ICHPharmaceutical Regulations in Japan

ICH Japan Symposium 2013
(The 29th ICH Public Meeting)

ICH Japan Symposium (The 29th ICH public meeting), the fifth ICH-branded regional meeting was held in Japan which took place at the Tsuda Hall, Shibuya-ku in Tokyo in December 10, 2013.

This symposium aimed to provide an opportunity to update the public on the information of the progress made during the ICH meeting in Osaka in November 9-14, 2013 and on the status of the various ICH Guidelines under development with Q & A session.

The symposium 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 Ministry of Health, Labour and Welfare (MHLW), 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 materials used in the meeting is available in Japanese as below.
Working Language: Japanese
Simultaneous English-Japanese Translation: Not Available

Location: Tsuda Hall, 1-18-24, Sendagaya Shibuya-ku, Tokyo, Japan
Date: December 10, 2013 10:00 a.m. - 4:40 p.m.

Program: ICH Japan Symposium 2013 (PDF 133KB)

  Presentation materials Speakers
01_Welcoming Address Hironobu Saito, JPMA
02_Recent Developments of ICH(PDF 186KB) Naoyuki Yasuda, MHLW
03_Overviews of ICH Topics(PDF 265KB) Kurajiro Kishi, JPMA
Topics for the Electronic Exchange of Information 04_M2: Electronic Standards for the Transfer of Regulatory Information(PDF 1,064KB) Koji Shomoto, JPMA
05_E2B (R3) IWG:Revision of the Electronic Submission of Individual Case Safety Reports(PDF 172 KB) Manabu Inoue, JPMA
06_M8 EWG/IWG: Electronic Common Technical Document: eCTD(PDF 590KB) Taku Watanabe, MHLW(PMDA)
Efficacy Topics 07_E2C(R2) IWG:Periodic Benefit-Risk Evaluation Report (PBRER)(PDF 233KB) Yukiko Watabe, JPMA
08_E14 IWG:The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs(PDF 717KB) Yuki Ando, MHLW(PMDA)
Quality Topics 09_ Q3D:Guideline for Elemental Impurities(PDF 622KB) Chikako Yomota, MHLW(PMDA)
10_Q7 IWG: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients(PDF 571KB) Masatoshi Morisue, MHLW(PMDA)
Safety Topics 11_S1:Rodent Carcinogenicity Studies for Human Pharmaceuticals(PDF 530KB) Mizuho Nonaka, MHLW(PMDA)
12_S10:Photosafety Evaluation(PDF 664KB) Dai Nakae, MHLW(TMIPH)
13_M7:Assessment and Control of DNA Reactive (mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk(PDF 212KB) Tsuneo Hashizume, JPMA
14_Safety Brainstorming Session(PDF 256KB) Kazuichi Nakamura, JPMA

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