ICHPharmaceutical Regulations in Japan

The 33rd ICH Public Meeting
(Zendentsu Hall, Tokyo)

The 33rd ICH public meeting was held in Japan which took place at the Zendentsu Hall, Chiyoda-ku in Tokyo on January 15, 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 Jacksonville from December 5 to 10, 2015. At the beginning, we had presentations about the establishment of the ICH Association then move to the topic on the status of various 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
Zendentsu Hall,
3-6, Kanda Surugadai, Chiyoda-ku, Tokyo,
Japan
January 15, 2016 10:00 am ~4:25 pm

Program: The 33rd ICH Public Meeting (English) (PDF 28KB)

  Presentation materials Speakers
  Opening remarks Akira Kawahara, JPMA
  01_Overview of ICH and its reform (PDF 693KB) Fumihito Takanashi, MHLW
02_ICH Update (PDF 1013KB) Hironobu Saito, JPMA
Topics for the Electronic Exchange of Information 03_ M2 EWG: Electronic Standards for the Transfer of Regulatory Information (PDF 548 KB) Katsuhiro Hashimoto, JPMA
04_M8 IWG/EWG:The Electronic Common Technical Document: eCTD (PDF 266 KB) Taku Watanabe, PMDA
Quality Topics 05_Q11 IWG: Q&As on API Starting Materials (PDF 641KB) Kenji Ozaki, JPMA
06_Q12 EWG: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management (PDF 653KB) Yasuhiro Kishioka, PMDA
Efficacy Topics 07_ E9 (R1) EWG: Addendum to Defining the Appropriate Estimand for a Clinical Trial/Sensitivity Analyses (PDF 579KB) Satoru Tsuchiya, JPMA
08_ E14 IWG: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs (PDF 421KB) Kaori Shinagawa, PMDA
09_ E17 EWG: Multi-Regional Clinical Trials (MRCT) (PDF 265KB) Shuji Kamada, PMDA
10_ E18 EWG: Genomic Sampling and Management of Genomic Data (PDF 345KB) Akihiro Ishiguro, PMDA
Safety Topics 11_ S1 EWG: Rodent Carcinogenicity Studies for Human Pharmaceuticals (PDF 396KB) Akiyoshi Nishikawa MHLW(NIHS*)
12_S5 (R3) EWG: Revision on Detection of Toxicity to Reproduction for Medicinal Products and Toxicity to Male Fertility (PDF 229KB) Michio Fujiwara, JPMA
13_S9 IWG: Q&As on Nonclinical Evaluation for Anticancer Pharmaceuticals (PDF 296KB) Dai Nakae, MHLW (TUA*)
14_S11 EWG: Nonclinical Safety Testing in support of Development of Paediatric Medicines (PDF 253KB) Kiyoshi Matsumoto, JPMA
  Closing Remarks Mitsuo Mihara, JPMA

* NIHS: National Institute of Health Sciences
 TUA: Tokyo University of Agriculture

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