination, five were also approved for registration in 2017-18. The median timeframe for these registrations via the priority review pathway was 98 working days, against a target timeframe of 150 working days.
Eleven orphan drug designations were approved in 2017-18 under the reformed orphan drug program, with five additional designations approved under the previous orphan drug program (where the designation application was received prior to 1 July 2017). Twenty-one orphan drugs were approved in 2017-18, including one that received its designation under the reformed program.
