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Self-Identification of Generic Drug Facilities, Sites, and Organizations 仿制药设施、工厂和组织的自我识别 Guidance for Industry 行业指南 U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) September 2016 Generics
Self-Identification of Generic Drug Facilities, Sites, and Organizations 仿制药设施、工厂和组织自我识别 Guidance for Industry 行业指南 Additional copies are available from: Office of Communications, Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10001 New Hampshire Ave., Hillandale Bldg., 4th Floor Silver Spring, MD 20993-0002 Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353 Email: druginfo@fda.hhs.gov http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm 7519 Standish Place, Rockville, MD 20855 Phone: 240-276-9300 http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) September 2016 Generics
TABLE OF CONTENTS 目录 I. INTRODUCTION | 概述 | II. BACKGROUND | 背景 | III. GDUFA SELF-IDENTIFICATION REQUIREMENTS | GDUFA自我识别要求 | A. Who Is Required to Self-Identify? | 谁要做自我识别？ | B. What Information Is Required for Submission? | 要提交哪些信息？ | 1. D-U-N-S Numbers | 邓白氏号 | 2. Facility Establishment Identifier | 工厂设施识别号 | 3. Additional Information | 其它信息 | C. What Is the Process for Submitting Self-Identification Information? | 提交自我识别信息流程如何？ | D. What Is the Penalty for Failing to Self-Identify? | 不做自我识别有什么处罚？ |
Self-Identification of Generic Drug Facilities, Sites, and Organizations 仿制药设施、工厂和组织的自我识别 Guidance for Industry[1] 行业指南 This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page. 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 概述 This guidance is intended to assist human generic drug facilities, sites, and organizations by describing how to comply with the self-identification requirement contained in the Generic Drug User Fee Amendments of 2012 (Public Law 112-144, Title III), commonly referred to as GDUFA. 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，以协助人用仿制药设施、工厂和组织进行识别。该条款由食品药品管理安全和创新法案（FDASIA）（公共法112-114标题III）修订了关于UFI系统的规定。 Under GDUFA, human generic drug facilities, sites, and organizations are required to submit identification information electronically to FDA annually. FDA is issuing this guidance to help human generic drug facilities, sites, and organizations meet the self-identification requirement. Topics discussed in this guidance include: 根据GDUFA要求，人用仿制药设施、工厂和组织应采用电子方式每年向FDA提交识别信息。FDA签发此指南意在帮助人用仿制药设施、工厂和组织符合自我识别要求。本指南所讨论主题包括： ? which types of generic facilities, sites, and organizations are required to self-identify; ? 什么类型的仿制药设施、工厂和组织需要进行自我识别； ? what information is requested; ? 要提交哪些信息； ? what technical standards are to be used for electronically submitting the requested information; and ? 采用电子方式提交所需信息时要使用什么技术标准；以及 ? the penalty for failing to self-identify. ? 未进行自我识别有什么处罚。 This guidance also explains generally which types of generic facilities, sites, and organizations will be required to pay user fees. 本指南还简单解释了什么类别的仿制药设施、工厂和组织需要支持仿制药用户费。 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 On July 9, 2012, GDUFA was signed into law by the President[2].2 GDUFA is designed to speed the delivery of safe and effective generic drugs to the public and reduce costs to industry. GDUFA enables FDA to assess user fees to support critical and measurable enhancements to FDA’s generic drugs program. GDUFA will also significantly improve global supply chain transparency by requiring owners of facilities producing generic drug products, active pharmaceutical ingredients (API), and certain other sites and organizations that support the manufacture or approval of these products to electronically self-identify with FDA and update that information annually. 在2012年7月，GDUFA由总统签署成为法律。GDUFA设计是为了加快公众获得安全有效仿制药的速度，并减少行业成本。GDUFA使得FDA可以评估用户费用，以可以度量的方式强化关键的FDA仿制药程序。通过要求生产仿制药、原料药的场所，以及其它特定的场所和支持生产或批准这些药品的组织以电子方式向FDA进行自我识别，并每年更新信息，GDUFA也会大大改善全球供应链的透明度。 Self-identification is required for two purposes. First, it is necessary to determine the universe of facilities required to pay user fees. Second, self-identification is a central component of an effort to promote global supply chain transparency. The information provided through self-identification enables quick, accurate, and reliable surveillance of generic drugs and facilitates inspections and compliance. 