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出自识林

2014-11-06 Lachman CONSULTANTS

经过多年由FDA为已检查设施分配唯一的设施编号，FDA今日发布“行业指南：药品设施登记的唯一设施标识符（UFI）系统规范”程序指南，确定他们选择使用由邓白氏公司分配和管理的数据通用编号系统D-U-N-S（DUNS）码。

FDA根据指示卫生部（授权下属FDA）的FDASIA法案701和702节，为国内外药品设施登记指定UFI系统。FDA决定管理国内外药品设施登记的唯一设施标识符。DUNS码可免费获得。

FDA在指南中指出”指南反应了按照数据标准、信息技术和信息管理资源的当前思考。” FDA还表示，从电子药品登记和入录系统开始实施已经在使用DUNS码。获取DUNS码应提交的附加信息请见这里。

Lachman CONSULTANTS - Bob Pollock先生 2014-11-05
编译：识林-椒 2014-11-06

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Done and DUNS!
Written by Bob Pollock • November 05, 2014

After years of FDA assigning unique establishment numbers to FDA inspected facilities, the Agency has published a procedural Guidance today entitled, “Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration: Guidance for Industry”, identifying their choice of the Data Universal Numbering System D-U-N-S (DUNS) number, assigned and managed by Dun and Bradstreet.

FDA was directed by Sections 701 and 702 of FDASIA that direct the Secretary (and by delegation FDA) to specify the UFI system for registration of domestic and foreign drug establishments. The Agency decided to manage the unique facility identifier for registration of domestic and foreign drug establishments. The DUNS number can be obtained at no charge

FDA notes in the Guidance that the “guidance reflects current thinking in light of data standards, information technology, and information management resources.” The Agency also indicated that it has been using the DUNS number ever since the implementation of the electronic drug registration and listing system was put in place. A copy of the Guidance can be found here. The Agency refers you to additional information on obtaining a DUNS number here.