ICHPharmaceutical Regulations in Japan

The 34th ICH Public Meeting
(Zendentsu Hall, Tokyo)

The 34th ICH public meeting was held in Japan which took place at the Zendentsu Hall, Chiyoda-ku in Tokyo in July 21, 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 Lisbon from June 11 to 16, 2016. 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, 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
July 21, 2016   10:00 am ~4:15 pm

Program: The 34rd ICH Public Meeting (PDF 302KB)

  Presentation materials Speakers
  Opening remarks Hironobu Saito,
JPMA
  01_ICH Organizational Changes and Summary of ICH Meetings in Lisbon  (PDF 883KB) Fumihito Takanashi,
MHLW
02_ICH activities New Topic Discussion (PDF 344KB) Hironobu Saito,
JPMA
03_ICH activities Introduction to Industry Executive Council (IEC) (PDF 423KB) Masafumi Yokota,
JPMA
Safety Topics 04_S5 (R3) EWG Revision on Detection of Toxicity to Reproduction for Medicinal Products and Toxicity to Male Fertility (PDF 243 KB) Michio Fujiwara,
JPMA
05_S11 EWG Nonclinical Safety Testing in support of Development of Pediatric Medicines (PDF 417KB) Yuji Takahashi,
NIHS
Quality Topics 06_Q11 IWG Q&As on Selection and Justification of Starting Materials for the Manufacture of Drug Substances (PDF 810KB) Kazunori Takagi,
PMDA
07_Q12 EWG Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management (PDF 832KB) Masaaki Wada,
JPMA
Efficacy Topics 08_E6(R2)EWG Integrated Addendum Good Clinical Practice (PDF 424KB) Hazuki Takaura,
PMDA
09_ E9 (R1) EWG Addendum to Statistical Principles for Clinical Trials (PDF 653KB) Satoru Tsuchiya,
JPMA
10_E11(R1)EWG Addendum to Clinical Investigation of Medicinal Products in the Pediatric Population (PDF 465KB) Michiyo Sakiyama,
PMDA
Topics for the Electronic Exchange of Information 11_E2B(R3)IWG Q&As on Electronic Transmission of Individual Case Safety Reports (ICSRs) (PDF 302KB) Takashi Misu,
PMDA
12_M4E(R2)EWG Enhancing the Format and Structure of Benefit-Risk Information in ICH M4E(R1) Guideline (PDF 360KB) Katsuhiko Ichimaru,
PMDA
Developed Topics 13_S9 IWG Q&As on Nonclinical Evaluation for Anticancer Pharmaceuticals (PDF 300KB) Dai Nakae,
MHLW (TUA*)
14_ E17 EWG General principle on planning/designing Multi-Regional Clinical Trials(MRCT) (PDF 916KB) Yoshiaki Uyama,
PMDA
  Closing Remarks Mitsuo Mihara,
JPMA

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

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