ICHPharmaceutical Regulations in Japan

The 19th ICH Public Meeting

The 19th ICH Public Meeting was held in Japan which took place at the Komaba Eminence, Meguro-ku in Tokyo on December 16, 2008.This Public Meeting aimed to provide an opportunity to give the public updated information on the progress made during the ICH Meeting in Brussels in November 2008, 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: December 16, 2008

  Presentation materials Speakers
01_ Overview of ICH Topics Takayuki Okubo, MHLW
Topics for the Electronic Exchange of Information 02_ M2:Electronic Standards for the Transfer of Regulatory Information, eCTD Yasuhiro Araki, MHLW(PMDA)
Efficacy Topics 03_E16:Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure and Format of Qualification Submissions Sanae Yasuda, JPMA
  04_ GTDG: Gene Therapy Discussion Group Wataru Toriumi, JPMA
Safety Topic 05_ S6(R1):Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals Kazushige Maki, MHLW(PMDA)
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 Tsuneo Okubo, JPMA
09_Q8(R1):Pharmaceutical Development Yasuhiro Okuda, MHLW(NIHS)

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