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16th DIA Japan Annual Meeting 2019

Delivering Rational Medicine for All People in the Globe


[S33] Practice of Post-Introduction of New Consultation System of Labeling for Revision

Session Chair(s)

Tetsuro  Hagiya

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)

Yoichi  Kohno

Background and Overview of New Consultation System for Package Insert Revision, and Results after Introduction

Yoichi Kohno

  • Chief Reviewer, Office of New Drug V
  • Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Yoshiaki  Toyomori

A Case That the Labeling Was Not Revised as a Result of Consultation for Package Insert Revision

Yoshiaki Toyomori

  • Associate, Regulatory Affairs Pharmaceuticals
  • Novartis Pharma K.K., Japan
Kazuaki  Sakakura

A Case That the Labeling Revision Succeeded by the New Consultation System

Kazuaki Sakakura

  • Taiho Pharmaceutical Co., Ltd., Japan