医薬品規制調和国際会議（ICH）総会が開催されました ～３つのガイドラインを新たに採択、各国の薬事規制に取り込みへ～
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医薬品規制調和国際会議（ICH）総会が開催されました ～３つのガイドラインを新たに採択、各国の薬事規制に取り込みへ～
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This page reports on the ICH General Assembly held May 25-27, 2020, conducted via teleconference due to COVID-19. Key outcomes include the adoption of three guidelines: pediatric drug development, reproductive toxicity testing, and electronic Common Technical Document specifications. New topics agreed upon include revision of quality-related document guidelines and structured quality data submissions. Turkey's pharmaceutical agency became a new member, bringing ICH membership to 17 organizations. The PMDA International Department Director's term was extended for one year. The next meeting is scheduled for November 14-18 in Athens.
