ICH Project
JPMA participates in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and contributes to faster and more efficient drug development through the development of harmonized guidelines. We also organize ICH Public Meetings and Guideline Workshops to share information and raise awareness.
The ICH stands for The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a unique forum where 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 grow.
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: avoiding unnecessary duplication of clinical trials in humans; promoting the efficient development, registration, and manufacture of safe, effective, and quality medicinal products; and promoting international harmonization of technical requirements to reduce animal testing without adversely affecting safety and efficacy assessments.
Notices and Updates
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ICH Project
Report on "ICH Singapore Meeting" is now available.
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ICH Project
ICH Q3E Guideline Workshops on "Draft Evaluation and Control of Extractables and Leachables of Pharmaceutical and Biological Products" are now available.
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ICH Project
ICH Project Chairperson Mr. Yokota was interviewed by Nikkan Yakugyo.
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ICH Project
ICH M4Q(R2) "Guideline Workshops on CTD-Quality Documentation Procedure (Draft)" 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.
ICH Project Content
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Implementation Plan
The implementation plan for this fiscal year is posted.
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Public Meetings
This page provides information on public meetings related to the progress of guidelines discussed at the biannual ICH Management Committee and Expert Working Group meetings. Details such as schedules and programs are available here.
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Guideline Workshops
These workshops provide explanations of draft guidelines discussed within ICH. Programs and related materials are available.
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ICH Guidelines and Related Documents (Japanese Translation, etc.)
Japanese and English translations of the ICH Guidelines and other related documents are posted to deepen understanding of the Guidelines and promote their implementation.
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Announcements from ICH Project
ICH Project announcements and meeting reports are posted here.
