FDA行业指南草案 药品企业注册用唯一设施识别（UFI）系统的标准（中英文）

巴西木

201309 FDA行业指南草案 药品企业注册用唯一设施识别（UFI）系统的标准（中英文）------翻译人：Julia

Guidance for Industry

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

DRAFT GUIDANCE

This guidance document is being distributed for comment purposes only.

Comments and suggestions regarding this draft document should be submitted within 60 days of publication in theFederal Register of the notice announcing the availability of the draft guidance. Submit electronic comments tohttp://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.

For questions regarding this draft document contact Paul Loebach eDRLS@fda.hhs.gov. U.S.

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, seehttp://www.fda.gov/ForIndustry/D ... abeling/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/D ... ling/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。

以下内容来自http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162544.htm

Business Entity Identifiers 业务实体识别

Business Entity Identifiers

Source: Dun and Bradstreet D-U-N-S Number

Dun and Bradstreet D-U-N-S Number OID: 1.3.6.1.4.1.519.1

DUNS Numbers can be obtained, or DUNS information modified, through D&B using the basic service (no cost) http://www.dnbgov.com/federal_compliance/fda/DUNSrequest/requestGuide.html or using the expedited service (nominal fee) at http://www.dnbgov.com/federal_compliance/fda/DUNSrequest/

通过邓白氏基本服务（免费），可以申请获得邓白氏编号，或修订邓白氏信息，或使用加速服务（名义费用）。

以下内容来自http://www.dnb.com/government/duns-request/duns-request-guide.html

Obtain a Free D-U-N-S? Number and/or Modify an Existing D-U-N-S? Number免费获得邓白氏编号和/或修订已有邓白氏编号

D&B’s worldwide database currently covers over 225 million business locations, which means that your entity may already have a D-U-N-S? Number assigned to it.

邓白氏全球数据库现在登记有超过225,000,000业务单位信息，也就是说，可能你的公司已经被赋予了一个邓白氏编号。

For U.S. Locations 美国本土设施

To determine whether your facility has a D-U-N-S? Number already or you need to obtain one, please use the D&B iUpdate service. iUpdate is D&B's Internet-based service that allows business principals to view, print, and request updates for their company information.  iUpdate also has a search function that allows you to search for and obtain the D-U-N-S? Numbers of your business location(s).

要知道你的场所是否已经注册了邓白氏编号，或者如果你需要申请一个新的邓白氏编号，请使用邓白氏“我的更新”服务。“我的更新”是邓白氏网络服务，允许业务部门进行浏览、打印，为其公司信息申请更新。“我的更新”还具有搜索功能，你可以通过它搜索到你的公司信息，或为你的公司申请邓白氏编号。

1.              Access iUpdate here.

进入“我的更新”

2.              If you are already registered in iUpdate, login and you can access your location’s or locations’ profile(s). Your D-U-N-S? Number will appear as part of the profile(s) on your establishment(s) and you can disregard the remaining steps in this guide.  If you are not registered in iUpdate, please select “Get a D-U-N-S? Number” in the bottom left corner of the page.

如果你已经注册了“我的更新”，登录，进入你公司信息所在页面或公司的概况。你的邓白氏编号会作为你的单位的概况的一部分出现，你可以忽略本指南中其它的步骤。如果你没有在“我的更新”注册，请选择页面左下角“获得一个邓白氏编号”。

3.              Answer “No” when asked: “Are you currently attempting to do business with or receive funds from a U.S. Government Agency?”  If you are a government contractor registered in SAM (formerly known as CCR), answer “Yes.”  You will be redirected to the application for businesses seeking to enter into contracts with the Federal Government to provide goods and services.

当被问到“你现在想与美国政府机构开始业务或从美国政府收到基金”，选择“否”。如果你是在SAM（以前的CCR）注册的政府合同商，选择“是”。页面会转到业务搜寻申请，进入联邦政府提供商品和服务的合同。

4.              The search function on the left-hand side of the page will allow you to search for your business location using its name, city, and state.  A list of search results will appear on the right-hand side of the page.

页面左手的搜索功能可以用于输入名称、城市和州，来搜索你的业务单位。在页面右手边会出现搜索结果的清单。

If your location is already in D&B’s database, it will appear here.  Select your establishment from the list and follow the on-screen instructions to register in iUpdate.  You will be asked a series of questions to confirm your own identity and your connection to the company whose records you are accessing.  Please note that D&B does not own, collect, or store your personal data; D&B uses commercially available individual identity matching technology to ensure that your identity is not being used fraudulently.  Once you are registered in iUpdate, you will be allowed to view your location’s D-U-N-S? Number and access and update your business’s information.

