ICHPharmaceutical Regulations in Japan

ICH Japan Symposium 2016
(The 35th ICH Public Meeting)

An ICH regional public meeting entitled ICH Japan Symposium 2016 (The 35th ICH public meeting) was held in Japan which took place at the Zendentsu Hall, Chiyoda-ku in Tokyo in December 14, 2016.

This public meeting aims to provide an opportunity to update the public on the information of the progress made during the ICH meeting in Osaka from November 5 to 10, 2016. At the beginning, we had presentations about the present situation of ICH then move to the topic on the status of various ICH Guidelines. Approximately over 170 participants from not only pharmaceutical industries but also relevant industries attended this meeting and had vigorous Q&A discussion.

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 Ministry of Health, Labour and Welfare (MHLW), 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

Date and Place:
Date Place
December 14, 2016
10:00 am ~3:45 pm
Zendentsu Hall,3-6, Kanda Surugadai, Chiyoda-ku,
Tokyo, Japan

Program: ICH Japan Symposium 2016 (Japanese) (PDF 309KB)

  Presentation Materials Speakers
Opening remarks Akira Kawahara,
Movement of ICH 01_Progress in one year after Renovation &
Future challenge (PDF 731KB)
Nobumasa Nakashima,
02_Osaka Meeting through the position of JPMA
– mainly strategic discussion/ New Topics
(PDF 984KB)
Masafumi Yokota,
Topics for the Electronic
Exchange of Information

Session Chair:
Manabu Inoue, JPMA
Q&As on Electronic Transmission of Individual
Case Safety Reports (ICSRs) (PDF837KB)
Ayumi Endo,
Taku Watanabe,
Safety Topics

Session Chair:
Kazuto Watanabe, JPMA
05_S5 (R3) EWG
Revision on Detection of Toxicity to
Reproduction for Medicinal Products and
Toxicity to Male Fertility (PDF244KB)
Michio Fujiwara,
06_S11 EWG
Nonclinical Safety Testing in support of
Development of Pediatric Medicines (PDF321KB)
Yuji Takahashi,
07_M10 EWG
Bioanalytical Method Validation (PDF952KB)
Akiko Ishii,
Efficacy Topics

Session Chair:
Seiki Kanazawa, JPMA
08_ E9 (R1) EWG
Addendum to Statistical Principles for Clinical
Trials on Choosing Appropriate Estimands
and Defining Sensitivity Analyses
in Clinical Trials (PDF204KB)
Yuki Ando,
09_E17 EWG
General principle on planning/designing
Multi-Regional Clinical Trials (PDF423KB)
Shuji Kamada,
10_E18 EWG
Genomic Sampling Methodologies for Future
Use (PDF304KB)
Yu Sakamoto,
Quality Topics

Session Chair:
Kazuhiro Okochi, JPMA
11_Q12 EWG
Technical and Regulatory Considerations for
Pharmaceutical Product Lifecycle
Management (PDF516KB)
Yasuhiro Kishioka,
12_M9 EWG
Biopharmaceutics Classification
System-based Biowaivers (PDF265KB)
Naomi Nagai,
  Closing Remarks Mitsuo Mihara,

*NIHS: National Institute of Health Sciences

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