ICHPharmaceutical Regulations in Japan

The 28th ICH Public Meeting

The 28th ICH Public Meeting was held in Japan which took place at the Tsuda Hall, Shibuya-ku in Tokyo, on July 26, 2013.This Public Meeting aimed to provide an opportunity to give the public updated information on the progress made during the ICH Meeting in Brussels from June 1-6, 2013, and on the status of the various ICH Guidelines under development with a follow-up Q & A session.

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, Osaka Pharmaceutical Manufacturers Association and Japan Pharmaceutical Association.

All the presentation used in the meeting 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: Tsuda Hall, 1-18-24, Sendagaya Shibuya-ku, Tokyo, Japan
Date: July 26, 2013 10:00 a.m. -4:00 p.m.

Program: 28th ICH Public Meeting (PDF 36KB)

  Presentation materials Speakers
01_ Future of ICH (PDF 193KB) Hironobu Saito, JPMA
02_ Overview of ICH Topics-General Update on ICH (PDF 262KB) Kurajiro Kishi, JPMA
Topics for the Electronic Exchange of Information 03_ E2B (R3): Electronic Submission in Individual Case Safety Reports (ICSRs)(PDF 567KB) Ayumi Endo, MHLW(PMDA)
04_ M8: The Electronic Common Technical Document: eCTD (PDF 662 KB) Akiyo Fujikawa, JPMA
Safety Topics 05_ S1: Rodent Carcinogenicity Studies for Human Pharmaceuticals(PDF 540KB) Shigeru Hisada, JPMA
06_ S10: Photosafety Evaluation(PDF 1,313KB) Dai Nakae, MHLW(TMIPH)
Quality Topics 07_ Q3D: Guideline for Elemental Impurities(PDF 1,119KB) Masayuki Mishima, JPMA
08_ Q7:Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (PDF 710KB) Tetsuhito Takarada, JPMA

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