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,
Japan

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

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

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