ICHPharmaceutical Regulations in Japan

ICH Japan Symposium 2018
(The 38th ICH Public Meeting)

An ICH regional public meeting entitled ICH Japan Symposium 2018 (The 38th ICH public meeting) was held in Japan which took place at the Zendentsu Hall, Chiyoda-ku in Tokyo on July 18, 2018.

This public meeting aims to provide an opportunity to update the public on the information of the progress made during the ICH meeting in Kobe from June 1 to 7, 2018. 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 210 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
July 18, 2018
10:00 am ~ 3:35 pm
Zendentsu Hall, 3-6, Kanda Surugadai, Chiyoda-ku, Tokyo, Japan
  Presentation Materials Speakers
Opening remarks Akira Kawahara,
JPMA
Movement of ICH 01_ICH activities
- Summary of the Kobe Meetings -
(PDF 1435KB)
Nobumasa Nakashima,
MHLW
02_ICH activities
- Summary of the Kobe Meetings from JPMA’ viewpoints -
(PDF 1007KB)
Hironobu Hiyoshi,
JPMA
Safety Topics

Session Chair:
Kazuto Watanabe, JPMA
03_S5 (R3) EWG
Revision of S5 Guideline on Detection of Toxicity to Reproduction for Human Pharmaceuticals
(PDF 915KB)
Kazushige Maki,
PMDA
04_S11 EWG
Nonclinical Safety Testing in support of Development of Pediatric Medicines
(PDF 351KB)
Takuya Nishimura,
PMDA
05_M10 EWG
Bioanalytical Method Validation
(PDF 784KB)
Daisuke Iwata,
PMDA
Topics for the Electronic
Exchange of Information

Session Chair:
Manabu Inoue, JPMA
06_E2B(R3)IWG / EWG
Electronic Transmission of Individual Case
Safety Reports (ICSRs)
(PDF 428KB)
Takashi Misu,
JPMA
07_M2 EWG
Electronic Standards for the Transfer of
Regulatory Information (ESTRI)
(PDF 565KB)
Mihoko Okada,
MHLW(*IDIAL)
08_M8 IWG / EWG
IWG/EWG eCTD
(PDF 252KB)
Ryo Saito,
PMDA
Efficacy Topics

Session Chair:
Seiki Kanazawa, JPMA
09_ E8(R1)EWG
Revision on General Considerations for Clinical Trials
(PDF 949KB)
Mutsuhiro Ikuma,
PMDA
10_ E9 (R1) EWG
Addendum to Statistical Principles for Clinical Trials on Choosing Appropriate Estimands and Defining Sensitivity Analyses in Clinical Trials
(PDF 395KB)
Yuki Ando,
PMDA
11_E11A EWG
Pediatric Extrapolation
(PDF 257KB)
Shinichi Kijima,
PMDA
12_E19 EWG
Optimisation of Safety Data Collection
(PDF 332KB)
Kinue Nishioka,
PMDA
13_M9 EWG
Biopharmaceutics Classification System-based Biowaivers
(PDF 326KB)
Yukiko Komori,
PMDA
  Closing Remarks Mitsuo Mihara,
JPMA

*Institute of Health Data Infrastructure for All

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