You might want to read Mayo's link carefully. It is so weird that posters constantly attack the FDA but hold the TGA on a pedestal. Mayo's link, and several I have posted over the years including the 2018 version of his link, clearly report hard data, not opinions, about the FDA being faster than other agencies and usually the first to approve. This is very pertinent for Missling and Anavex when deciding which NDA/MAA to file first
The FDA is not out to get Missling or Anavex - at least not any more than the TGA.
Lets look at a few stats/quotes from that link:
On page 1 in the easy to read chart - the FDA averages 243 days and the TGA averages 346 days to approve a drug after application. ---- so the terrible FDA averages 8 months to approve and the TGA more than 3 months longer.
On page 19 for the FDA. 85% of new drugs approved first or concurrently by the FDA compared to the rest of the world!
"85% OF THE NASs APPROVED IN 2019 BY FDA WERE APPROVED BY FDA FIRST OR WITHIN ONE MONTH OF THEIR FIRST APPROVAL BY EMA, PMDA,
HEALTH CANADA , SWISSMEDIC OR TGA "
AND
"15% OF THE NASs APPROVED IN 2019 BY FDA WERE APPROVED BY EMA, PMDA, HEALTHCANADA, SWISSMEDIC OR TGA FIRST OR MORE THAN ONE MONTH BEFORE BEING APPROVED BY FDA"
Meanwhile, on page 23 for the TGA --- they approved first of concurrently only 1/6 times!!
"16% OF THE NASs APPROVED IN 2019 BY TGA WERE APPROVED BY
TGA FIRST OR WITHIN ONE MONTH OF THEIR FIRST APPROVAL BY FDA, EMA, PMDA, HEALTH CANADA OR SWISSMEDIC"
AND
"84% OF THE NASs APPROVED IN 2019 BY TGA WERE APPROVED BY FDA, EMA, PMDA,HEALTH CANADA OR SWISSMEDIC FIRST OR MORE THAN ONE MONTH BEFORE BEING APPROVED BY TGA"
And it gets worse "THE MEDIAN SUBMISSION GAP TO TGA FOR THESE NASs WAS 535 DAYS" The TGA doesn't even typically get the NDA until 1 1/2 years after the FDA or other agency gets the application. As I mentioned in a couple posts from 2019 the FDA (and to a near extent the EMA) leads and the TGA follows. They take 3 months longer to approve medications that are already approved by the FDA (and often EMA)
The FDA also has the most drug approvals (Figure 1 slide 3) 47 vs 25 for the TGA.
A few years back, I looked at the then 16 MS medications and 11 were approved first by the FDA, 4 by the EMA and 1 by the TGA.
