ICHPharmaceutical Regulations in Japan

The 36th ICH Public Meeting
(Zendentsu Hall, Tokyo)

The 36th ICH public meeting was held in Japan which took place at the Zendentsu Hall, Chiyoda-ku in Tokyo on June 30, 2017.

This public meeting aims to provide an opportunity to update the public on the information of the progress made during the ICH meeting in Montreal from May 27 to June 1, 2017. 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 240 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 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 Date
Zendentsu Hall,
3-6, Kanda Surugadai, Chiyoda-ku, Tokyo,
June 30, 2017   10:00 am ~4:35 pm

Program: The 36th ICH Public Meeting (PDF 298KB)

Presentation materials Speakers
Opening remarks Akira Kawahara,
01_ICH activities – Summary of the Montreal Meetings-   (PDF 642KB) Fumihito Takanashi,
02_ICH activities – Summary of the Montreal Meetings from JPMA’ view points - (PDF 1402KB) Hironobu Hiyoshi,
03_E9 (R1) EWG: Addendum to Statistical Principles for Clinical Trials on Choosing Appropriate Estimands and Defining Sensitivity Analyses in Clinical Trials (PDF 224KB) Yuki Ando,
04_E17 EWG: General principle on planning/designing Multi-Regional Clinical Trials(MRCT) (PDF 513 KB) Shuji Kamada,
05_E19 informal WG: Optimisation of Safety Data Collection (PDF 505KB) Kinue Nishioka,
06_M9 EWG: Biopharmaceutics Classification System-based Biowaivers (BCS) (PDF 291KB) Yutaka Takahashi,
07_E2B(R3)IWG : Q&As on Electronic Transmission of Individual Case Safety Reports (ICSRs) (PDF 793KB) Manabu Inoue,
08_M2 EWG: Electronic Standards for the Transfer of Regulatory Information (ESTRI) (PDF 876KB) Mihoko Okada,
09_ Q11 IWG: Selection and Justification of Starting Materials for the Manufacture of (synthetic) Drug Substances (PDF 692KB) Kazunori Takagi,
10_Q12 EWG: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management (PDF 853KB) Yasuhiro Kishioka,
11_E11(R1) EWG: Clinical Investigation of Medicinal Products in the Pediatric Population (PDF 299KB) Michiyo Sakiyama,
12_S1 EWG: Revision of the Rodent Carcinogenicity Studies for Human Pharmaceuticals (PDF 302KB) Shigeru Hisada,
13_S5(R3) EWG: Revision on Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility (PDF 451KB) Masao Horimoto,
14_ S11 EWG: Nonclinical Safety Testing in Support of Development of Paediatric Medicines (PDF 267KB) Kiyoshi Matsumoto,
15_ M10 EWG: Bioanalytical Method Validation (PDF 946KB) Seiji Tanaka,
Closing Remarks Mitsuo Mihara,

*TRI: Translational Research Informatics Center
*CIS: Chiba Institute of Science

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