Posted by Michael Wonder on 09 Mar 2021
Rationales of delay and difference in regulatory review by Japan, the USA and Europe among new drugs first approved in Japan
6 March 2021 - The objective of the study was to clarify the rationales of delay or difference in the review of new drug applications among regulatory authorities for new drugs, those first approved in the world being in Japan.
Among 80 new drugs first approved in Japan from 2008 to 2019, we identified those subsequently approved in the USA or Europe. Significant delays in approval time and the rationales for the delays were assessed among the Pharmaceuticals and Medical Devices Agency, the US FDA and the EMA.
