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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

  • VP, Head of Clinical Research Department
  • Shionogi & 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

Review of New Early Approval Systems

Koshin Kiyohara, MPharm, MSc

  • Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau
  • Ministry of Health, Labour and Welfare (MHLW), Japan
Junko  Sugita

Regulatory Approval Using the Conditional Early Approval System

Junko Sugita

  • Japan Regulatory Lead, Regulatory Affairs
  • Pfizer R&D Japan, Japan
Goshi  Murakami, MSc

Application of SAKIGAKE Designation for XOSPATA® Tablets from CMC Point of View

Goshi Murakami, MSc

  • Manager, Quality and Process Management section, Manufacturing technology 1
  • Astellas Pharma Tech Co., Ltd., Japan