ICH Project The 34th ICH Public Meeting
Zendentsu Hall, Tokyo

July 21, 2016

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.

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

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

ICH Public Meetings