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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 Regulated Product Submissions ： ウィキペディア英語版 Regulated Product Submissions Regulated Product Submission (RPS) is a Health Level Seven (HL7) standard designed to facilitate the processing and review of regulated product information. RPS is being developed in response to performance goals that the U.S. Food and Drug Administration (FDA) is to achieve by 2012, as outlined in the Prescription Drug User Fee Act (PDUFA). In addition to the U.S., regulatory agencies from Europe, Canada, and Japan are at varying levels of interest and participation.〔 Currently, the second release of RPS is in development.〔 ==Goal of RPS== Authorities such as the FDA receive numerous submissions that address a variety of regulatory issues. The information contained in these submissions is divided into large numbers of files, both paper and electronic. Often, files in one submission are related to files in earlier submissions. Because the information is divided into numerous files sent over time, it can be difficult to efficiently process and review the information. While the general data layouts of all regulated products are the same, different product types have different lists of topics that must be addressed within the submission. Therefore, the goal of RPS is to create an HL7 XML message standard for submitting information to regulatory authorities. Each message includes the contents of a regulatory submission plus information such as metadata, which is necessary to process submissions. The (Refined Message Information Model ) (R-MIM) shows the structure of a message as a color-coded diagram. R-MIM diagrams are designed to capture all required information for the efficient processing and review of regulatory submissions and to explain what each message consists of. This makes RPS general enough to handle all regulated products while containing enough information to allow regulators to support structured review. 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「Regulated Product Submissions」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.