All TGA approvals for prescription medicines in 2017 met the statutory timeframe of 255 working days

This TGA behind-the-news article was published on 9 February 2018. Behind-the-news articles are published in response to issues that are of interest to the community at a point in time, for example, subjects that have been in the media.

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.

TGA reports the number of working days taken to complete evaluations in our annual reports, see: Annual performance statistics report: July 2016 to June 2017 - 1. Prescription medicines