I was curious what the success rate of NDAs filed with the EMA were. Pretty high.
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