ICHPharmaceutical Regulations in Japan

ICH Japan Symposium 2012
(The 26th ICH Public Meeting)

The meeting entitled "ICH Japan Symposium 2012", the fourth ICH-branded regional meeting held in Japan which took place at the Tsuda Hall, Shibuya-ku in Tokyo on July 25, 2012.

The Symposium aimed to provide an opportunity to update the public on the progress made during the ICH meeting in Fukuoka in June 2-7, 2012 and on the status of the various ICH Guidelines under development. It was also an opportunity for participants and the ICH experts/rapporteurs to have a face to face Q&As session on all topics discussed at the Fukuoka Meetings. Approximately 300 participants from pharmaceutical industries attended the Symposium and had vigorous Q&A discussion especially in the safety and efficacy session.

The Symposium was jointly organised by the Japan Pharmaceutical Manufacturers Association (JPMA) and the Pharmaceutical and Medical Device Regulatory Science Society of Japan (PMRJ, non-profit organisation), and supported by the Ministry of Health, Labour and Welfare (MHLW), the Federation of Pharmaceutical Manufacturers' Associations of Japan, the Pharmaceutical Manufacturers' Association of Tokyo, the Osaka Pharmaceutical Manufacturers Association and the Japan Pharmaceutical Association. All the presentation used at the symposium 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 25, 2012 10:00 a.m. -4:40 p.m.

Program:ICH Japan Symposium 2012(PDF 67KB)

  Presentation materials Speakers
00_Welcoming Address(PDF 74KB) Kohei Wada, JPMA
01_Recent Developments of ICH(PDF 316KB) Naoyuki Yasuda, MHLW
02_Overviews of ICH Topics(PDF 303KB) Kurajiro Kishi, JPMA
Topics for the Electronic Exchange of Information 03_M2: Electronic Standards for the Transfer of Regulatory Information(PDF 1,667KB) Koji Shomoto, JPMA
04_E2B (R3): Revision of the Electronic Submission in Individual Case Safety Reports(PDF 389 KB) Ayumi Endo, MHLW(PMDA)
05_M5: Data Elements and Standards for Drug Dictionaries(PDF 968KB) Maiko Suzuki,MHLW(PMDA)
06_M8: Electronic Common Technical Document(PDF 539KB) Akiyo Fujikawa, JPMA
Efficacy Topics 07_E2C (R2): Clinical Safety Data Management; Periodic Benefit Risk Evaluation Report (PBRER)(PDF 646KB) Hazuki Takaura, MHLW(PMDA)
08_E3 IWG: Structure and Content of Clinical Study Report: Q&A(PDF 579KB) Kayo Shinohara, MHLW(PMDA)
09_ E14 IWG: Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs: Q&A(PDF 180KB) Maki Ito, JPMA
Safety Topics 10_ S1: Rodent Carcinogenicity Studies for Human Pharmaceuticals(PDF 197KB) Shigeru Hisada, JPMA
11_S10: Photosafety Evaluation(PDF 273KB) Dai Nakae, MHLW(TMIPH)
12_ M3 (R2) IWG: Revision of Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals: Q&A(PDF 1,130KB) Fumio Sagami, JPMA
13_ M7: Genotoxic Impurities(PDF 562KB) Shigeki Sawada, JPMA
Quality Topics 14_Q3D: Guideline for Metal Impurity(PDF 238KB) Masayuki Mishima, JPMA
15_Q11: Development and Manufacture of Drug Substances(PDF 1,145KB) Kazunori Takagi, MHLW(PMDA)
16_Q.B.S:Quality Brainstorming(PDF 153KB) Yoshihiro Matsuda, MHLW(PMDA)

Page Top

  • Office of Pharmaceutical Industry Research(OPIR)
  • Global Health
  • Stop AMR
  • APAC