ICHPharmaceutical Regulations in Japan

The 30th ICH Public Meeting
(Nagai Kinen Hall, Tokyo)

The 30th ICH public meeting was held in Japan which took place at the Nagai Kinen Hall, Shibuya-ku in Tokyo in July 10, 2014.

This public meeting aimed to provide an opportunity to update the public on the information of the progress made during the ICH meeting in Minneapolis from May 31 to June 5, 2014 and on the status of the various ICH Guidelines under development with 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.
None of this publication may be reproduced by any means without the prior permission of the copyright owner

Working Language: Japanese
Simultaneous English-Japanese Translation: Not Available

Location Date
Nagai Kinen Hall,
2-12-15, Shibuya Shibuya-ku, Tokyo,
Japan
July 10, 2014 10:00 am ~ 4:20 pm

Program: The 30th ICH Public Meeting (English) (PDF 29KB)

  Presentation materials Speakers
01_ Future of ICH (PDF 1,213KB) Hironobu Saito, JPMA
02_ Recent Developments of ICH (PDF 176KB) Junko Sato, JPMA
Safety and Multidisciplinary Topics 03_M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk(PDF 268KB) Junichi Fukuchi, MHLW(PMDA)
Topics for the Electronic Exchange of Information 04_ M8: Electronic Common Technical Document: eCTD (PDF 499 KB) Taku Watanabe, MHLW(PMDA)
Future ICH Topics 05_ Overview of Future ICH Topics (PDF 333KB) Kurajiro Kishi, JPMA
06_S5 (R3) informal WG: Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility (PDF 328KB) Michio Fujiwara, JPMA
07_E6 (R2): Good Clinical Practice (GCP) (PDF 217KB) Kazuhiro Matsui, MHLW(PMDA)
08_Informal Quality Discussion Group (IQDG) (PDF 268KB) Yoshihiro Matsuda, MHLW(PMDA)
Quality Topics 09_ Q3D: Guideline for Elemental Impurities (PDF 511KB) Chikako Yomota, MHLW(PMDA)
10_ Q7:Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (PDF 494KB) Tetsuhito Takarada, JPMA

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