ICHPharmaceutical Regulations in Japan

The 31st ICH Public Meeting
(Nagai Kinen Hall, Tokyo)

The 31st ICH public meeting was held in Japan which took place at the Nagai Kinen Hall, Shibuya-ku in Tokyo in December 11, 2014.

This public meeting aims to provide an opportunity to update the public on the information of the progress made during the ICH meeting in Lisbon from November 8 to 13, 2014. At the beginning, we had presentations of the current discussion for ICH Reforms and recent development of ICH then move to the topics on the status of ICH Guidelines under development with Q & A session.

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
Nagai Kinen Hall,
2-12-15, Shibuya Shibuya-ku, Tokyo,
Japan
December 11, 2014   10:00 am ~4:50 pm

Program: The 31st ICH Public Meeting (English) (PDF 25KB)

  Presentation materials Speakers
  01_Recent Developments of ICH (PDF 437KB) Kurajiro Kishi, JPMA
Topics for the Electronic
Exchange of Information
02_E2B(R3)IWG
Revision of the Electric Submission of Individual Case Safety Reports (PDF 644KB)
Manabu Inoue, JPMA
03_M8 EWG/IWG
Electronic Common Technical document (eCTD) (PDF 444KB)
Taku Watanabe, PMDA
Safety Topics 04_S5(R3) informal WG
Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility (PDF 336 KB)
Michio Fujiwara, JPMA
05_S9 IWG
Q&As on Nonclinical Evaluation for Anticancer Pharmaceuticals (PDF 299 KB)
Chihiro Nishimura, JPMA
Efficacy Topics 06_E6(R2) EWG
Addendum to Good Clinical Practice (GCP) (PDF 510KB)
Seiki Kanazawa, JPMA
07_E9(R1) EWG
Addendum to Statistical Principles for Clinical Trials (PDF 507KB)
Satoru Tsuchiya, JPMA
08_E11(R1) EWG
Addendum to Pediatric Drug Development (PDF 370KB)
Masahiro Ozaki, JPMA
09_E17 EWG
Multi-Regional Clinical Trials (PDF 5,800KB)
Yoshiaki Uyama, PMDA
10_E18 EWG
Genomic Sampling Methodologies for Future Use (PDF 355KB)
Akihiro Ishiguro, PMDA
11_M4E(R2) EWG
Revision of CTD-Efficacy Guidelines (PDF 510KB)
Yukiko Komori, PMDA
Quality Topics 12_Q3D EWG/IWG
Guideline for Elemental Impurities (PDF 424KB)
Toshinori Higashi, PMDA
13_Q7 IWG
Q&As on Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (PDF 524KB)
Tetsuhiro Takarada, JPMA
14_Q12 EWG
Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management (PDF 182KB)
Yasuhiro Kishioka, PMDA

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