ICH Project
The Foundation participates in the International Conference on Harmonization of Pharmaceutical Regulations (ICH) and conducts activities to speed up and improve the efficiency of drug development through the creation of common guidelines. In addition, the Foundation will hold ICH immediate debriefing sessions and guideline briefing sessions, etc., and strive to disseminate information on ICH.
ICH is an abbreviation for International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.
ICH is a joint initiative of drug regulatory authorities and representatives of the pharmaceutical industry. Since its establishment in 1990 and its reorganization on October 23, 2015, ICH has steadily evolved to respond to the globalization of drug development, regulation, and distribution, and the number of member organizations continues to increase.
The objectives of ICH are to ensure the timely and continuous availability of new medicines to patients, to avoid unnecessary duplication of human clinical trials, to ensure the efficient development, registration, and manufacture of safe, effective, and high-quality medicines, and to reduce animal testing without adversely affecting the assessment of safety and efficacy. To promote public health by facilitating international harmonization of technical requirements to reduce the use of animal studies without adversely affecting the assessment of safety and efficacy.
Announcements and Updates
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ICH Project
ICH Q3E "Draft Guideline for Extractables and Eluates of Drugs" Information Meeting" is now available.
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ICH Project
ICH Project Chair Yokota was interviewed by Nikkan Yakugyo.
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ICH Project
ICH M4Q(R2) "Guideline for Preparation of CTD-Quality Document (Draft)" Briefing Session" is now available.
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ICH Project
ICH E21 "Inclusion of Pregnant and Lactating Women in Clinical Trials (Draft)" Information Session" is now available.
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ICH Project
The report of "ICH Madrid Meeting" is available.
ICH Project Content
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Implementation Plan
The implementation plan for this fiscal year is posted.
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List of Immediate Briefing Sessions
This is a report on the progress of the guideline discussed at the biannual ICH Steering Committee and Expert Working Group Meetings.
The schedule, program, etc. are available. -
International Conference
The contents of the international meetings, where the results of ICH are presented and discussed, are introduced.
The program, meeting results, minutes, etc. are posted. -
Guideline Briefing Session
Briefing session on the draft guidelines discussed at the ICH.
Program, documents, etc. are available. -
ICH Guidelines and Other Related Documents (Japanese translation, etc.)
Japanese and English translations of documents related to the ICH Guidelines and other guidelines are posted to deepen understanding and promote their implementation.
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Announcement from ICH Project
ICH project announcements, reports, etc. are posted here.