ICHPharmaceutical Regulations in Japan

The 25th ICH Public Meeting

The 25th ICH Public Meeting was held in Japan which took place at the Nissho Hall, Minato-ku in Tokyo on December 05, 2011.This Public Meeting aimed to provide an opportunity to give the public updated information on the progress made during the ICH Meeting in Seville in November, 2011, and on the status of the various ICH Guidelines under development with a follow-up 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.

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

Location: Nissho Hall, 2-9-16, Toranomon, Minato-ku Tokyo, Japan
Date: December 5, 2011 10:00 a.m. -4:00 p.m.

  Presentation materials Speakers
01_Welcoming Address Kohei Wada, JPMA
02_ Overview of ICH Topic Yasuko Inokuma, MHLW
Safety Topics 03_ S1A: Need for Carcinogenicity Studies of Pharmaceuticals Akiyoshi Nishikawa, MHLW(NIHS)
04_ M7: Assessment and Control of DNA Reactive(Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk Shigeki Sawada, JPMA
Topics for the Electronic Exchange of Information 05_ M5: Data Elements and Standards for Drug Dictionaries Maiko Suzuki, MHLW(PMDA)
Efficacy Topic 06_ E3: Structure and Contents of Clinical Study Reports Kayo Shinohara, MHLW(PMDA)
07_E2C(R2): Clinical Safety Data Management; Periodic Benefit-Risk Evaluation Report (PBRER) Yukiko Watabe, JPMA
Quality Topics 08_ Q3D: Guideline for Metal Impurities Chikako Yomota, JPMA
09_Q11:Development and Manufacture of Drug Substances(Chemical Entities and Biotechnological/Biological Entities) Kiyotoshi Matsumura, JPMA

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