ICHPharmaceutical Regulations in Japan

The 21st ICH Public Meeting

The 21st ICH Public Meeting was held in Japan which took place at the Komaba Eminence, Meguro-ku in Tokyo on November 25, 2009.This Public Meeting aimed to provide an opportunity to give the public updated information on the progress made during the ICH Meeting in St. Louis in November 2009, and on the status of the various ICH Guidelines under development with a follow-up Q & A session.

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

Location: Komaba Eminence, 2-19-5, Ohashi Meguro-ku, Tokyo, Japan
Date: November 25, 2009

  Presentation Speakers
01_ Overview of ICH Topics Takayuki Okubo, MHLW
Topics for the Electronic Exchange of Information 02_ M2/M5/E2B(R3):Electronic Standards for the Transfer of Regulatory Information Yasuhiro Araki, MHLW(PMDA)
Efficacy Topics 03_E14R:The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs Yuki Ando, MHLW(PMDA)
04_ E2F: Development Safety Update Report Noriko Akagi, JPMA
Safety Topics 05_ S6(R1):Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals Yoko Hirabayashi, MHLW(NIHS)
06_S9:Nonclinical Evaluation for Anticancer Pharmaceuticals Shuichi Kai, JPMA
Quality Topics 08_ Q4B(Annex):Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Nobukazu Igoshi, JPMA
09_Q-IWG:Quality Implementation Working Group Yoshihiro Matsuda, MHLW(PMDA)

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