ICHPharmaceutical Regulations in Japan

Workshop on the ICH M7, Q3D Guidelines (Zendentsu Hall, Tokyo)

The workshop on the ICH M7, Q3D Guidelines was held in Japan, which took place at the Zendentsu Hall, Chiyoda-ku in Tokyo on April 7, 2015.
This workshop was the opportunity to provide the detailed explanation of ICH Q3D: Guideline for elemental impurities and ICH M7: Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk.
Approximately over 350 participants from not only pharmaceutical industries but also relevant industries attended this workshop and had vigorous Q&A discussion.
This workshop on the M7, Q3D guidelines 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 at the workshop is available in Japanese as below.

Working Language: Japanese
None of this publication may be reproduced by any means without the prior permission of the copyright owner.

Location: Zendentsu Hall, 3-6, Kanda Surugadai, Chiyoda-ku, Tokyo, Japan
Date: April 7, 2015   10:00 am ~4:40 pm

  Presentation materials Speakers
10:00-10:05 Opening remarks Hironobu Saito,
ICH Q3D Guideline for Elemental Impurities
10:05-10:15 Background to Reaching the Step4 (PDF 416KB) Masayuki Mishima, JPMA
10:15-10:35 Point of View on Permitted Daily Exposure (PDF 654KB) Akihiko Hirose, NIHS
10:35-10:55 Implementation Points to Consider (PDF 626KB) Yuko Uenishi, JPMA
10:55-11:15 Point of View on the Scope (PDF 157KB) Toshinori Higashi, PMDA
11:15-11:30 Relationship between Q3D and Pharmacopoeia (PDF 664KB) Chikako Yomota, NIHS
11:30-12:30 Panel Discussion ICH Q3D EWG Member
ICH M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk
13:30-13:45 Safety (PDF 2971KB) Masamitsu Honma, NIHS
13:45-14:00 Quality  (PDF 314KB) Yukio Aso, NIHS
14:00-14:30 Point to consider of the document of clinical trial notification
(PDF 206KB)
Junichi Fukuchi, PMDA
14:30-15:00 Q&As on the Implementation of ICH M7 Guideline (PDF 196KB) Tsuneo Hashizume, JPMA
15:20-16:35 Panel Discussion ICH M7 EWG Member
16:35-16:40 Closing Remarks Kurajiro Kishi, JPMA

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