ICHPharmaceutical Regulations in Japan

ICH Japan Symposium 2010
(The 23rd ICH Public Meeting)

ICH Japan Symposium 2010, the third ICH-branded regional meeting was held in Japan which took place at the Tsuda Hall, Shibuya-ku in Tokyo, on December 2, 2010.This Public Meeting aimed to provide an opportunity to give the public updated information on the progress made during the ICH Meeting in Fukuoka from June 6-11, 2010, and on the status of the various ICH Guidelines under development with a special session regarding pharmacovigilance. In this session, we had a comprehensive discussion about the gap among E2 guidelines (E2A, E2B, E2D, E2E, E2F) including E2C, depending on the regions.

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 Ministry of Health, Labour and Welfare (MHLW), 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 as below (Most of the presentation materials are in Japanese).

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, Sendagi Shibuya-ku, Tokyo, Japan
Date: December 2, 2010 10:00 a.m.-4:40 p.m.

Program ICH Japan Symposium 2010 (PDF 69KB)

  Presentation materials Speakers
00_Welcoming Address(PDF 42KB) Kohei Wada, JPMA
Session 1:ICH Topics 01_20 years of ICH (and beyond)(PDF 533KB) Michiko Suzuki, MHLW
02_Overvew of ICH Topics(PDF 255KB) Kurajiro Kishi, JPMA
Topics for the Electronic Exchange of Information 03_M2:Electronic Standards for the Transfer of Regulatory Information(PDF 250KB) Takeshi Adachi, JPMA
04_E2B(R3):Data Elements for Transmission of Individual Case Safety Reports(PDF 364KB) Ayumi Endo, MHLW(PMDA)
05_M5:Data Elements and Standards for Drug Dictionaries(PDF 472KB) Izumi Oba, MHLW(PMDA)
06_M8(eCTD):Electronic Common Technical Document(PDF 283KB) Koji Shomoto, JPMA
Efficacy Topics 07_E2C(R2):Periodic Benefit-Risk Evaluation Report(PDF 178KB) Okudaira Tomoko, MHLW(PMDA)
08_E14 IWG:Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs:(PDF 154KB) Maki Ito, JPMA
Safety Topics 09_S6(R1):Preclinical Safety Evaluation of Biotechnology Derived Pharmaceuticals(PDF 297KB) Kazuto Watanabe, JPMA
10_S10:Photosafety Evaluation(PDF 333KB) Dai Nakae, MHLW(TMIPH)
11_M3(R2) IWG:Revision of Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals(PDF 169KB) Fumio Sagami, JPMA
12_M6, GTDG:Virus and Gene Therapy Vector Shedding and Transmission(PDF 606KB) Wataru Toriumi, JPMA
13_M7:Genotoxic Impurities(PDF 869KB) Masamitsu Honma, MHLW(PMDA)
Quality Topics 14_Q3D:Guideline for Metal Impurity(PDF 109KB) Masayuki Mishima, JPMA
15_Q4B:Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions(PDF 244KB) Masaaki Wada, JPMA
16_Q11:Development and Manufacturing of Drug Substances(PDF 165KB) Kazunori Takagi, MHLW(PMDA)
17_Q-IWG:Quality Implementation Working Group(PDF 139KB) Yoshihiro Matsuda, MHLW(PMDA)
Special Session: Pharmacovigilance 18_PV panel 1: Summary(PDF 376KB) Daisaku Sato, MHLW
19_PV panel 2: Industry(PDF 173KB) Yoko Hattori, JPMA
20_PV panel 3: Regulatory(PDF 133KB) Tomoko Okudaira, MHLW(PMDA)

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