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Tokyo Big Sight

Nov 10, 2019 9:30 AM - Nov 12, 2019 5:40 PM

3-11-1 Ariake, Koto-ku, Tokyo, 135-0063 Japan

16th DIA Japan Annual Meeting 2019

Delivering Rational Medicine for All People in the Globe

[S50] The Latest Cases and Further Perspective of Early Approval System in Japan

Session Chair(s)

Yoichi  Sato, MPharm

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.


Koshin  Kiyohara, MPharm, MSc

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

Junko  Sugita

Regulatory Approval Using the Conditional Early Approval System

Junko Sugita

Pfizer R&D Japan, Japan

Japan Regulatory Lead, Regulatory Affairs

Goshi  Murakami, MSc

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

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