Module 1 2021

28/06/2021

New PMDA Structure

PMDA June 2012 Distribution to third parties is not allowed

17

Clinical Development Pathways in Japan

Global Clinical Development Without Japan

Global Phase II

Global Phase III

Phase I

NDA

Launch

Full Development

Phase II

Phase I

Phase III

NDA Launch

Bridging Concept

Phase I

Phase II NDA Launch

Global Phase II

Global Phase III

Global Clinical Development With Japan

Phase I

NDA Launch

Japan APAC Development

Phase I

Phase II

Phase III

NDA Launch

Distribution to third parties is not allowed

18

9