如果你的公司信息已经出现在邓白氏数据库，则网页上出现相关信息。从清单中选择你的公司，按屏幕提示操作，在“我的更新”中注册。系统会问你一些问题，以确认你自己的身份，你与所搜寻的公司的关系。请注意，邓白氏并不拥有、收集或存贮你的个人信息，邓白氏采用相关技术对身份进行识别，以保证你的身份不会被冒充。一旦你在“我的更新”中注册，你就可以浏览你的公司的邓白氏编号，进入并更新你的公司信息。

If your business did not appear in the list of search results, first check the information you entered into the search.  If this information is correct and your business still does not appear in the results field, your establishment is missing from D&B’s database.  Click on the “Get a D-U-N-S? Number” arrow in the bottom left-hand corner of the page and follow the on-screen instructions.  You will need the following information to obtain a D-U-N-S? Number:

如果你的业务在查询结果里找不到，首先需要检查你输入查询的信息是否正确。如果信息正确，你的业务还是找不到，则你的公司不在邓白氏数据库内。点击页面左下角“获得邓白氏编号”箭头，按页面指示操作。你可能需要以下信息来获得一个邓白氏编号。

Your Contact Information 你的联系信息

·                         First Name

·                         名

·                         Last Name

·                         姓

·                         Title at this Business

·                         职务

·                         Business Email Address

·                         公务邮件地址

·                         Business Telephone Number

·                         公务电话号码

Your Identity Validation Details 你的识别验证详细信息

·                         Physical Home Address

·                         家庭地址

·                         Home City

·                         家庭所在城市

·                         Home State

·                         家庭所在州

·                         Home Country

·                         家庭所在国家

·                         Home Telephone Number

·                         家庭电话号码

·                         Home Zip

·                         家庭邮编

Company Information 公司信息

·                         Name of Business (Full Legal Name)

·                         公司名称（法定名称全名）

·                         Business Address (Including Suite or Floor #)

·                         营业地址（包括楼号、楼层）

·                         City, State, Zip Code

·                         城市，州，邮编

·                         Local Phone Number

·                         本地电话号码

·                         Legal Structure of the Business (Corporation, Partnership, etc.)

·                         营业法定组织（公司、合伙等）

·                         Year Business Started

·                         开始营业年份

·                         Executive Principal (First and Last Name, Title, Email Address)

·                         执行董事（姓，名，职务，邮件地址）

·                         Antecedents (Name, Year of Birth)

·                         前任（姓名、出生年份）

·                         Select SIC/NAICS Code(s) (e.g. Drug Manufacturer)

·                         选择SIC/NAICS代码（例如，药品生产商）

·                         Total Number of Employees (Including Principals, and Part-time)

·                         雇员总数（包括主要领导和兼职人员）

You will receive a confirmation e-mail from D&B with any additional information required to obtain your entity’s D-U-N-S? Number and may be contacted by D&B to verify your information.  There is no charge for this service.  Typical responses for obtaining a D-U-N-S Number for a U.S.-based establishment come within 20 business days.  If you need a D-U-N-S? Number sooner, please use the Expedited D-U-N-S? Request Service found here.

你会收到邓白氏发出的确认邮件，其中会告诉你获得你的实体的邓白氏编号所需的其它信息，或者是邓白氏联系以确认你的信息。该服务不收费。一般在美国境内的公司会在20个工作日内收到回复。如果你需要更快地获得邓白氏编号，请使用快速邓白氏申请服务。

If you experience problems with the iUpdate service, please call 1-800-234-3867.  When prompted, ask about “getting a D-U-N-S?Number.”

如果你在更新服务时碰到问题，请致电1-800-234-3867，听到提示时，咨询“关于邓白氏编号”即可。

For Non-U.S. Locations 非美国本土设施

Entities outside the United States should go to their individual country D&B websites to find information on obtaining a D-U-N-S? Number in that specific country.  From www.dnb.com, select the country or region where your entity is based from the list in the top right-hand corner and find the information on getting a D-U-N-S? Number specifically tailored to your country or region.  Return time and cost for each request vary by country.

