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Before

This page announces the reorganization of the ICH (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use). On October 23, 2015, a new ICH organization was established as a Swiss-based international non-profit entity. The new organization comprises a General Assembly, Management Committee, and expert working groups. Member organizations include regulatory authorities from Japan, the US, EU, Switzerland, and Canada, along with pharmaceutical industry associations. The WHO and IFPMA participate as observers. Japan's PMDA serves as Vice-Chair of the General Assembly and holds veto rights on major decisions. The ICH continues promoting international regulatory harmonization through guideline development for drug approval and post-market safety measures.

After

このページは、医薬品規制調和国際会議（ICH）が新しく法人として再編されたことを知らせています。新法人はスイス法に基づく非営利法人で、全世界の規制当局や製薬業界団体の参加を拡大し、薬事規制の国際調和を推進することを目指しています。新たな組織は、総会や管理委員会、専門家の作業部会で構成され、初代の副議長には日本のPMDAが選出されました。今後は、共通のガイドラインを作成し、医薬品の承認審査などにおける国際的な基準を確立していく計画です。