Significant changes in Japanese pharmaceutical regulations and procedures are impacting the development of new drugs in Japan as well as global development programs. This tutorial will describe the major drivers of the regulatory system, including the Pharmaceuticals and Medical Devices Agency (PMDA) and Ministry of Health, Labor and Welfare (MHLW), regulatory procedures during drug development (Consultations with PMDA and Clinical Trial Notifications), the integration of Japan drug development with East Asian and global drug development, orphan drug regulation, accelerated development and approval opportunities for regenerative and other innovative therapies, and J-NDA preparation and review. Several development strategies available to address Japanese requirements for new drug approval, as well as selected post-approval requirements, will be discussed.

The benefit of the tutorial is that participants will gain a practical understanding of the specific steps necessary to prepare a registration strategy for Japan, to meet with the Japanese Authorities, to submit successful clinical trial and marketing applications, and to enter the Japanese pharmaceutical market.