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[S33] Practice of Post-Introduction of New Consultation System of Labeling for Revision
Session Chair(s)
Tetsuro Hagiya
Head, Labeling Group, Product Maintenance & Market Support Regulatory
Sanofi K.K., Japan
Revisions of labeling for eight pharmaceutical ingredients were implemented based on the new consultation system from the start of the new system to May 2019. On the other hand, although consultations were considered, some proposals for revision of labeling have not been accepted in pre-consultations. Based on the original principle and positioning of the original consultation, we will discuss optimal approaches for utilizing the system and what kind of challenges exist in the government and companies, hope to further promote the utilization of the system in the future.
Speaker(s)
Background and Overview of New Consultation System for Package Insert Revision, and Results after Introduction
Yoichi Kohno
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Chief Reviewer, Office of New Drug V
A Case That the Labeling Was Not Revised as a Result of Consultation for Package Insert Revision
Yoshiaki Toyomori
Novartis Pharma K.K., Japan
GPRM Japan, Regulatory Affairs Japan
A Case That the Labeling Revision Succeeded by the New Consultation System
Kazuaki Sakakura
Taiho Pharmaceutical Co., Ltd., Japan