ICHPharmaceutical Regulations in Japan

The 40th ICH public meeting
(Zendentsu Hall, Tokyo)

The 40th ICH public meeting was held in Japan which took place at the Zendentsu Hall, Chiyoda-ku in Tokyo on July 17, 2019.

This public meeting aims to provide an opportunity to update the public on the information of the progress made during the ICH meeting in Amsterdam from June 1 to 6, 2019. 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 370 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
July 17, 2019   10:00 am ~5:50 pm Zendentsu Hall,
3-6, Kanda Surugadai, Chiyoda-ku, Tokyo,
Japan
Presentation materials Speakers
Opening remarks Shigeki Tsuda,
PMRJ
01_ICH activities (2019/07) ICH Amsterdam Meeting Report (PDF 1369KB) Ryo Iwase,
MHLW
02_ICH activities
- Summary of the Amsterdam Meetings from JPMA’ view points - (PDF 1351KB)
Hironobu Hiyoshi,
JPMA
03_Q2(R2)/Q14 EWG : Analytical Procedure Development and Revision of Q2(R1)Validation of Analytical Procedures (PDF 1339KB) Keisuke Inoue,
JPMA
04_Q3D(R2) EWG : Revision of Q3D(R1) for cutaneous and transdermal products 
(PDF 461KB)
Masayuki Mishima,
JPMA
05_Q12 EWG : Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management (PDF 605KB) Masaaki Wada,
JPMA
06_ Q13 EWG : Continuous Manugacturing of Drug Substances and Drug Products 
(PDF 247KB)
Atsushi Aoyama,
PMDA
07_M9 EWG :
Biopharmaceutics Classification System-based Biowaivers (PDF 654KB)
Hideaki Kuribayashi,
PMDA
08_E8(R1) EWG : Revision of General Considerations for Clinical Trials (PDF 1350KB) Mutsuhiro Ikuma,
PMDA
09_ E9(R1) EWG : Addendum to Statistical Principles for Clinical Trials on Choosing Appropriate Estimands and Defining Sensitivity Analyses in Clinical Trials 
(PDF 283KB)
Yuki Ando,
PMDA
10_ E11A EWG : Pediatric Extrapolation (PDF 244KB) Shinichi Kijima,
PMDA
11_E17 IWG : General principle on planning/designing Multi-Regional Clinical Trials(MRCT) training material (PDF 2305KB) Yasuto Otsubo,
PMDA
12_M11 EWG : Clinical electronic Structured Harmonized Protocol (CeSHarP) 
(PDF 1155KB)
Ken Sakushima,
PMDA
13_S5(R3) EWG : Revision of S5 Guideline on Detection of Toxicity to Reproduction for Human Pharmaceuticals (PDF 1231KB) Kazushige Maki,
PMDA
14_S11 EWG : Nonclinical Safety Testing in support of Development of Pediatric Medicines(PDF 386KB) Takuya Nishimura,
PMDA
15_M7(R2) EWG : Addendum to Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk (PDF 1565KB) Yosuke Demizu,
NIHS
16_E14/S7B IWG : Clinical and non-Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential (PDF 371KB) Satoshi Tsunoda,
PMDA
17_E2B(R3) EWG / IWG :
Electronic Transmission of Individual Case Safety Reports (ICSRs) (PDF 368KB)
Takashi Misu,
PMDA
18_M2 EWG : Electronic Standards for the Transfer of Regulatory Information (ESTRI) 
(PDF 629KB)
Daisuke Sato,
PMDA
Closing Remarks Masafumi Yokota,
JPMA

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