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[S50] The Latest Cases and Further Perspective of Early Approval System in Japan
Session Chair(s)
Yoichi Sato, MPharm
Associate Principal
JCR Pharmaceuticals Co., Ltd, Japan
Several years have passed since the implementation of a newly system such as SAKIGAKE and conditional early approval system, and approval cases are steadily increasing. Companies give presentations on examples of projects that have achieved early approval using such system, good points, and points that were difficult to use, by giving specific examples. In addition, PMDA also give presentation on the good points and the points that PMDA want companies to improve. In the panel discussion, based on the presentations from each presenter, we will discuss ideas for more efficient use of these systems in the future, and have positive discussions to deliver Rational medicine promptly.
Speaker(s)
Review of New Early Approval Systems
Koshin Kiyohara, MPharm, MSc
Ministry of Health, Labour and Welfare (MHLW), Japan
Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau
Regulatory Approval Using the Conditional Early Approval System
Junko Sugita
Pfizer R&D Japan, Japan
Japan Regulatory Lead, Regulatory Affairs
Application of SAKIGAKE Designation for XOSPATA® Tablets from CMC Point of View
Goshi Murakami, MSc
Astellas Pharma Tech Co., Ltd., Japan
Manager, Quality and Process Management section, Manufacturing technology 1