ICHPharmaceutical Regulations in Japan

The 39th ICH Public Meeting
(Zendentsu Hall, Tokyo)

The 39th ICH public meeting was held in Japan which took place at the Zendentsu Hall, Chiyoda-ku in Tokyo on December 14, 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 Charlotte from November 10 to 15, 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 220 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, Kansai Pharmaceutical Industries Association and Japan Pharmaceutical Association.

Working Language: Japanese
Simultaneous English-Japanese Translation: Not Available

Date Place
December 14, 2018   10:00 am ~4:50 pm Zendentsu Hall,
3-6, Kanda Surugadai, Chiyoda-ku, Tokyo,

Program: The 39th ICH Public Meeting (PDF 490KB)

Presentation materials Speakers
Opening remarks Akira Kawahara,
01_ICH activities – after 7th ICH meeting at Charlotte-  (PDF 935KB) Fumihito Takanashi,
02_ICH activities – Summary of the Charlotte Meetings from JPMA’ view points -
(PDF 1116KB)
Hironobu Hiyoshi,
03_Q2(R2)/Q14 EWG : Analytical Procedure Development and Revision of Q2(R1) Validation of Analytical Procedures (PDF 623KB) Yukio Hiyama,
04_Q13 EWG : Continuous Manugacturing of Drug Substances and Drug Products
(PDF 454KB)
Atsushi Aoyama,
05_E14/S7B IWG : Clinical and non-Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential (PDF 422KB) Kaori Shinagawa,
06_E8(R1) EWG : Revision of General Considerations for Clinical Trials (PDF 802KB) Mutsuhiro Ikuma,
07_ E9(R1) EWG : Addendum to Statistical Principles for Clinical Trials on Choosing Appropriate Estimands and Defining Sensitivity Analyses in Clinical Trials
(PDF 342KB)
Yuki Ando,
08_ E11A EWG : Pediatric Extrapolation (PDF 288KB) Shinichi Kijima,
09_E17 IWG : General principle on planning/designing Multi-Regional Clinical Trials(MRCT) training material (PDF 1576KB) Yasuto Otsubo,
10_ E19 EWG : Optimisation of Safety Data Collection  (PDF 390KB) Kinue Nishioka,
11_M11 EWG : Clinical electronic Structured Harmonized Protocol (CeSHarP)
(PDF 1269KB)
Motoki Mikami,
12_S1(R1) EWG : Revision of the Rodent Carcinogenicity Studies for Human Pharmaceuticals Guideline (PDF 500KB) Kumiko Ogawa,
13_S5(R3) EWG : Revision of S5 Guideline on Detection of Toxicity to Reproduction for Human Pharmaceuticals (PDF 1200KB) Kazushige Maki,
14_M7(R2) EWG : Addendum to Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk
(PDF 1406KB)
Masamitsu Honma,
15_M10 EWG : Bioanalytical Method Validation  (PDF 832KB) Daisuke Iwata,
Closing Remarks Shigeki Tsuda,

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