药品企业注册用唯一设施识别（UFI）系统的标准（中英文）

Guidance for Industry

Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration

Additional copies are available from: Office of Communications Division of Drug Information, WO51, Room 2201 Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave., Silver Spring, MD 20993 Phone: 301-796-3400; Fax: 301-847-8714 druginfo@fda.hhs.gov

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm

and/or Office of Communication, Outreach and Development, HFM-40 Center for Biologics Evaluation and Research Food and Drug Administration 1401 Rockville Pike, Rockville, MD 20852-1448

http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm (Tel) 800-835-4709 or 301-827-1800 and/or Communications Staff, HFV-12 Center for Veterinary Medicine Food and Drug Administration 7519 Standish Place, Rockville, MD 20855 (Tel) 240-276-9300

http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm

and/or Office of Policy Office of the Commissioner Food and Drug Administration 10903 New Hampshire Ave. Silver Spring, MD 20993 Phone: 301-796-4830

U.S. Department of Health and Human Services

Food and Drug Administration Office of the Commissioner (OC)

Center for Drug Evaluation and Research (CDER)

Center for Biologics Evaluation and Research (CBER)

Center for Veterinary Medicine (CVM)

Office of Regulatory Affairs (ORA)

September 2013

Procedural

TABLE OF CONTENTS 目录

I. INTRODUCTION 介绍

II. BACKGROUND 背景

A. Food and Drug Administration Safety and Innovation Act 食品药品管理安全和创新法案

B. Scope of this Guidance 本指南范围

III. SPECIFICATION OF THE UNIQUE FACILITY IDENTIFIER SYSTEM 唯一场所识别系统的标准

Guidance for Industry[1]

行业指南

Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration

药品企业注册用唯一设施识别（UFI）系统的标准

This draft guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. 本指南草案，当最终定稿时，代表食品药品管理局（FDA）当前对于此主题的思考。本指南并未创建或赋予任何人任何特权，也未强制FDA或公众。你可以采用法中使用和法规要求的替代方法。如果你想讨论替代的方法，请联系FDA负责本指南实施的相关人员。如果你不知道该联系谁，请拨打本指南台头列出的相应电话号码。

I. INTRODUCTION 介绍

This guidance specifies the unique facility identifier (UFI) system for registration of domestic and foreign drug establishments. This guidance is intended to address provisions set forth in section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA) (Public Law 112-144), regarding the specification of the UFI system.

本指南指定唯一设施识别（UFI）系统用于国内和国际药品企业登记。本指南目的是说明在联邦食品药品和化妆品法案（FD&C Act）(21 U.S.C. 360)中第510部分的条款，该条款由食品药品管理安全和创新法案（FDASIA）（公共法112-114）修订了关于UFI系统的规定。

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

FDA的指南文件，包括本指南，并未建立法定强制责任。在指南中描述了当局现在关于一个主题的思考，除引用的特定法规或强制要求外，应作为推荐来看。单词“should”在官方指南中表示某件事情是建议或推荐，但不是强制要求。

II. BACKGROUND 背景

A. Food and Drug Administration Safety and Innovation Act 食品药品管理安全和创新法案

In July 2012, FDASIA was signed into law. Sections 701 and 702 of FDASIA direct the Secretary to specify the UFI system for registration of domestic and foreign drug establishments. Once the UFI system is specified, section 510 of the FD&C Act, as amended, requires that each initial and annual drug establishment registration include a UFI (21 U.S.C. 360(b), (c), and (i)).

在2012年7月，FDASIA签署成为法律。FDASIA的第701和702部分要求秘书处指定UFI系统用于国内和国外药品企业登记。一旦指定UFI系统，FD&C法案的第510部分修订内容，要求每个首次和年度企业登记包括一个UFI（21 U.S.C. 360(b), (c), and (i)）。

       B. Scope of This Guidance 本指南范围

       This guidance is intended solely to address the provisions in sections 701 and 702 of FDASIA that direct the Secretary to specify the UFI system for registration of domestic and foreign drug establishments. This guidance reflects current thinking in light of data standards, information technology, and information management resources. As these variables change over time, the FDA may revisit this guidance and the specification made in section III of this guidance.

本指南目的只是说明在FDASIA的第701和702部分中的条款，其中指定采用UFI系统用于国内和国外制药场所登记。本指南反映了目前关于数据标准、信息技术和信息管理资源的思考。由于这些情况会随时间而变化，FDA可能会再审本指南，以及其中第III部分的标准。

       III. SPECIFICATION OF THE UFI SYSTEM 唯一设施识别系统要求

  For drug establishment registration, FDA is specifying the following UFI System. At this time, FDA’s preferred UFI for a drug establishment is the Data Universal Numbering System D-U-N-S (DUNS) number, assigned and managed by Dun and Bradstreet. The FDA has been using the DUNS number as a registration number for drug establishments since the implementation of electronic drug registration and listing (for information on the electronic submission of registration and listing data, see http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm).

对于制药场所登记，FDA指定以下的UFI系统。目前，FDA倾向于采用全球编号数据系统（邓白氏）编号，由邓白氏赋予和管理。自从实施电子药品注册和列单管理（关于电子注册申报和列单数据信息，参见相关网站）以来，FDA已采用邓白氏编号作为登记编号，用于制药场所登记。

  Currently, the FDA finds the DUNS number appropriate to meet Agency needs for a data standard for drug establishment registration UFI. The DUNS number is available free of charge to all drug establishments, and further information is available on the FDA Web site athttp://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162544.htm. If you want to use an alternative identifier for your drug establishment, contact FDA via email at eDRLS@fda.hhs.gov.

现在，FDA发现邓白氏编号符合当局建立制药工厂标准数据登记的要求。所有制药场所均可以免费获得邓白氏编号，更多信息可以参见FDA网站。如果你想要为你的制药场所采用另一种替代的识别号，请通过电子邮件与FDA联系。

来源：http://zhuyujiao1972.blog.163.com/blog/static/98694727201310213245167/