ICHPharmaceutical Regulations in Japan

The 27th ICH Public Meeting

The 27th ICH public meeting was held in Japan which took place at the Yakult Hall, Minato-ku in Tokyo, on December 14, 2012.
This public meeting aimed to provide an opportunity to update the public on the information of the progress made during the ICH meeting in San Diego in November 10-15, 2012 and on the status of the various ICH guidelines under development.
The public meeting was jointly organized by the Japan Pharmaceutical Manufacturers Association (JPMA) and the Pharmaceutical and Medical Device Regulatory Science Society of Japan (PMRJ, non-profit organization), and supported by the Federation of Pharmaceutical Manufacturers’ Associations of Japan, the Pharmaceutical Manufacturers’ Association of Tokyo, the Osaka Pharmaceutical Manufacturers Association and the Japan Pharmaceutical Association.
All the presentation used at the symposium is available in Japanese as below.
Working Language: Japanese
Simultaneous English-Japanese Translation: Not Available
None of this publication may be reproduced by any means without the prior permission of the copyright owner.
Location: Yakult Hall, 1-1-19, Higashishinbashi Minato-ku, Tokyo, Japan
Date: December 14, 2012 10:00 a.m.-4:00 p.m.

Program: 27th ICH Public Meeting (PDF 53KB)

  Presentation materials Speakers
00_Welcoming Address (PDF 282KB) Hironobu Saito, JPMA
01_Recent Developments of ICH (PDF 201KB) Yasuko Inokuma, MHLW
Topics for the Electronic Exchange of Information 02_E2B (R3): Revision of the Electronic Submission in Individual Case Safety Reports(PDF 549KB) Ayumi Endo, MHLW(PMDA)
03_ M5: Data Elements and Standards for Drug Dictionaries(PDF 917 KB) Toru Kimura, JPMA
Efficacy Topics 04_E2C(R2):PBRER Step4 Guideline (E2C(R2): Periodic Benefit-Risk Evaluation Report (PBRER)(PDF 617KB) Yoko Hattori, JPMA
Safety Topics 05_S1: Rodent Carcinogenicity Studies for Human Pharmaceuticals(PDF 2,292KB) Akiyoshi Nishikawa, MHLW(NIHS)
06_ S10: Photosafety Evaluation(PDF 546KB) Kazuhiro Hosoi, JPMA
07_ M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk(PDF 698KB) Masamitsu Honma, MHLW(NIHS)
Quality Topics 08_Q3D: Metal Impurity(PDF 397KB) Chikako Yomota, MHLW(NIHS)
09_Q7:Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients(PDF 1382KB) Tetsuhito Takarada, JPMA

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