Posted by Michael Wonder on 13 Feb 2018
All TGA approvals for prescription medicines in 2017 met the statutory timeframe of 255 working days
9 February 2018 - A recent media report suggesting that half of TGA approvals for prescription medicines in 2017 exceeded statutory timeframes is incorrect.
The law provides that TGA has 255 working days to complete an evaluation. This does not include days spent waiting for the sponsor to respond to TGA's questions.
The average approval time for new chemical entities in 2016-17 was 220 working days and the range was 161-238 days. All of the evaluations were completed within the statutory timeframe of 255 days.
