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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 Electronic common technical document ： ウィキペディア英語版 Electronic common technical document The Electronic Common Technical Document (eCTD) is an interface for the pharmaceutical industry to agency transfer of regulatory information. The content is based on the Common Technical Document (CTD) format. It was developed by the International Conference on Harmonisation (ICH) Multidisciplinary Group 2 Expert Working Group (ICH M2 EWG). On May 5, 2015, the U.S. Food & Drug Administration published a final, binding guidance document〔(【引用サイトリンク】url=http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM333969.pdf )〕 requiring certain submissions in electronic (eCTD) format within 24 months. The projected date for mandatory electronic submissions is May 5, 2017 for New Drug Applications (NDAs), Biologic License Applications (BLAs), Abbreviated New Drug Applications (ANDAs) and Drug Master Files (DMFs). To date, more than 600,000 eCTD sequences have been submitted to the FDA.〔(【引用サイトリンク】url=http://www.globalsubmit.com/Services/Migration )〕 == Pharmaceutical point of view == The eCTD has five modules: # Administrative information and prescribing information # Common technical document summaries # Quality # Nonclinical study reports # Clinical study reports A (full table of contents ) could be quite large. There are two categories of modules: * Regional module: 1 (different for each region; i.e., country) * Common modules: 2–5 (common to all the regions) The CTD defines the content only of the common modules. The contents of the Regional Module 1 are defined by each of the ICH regions (USA, Europe and Japan). 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「Electronic common technical document」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.