ICHPharmaceutical Regulations in Japan

ICH Japan Symposium 2015
(The 32nd ICH Public Meeting)

An ICH regional public meeting entitled ICH Japan Symposium 2015 (The 32nd ICH public meeting) was held in Japan which took place at the Zendentsu Hall, Chiyoda-ku in Tokyo in July 23, 2015.

This public meeting aims to provide an opportunity to update to the public on the information of the progress made during the ICH meeting in Fukuoka in June 5-11, 2015 and on the status of the various ICH Guidelines including ICH Reform 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 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.

All the presentation materials used in the meeting is available in Japanese as below.
 Working Language: Japanese
 Simultaneous English-Japanese Translation: Not Available

Location: Zendentsu Hall,3-6, Kanda Surugadai,Chiyoda-ku, Tokyo, Japan
Date: July 23, 2015 10:00am - 4:35pm.

Program: ICH Japan Symposium 2015 (English) (PDF 34KB)

  Presentation Materials Speakers
Opening remarks Kurajiro Kishi,
JPMA
Future ICH: ICH Reform 01 Update on ICH Reforms (PDF 223KB) Toshiyoshi Tominaga,
PMDA
02 ICH Update in Fukuoka (PDF 564KB) Hironobu Saito,
JPMA
Topics for the Electronic Exchange of Information

Session Chair:
Manabu Inoue
- JPMA
Mihoko Okada
- MHLW(KUMW*)
03_ M2 EWG: Electronic Standards for the Transfer of Regulatory Information (PDF767KB) Katsuhiro Hashimoto,
JPMA
04_M8 EWG/IWG
   Electronic Common Technical document (eCTD) (PDF450KB)
Taku Watanabe,
PMDA
Safety Topics

Session Chair:
Kazuto Watanabe
- JPMA
Akiyoshi Nishikawa
- MHLW (NIHS*)
05_ S3A IWG: Q&As on the ICH Guideline on Note for Guidance on Toxicokinetics (PDF313KB) Yoshiro Saito,
MHLW(NIHS*)
06_S5 (R3) EWG: Revision of ICH Guideline on Detection of Toxicity to Reproduction for Medicinal Products and Toxicity to Male Fertility (PDF236KB) Michio Fujiwara,
JPMA
07_S9 IWG: Q&As on ICH Guideline on Nonclinical Evaluation for Anticancer Pharmaceuticals (PDF304KB) Dai Nakae,
MHLW (TUA*)
08_S11 EWG: ICH Guideline on Nonclinical Safety Testing in support of Development of Pediatric Medicines (PDF272KB) Kiyoshi Matsumoto,
JPMA
09_ M7 (R1) EWG: Addendum to ICH Guideline on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk (PDF534KB) Masamitsu Honma,
MHLW (NIHS)
Efficacy Topics

Session Chair:
Seiki Kanazawa
- JPMA
Yoshiaki Uyama
- PMDA
10_E6 (R2) EWG: Addendum to ICH Guideline on Good Clinical Practice (GCP)(PDF272KB) Satoshi Matsushita,
JPMA
11_ E9 (R1) EWG: Addendum to ICH Guideline on Defining the Appropriate Estimand for a Clinical Trial/Sensitivity Analyses (PDF599KB) Satoru Tsuchiya,
JPMA
12_ E11 (R1) EWG: Addendum to ICH Guideline on Pediatric Drug Development (PDF316KB) Katsuaki Sato,
JPMA
13_ E14 Discussion Group: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs(PDF358KB) Kaori Shinagawa,
PMDA
14_ E17 EWG: ICH Guideline on Multi-Regional Clinical Trials (PDF738KB) Yoko Aoi,
PMDA
15_ E18 EWG: ICH Guideline on Genomic Sampling Methodologies for Future Use (PDF386KB) Akihiro Ishiguro,
PMDA
16_ M4E (R2) EWG: Revision of CTD-Efficacy Guideline (PDF343KB) Yukiko Watabe,
JPMA
Quality Topics

Session Chair:
Tsuneo Okubo
– JPMA
Haruhiro Okuda
– MHLW (NIHS*)
17_ Q3C (R6) Maintenance EWG: Maintenance of the ICH Guideline for Residual Solvents (PDF186KB) Akihiko Hirose,
MHLW (NIHS)
18_ Q7 IWG: Q&As on ICH Guideline on Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (PDF786KB) Tetsuhito Takarada,
JPMA
19_Q11 IWG: Q&As on ICH Guideline on API Starting Materials(PDF124KB) Kenji Ozaki,
JPMA
20_Q12 EWG: ICH Guideline on Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management (PDF349KB) Yasuhiro Kishioka,
PMDA
  Closing Remarks Kurajiro Kishi,
JPMA

*KUMW: Kawasaki University of Medical Welfare
 NIHS: National Institute of Health Sciences
 TUA: Tokyo University of Agriculture

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