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[S50] The Latest Cases and Further Perspective of Early Approval System in Japan
Session Chair(s)
Yoichi Sato, MPHARM
Quality and Safety Management Unit, Head, LTL Pharma 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)
Koshin Kiyohara, MPHARM, MSC
Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare (MHLW), Japan
Review of New Early Approval Systems
Junko Sugita
Japan Regulatory Lead, Regulatory Affairs, Pfizer R&D Japan, Japan
Regulatory Approval Using the Conditional Early Approval System
Goshi Murakami, MSC
Manager, Quality and Process Management section, Manufacturing technology 1, Astellas Pharma Tech Co., Ltd., Japan
Application of SAKIGAKE Designation for XOSPATA® Tablets from CMC Point of View
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