I was curious what the success rate of NDAs filed with the EMA were. Pretty high.
"Overall, 84%
of the applications in the cohort were approved on their first
submission (“initially approved”) by both the EMA and the FDA, with the
EMA having a higher rate of “first review cycle” approval (92%) compared
with the FDA (85%)."
I'm not sure this link will work but just search EMA NDA success rate.
https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&cad=rja&uact=8&ved=2ahUKEwjIkIr539OCAxXzKUQIHXugBNMQFnoECBAQAw&url=https://www.vbb.com/media/Insights_Newsletters/Kashoki_et_al_2019_Clinical_Pharmacology___Therapeutics.pdf&usg=AOvVaw2XTK9REP9mv_JlO1VlYgcE&opi=89978449
