Challenges and recent efforts in PMDA to promote an appropriate development of new drug

Abstract

Pharmaceuticals and Medical Devices Agency (PMDA) has been working to promote a proper drug development by academia and venture capital through consultation on R&D strategy. To promote an international harmonization in global drug development, PMDA proposed to establish a new international guideline focusing on multi–regional clinical trials and E17 guideline is currently under discussion in ICH. Recently, electronic data have been actively been utilized in review and safety assessment. Further challenges will continue for conducting appropriate review and safety measure of drugs as well as for promoting drug development.