非美国本土的实体需要登录其所在国家的邓白氏网站，找到其中在本国获得邓白氏编号的信息。从www.dnb.com中右上角列表选择你的实体所在国家或地区，找到你所在国家或地区的邓白氏编号对应信息。每个申请所需的回复时间和费用因国家不同而异。

Below are the links to a number of countries’ and regions’ D-U-N-S? Number Request pages:

以下是各国和地区邓白氏编号申请网址

·                         Africa

·                         Australia

·                         Belgium

·                         Brazil

·                         Canada

·                         China

·                         Czech Republic

·                         Denmark

·                         France (email request)

·                         Germany

·                         Hong Kong

·                         Hungary

·                         India

·                         Indonesia

·                         Ireland

·                         Italy

·                         Japan

·                         Latin America and the Caribbean

·                         Middle East

·                         Netherlands

·                         Singapore

·                         Sweden

·                         South Asia

·                         Taiwan

·                         Turkey

·                         United Kingdom

以下内容来自http://www.dnb.com/government/duns-request.html

Dun & Bradstreet - FDA DUNS Request邓白氏—FDA邓白氏申请

Tel: (800) 424-2495

In support of the U.S. Food and Drug Administration regulatory guidance to industry for providing electronic submissions for Drug Establishment Registration and Drug Listing as well as Self-Identification, Dun & Bradstreet (D&B) is making available a new expedited DUNS Request Service.

为了支持美国FDA行业法规指南，为药品企业注册和药品清单以及自我识别提供电子提交服务，邓白氏提供新的快速邓白氏申请服务。

Expedited DUNS Request Service 快速邓白氏申请服务

What is the expedited DUNS Request service? 什么是快速邓白氏申请服务？

Allows you to request D-U-N-S Numbers for your own business establishments or for your suppliers, U.S. agents, or importers.

让你为自己的业务设施或你的供应商、美国代理或进口商申请一个邓白氏编号。

The Data Universal Numbering System (DUNS?) Number is a unique nine-digit identification number provided by D&B. The DUNS? Number is randomly issued, never used twice and is site specific.  Each distinct physical location of an entity is assigned its own DUNS Number worldwide.

全球编号数据系统（邓白氏）编号是一个唯一的9位数识别号码，它由D&B公司提供。邓白氏编号随机发放，不会重复，对应唯一的场所。每个具有物理位置的实体会获得自己在全球唯一的一个邓白氏编号。

Requesting a DUNS? Number is a quick and easy process.  It is the responsibility of the pharmaceutical company to obtain the existing DUNS? Number (or to take the steps required to request a new DUNS? Number) for their manufacturing establishments, suppliers, U.S. agents and/or importers.

申请邓白氏编号是一个快速简易的过程。制药公司有义务为其生产场所、供应商、美国代理和/或进口商获得已有的邓白氏编号（或采取行动申请一个新的邓白氏编号）。

The following information is needed to request a DUNS? Number:

申请邓白氏编号需要以下信息

·                        Legal Company Name

·                        公司法定名称

·                        Tradestyle or Doing-Business-As-Company Name

·                        贸易方式或公司从事业务名称

·                        Physical Address, City, State/Province and Postal Code

·                        地址，城市，州/省和邮编

·                        Telephone Number

·                        电话号码

·                        Highest ranking official at establishment

·                        设施最高级领导

·                        Line of Business

·                        业务线

The DUNS? Request Service is available for a fee of $14.95 per establishment look-up (plus applicable sales tax) and does not require a commitment to a D&B subscription. All charges will be applied to a customer provided credit card. There is not a minimum or maximum order requirement.

邓白氏编号申请服务费用为每个设施查询$14.95（加适用的销售税），不需要D&B会员费。所有费用适用于采用信用卡付费的客户。没有最低或最高费用要求。

How long does it take? 要花多长时间？

Request on a U.S. establishment为美国本土设施申请编号
Typically up to 10 business days 一般最多10个工作日

Request on a non-U.S. establishment 为美国本土以外设施申请编号
Typically up to 20 business days 一般最多20个工作日

Some requests may require interaction with the local country registrar.

有些申请可能需要与本国注册机构沟通。

How do I get started? 如何着手？

Click Here

Alternatively, the following options are available:

也可以通过以下方式进行

1.                  If you are a D&B contract customer, contact your D&B representative to request company D-U-N-S Numbers.

如果你是一个D&B合同客户，与你的D&B代理联系申请公司的邓白氏号。

2.                  Click here for information on how to obtain a free D-U-N-S Number on your own business.

点此为你的公司取得免费邓白氏编号。

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[1] This guidance has been prepared by the Office of the Commissioner (OC), the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), the Center for Veterinary Medicine (CVM), and the Office of Regulatory Affairs (ORA) at the Food and Drug Administration.

紫苏叶

看见一堆英文我头痛，翻译者真是辛苦了