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翻訳と辞書　辞書検索 [ 開発暫定版 ] スポンサード リンク International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ： ウィキペディア英語版 International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use The International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of pharmaceutical product registration. The purpose of ICH is to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines by recommending ways to achieve greater harmonisation in the interpretation and application of technical guidelines and requirements for product registration. Harmonisation would lead to a more economical use of human, non-human animal and material resources, and the elimination of unnecessary delay in the global development and availability of new medicines while maintaining safeguards on quality, safety, and efficacy, and regulatory obligations to protect public health. ICH guidelines have been adopted as law in several countries, but are only used as guidance for the U.S. Food and Drug Administration. ==History== In the 1980s, what is today the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation; ICH was created in April 1990 at a meeting in Brussels. International Conference on Harmonisation is now changed to International Council for Harmonisation and now it is a legal entity of Switzerland. On 23rd of October 2015 ICH conducted their initial meeting of their new assembly.〔()〕 抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』 ■ウィキペディアで「International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use」の詳細全文を読む スポンサード リンク 翻訳と辞書 : 翻訳のためのインターネットリソース Copyright(C) kotoba.ne.jp 1997-2016. All Rights Reserved.