Expediting Drug Development in Japan: A PMDA Perspective

Abstract

Review time for a new drug in Japan has shortened dramatically since the establishment of the Pharmaceuticals and Medical Devices Agency (PMDA). Nonetheless, Japan faces a new challenge so-called "Drug Loss", which means that new drugs approved overseas have not yet been developed in Japan or that development is delayed. In this manuscript, we describe how PMDA facilitates Japan's drug development to continuously provide innovative drugs to patients.