要求进行自我识别有2个目的。首先，是为了确定需要支付用户费用的场所数量。其次，自我识别是提高全球供应链透明度的一个核心组成部分。通过自我识别所提供的信息，药监当局可以快速、准确可靠地对仿制药品进行监管，促进检查和符合性。 Most facilities that self-identify are required to pay an annual facility user fee. These include facilities manufacturing, or intending to manufacture, API of human generic drugs and/or finished dosage form (FDF) human generic drugs. Other sites and organizations must self-identify, but are not required to pay the annual facility user fee. These include facilities that solely manufacture positron emission tomography (PET) drugs, or sites and organizations that only perform testing, repackaging, or relabeling operations. Please note that while repackagers are not required to pay user fees, packagers are, in most cases, FDF manufacturers and subject to facility fees. 大多数需要进行自我识别的场所都需要支持年度工厂用户费。其中包括生产和有单身生产人用仿制的原料药（API）和/或人用仿制药制剂（FDF）。其它场所和组织必须进行自我识别，但不要求支持年度工厂费用。其中包括仅生产正电子发射计算机断层显像（PET）药物的工厂，或仅进行检验、重新包装或重新标签操作的工厂和组织。请注意，尽管重新包装商不要求支持用户费用，但是包装商在大多数情形下是FDF生产商，并且需要支持工厂费用。 A separate system for the electronic self-identification of generic industry facilities, sites, and organizations was established for GDUFA. Entities required to register and list (under section 510 of the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act), and those required to self-identify under GDUFA submit information separately to the respective systems. Each system populates its own database to meet unique requirements and deadlines. The separate GDUFA system uses the same platform and technical standards already familiar to manufacturers required to register and list. 仿制药行业设施、工厂和组织的电子自我识别所用独立系统是为GDUFA建立的。各实体组织应注册并列入清单（根据FDCA第510部分或PHSA第351部分），依据GDUFA需要进行自我识别的则应单独提交信息至相关系统。每个系统均有自己的数据库，以符合唯一要求和时间期限。单独的GDUFA系统使用的是进行注册和列清单的生产商所熟悉的相同平台和技术标准。 III. GDUFA SELF-IDENTIFICATION REQUIREMENTS GDUFA自我识别要求 The following discussion explains who is required to self-identify, what information is required for submission, and what the process is for submitting self-identification information. 以下讨论解释了谁要进行自我识别，需要提交哪些信息，以及提交自我识别信息的过程如何。 A. Who Is Required to Self-Identify? 谁需要进行自我识别？ The following types of generic industry facilities, sites, and organizations are required to self-identify with FDA: 以下类型的仿制药行业设施、工厂和组织需要向FDA进行自我识别： 1. Facilities[3] that manufacture, or intend to manufacture, human generic drug APIs or FDFs, or both[4].
生产或有意生产人用仿制药API或FDF或都生产的场所。 2. Facilities that package the FDF of a human generic drug into the primary container/closure system and label the primary container/closure system[5]
包装人用仿制药FDF至内包装容器/密闭系统并对内包装容器/容器系统进行标签的场所。 3. Sites that are identified in a generic drug submission and pursuant to a contract with the applicant remove the drug from a primary container/closure system and subdivide the contents into a different primary container/closure system.
在仿制药申报中识别的工厂，作为申报者的合同生产场所，将药品从内包装容器/密闭系统取出，分装至不同的内包装容器/密闭系统。 4. Bioequivalence (BE)/bioavailability (BA) sites that are identified in a generic drug submission and conduct clinical BE/BA testing, bioanalytical testing of samples collected from clinical BE/BA testing, and/or in vitro BE testing.
在仿制药申报中识别为生物等效性（BE）/生物利用度（BA）的场所，以及实施临床BE/BA测试、从临床BE/BA测试中收集样品进行生物分析测试，和/或体外BE测试的场所。 5. Sites that are identified in a generic drug submission and perform testing of one or more attributes or characteristics of the FDF or the API pursuant to a contract with the applicant to satisfy a current good manufacturing practice (CGMP) testing requirement (excludes sites that are testing for research purposes only).
在仿制药申报中识别进行一个或多个FDF或API性质或结构测试，有意成为申报者的合同商满足CGMP检测要求的工厂（仅以研发为目的进行的测试除外）。 B. What Information Is Required for Submission? 要提交什么信息？ The following information is required to meet the self-identification requirement in GDUFA: 符合GDUFA里自我识别要求需要提交以下信息： 1. D-U-N-S Numbers 邓白氏号 FDA requires Data Universal Numbering System (D-U-N-S) numbers for both the facility or site and the registrant owner of the facility or site if the facility or site is in a different location than the registrant owner location. A D-U-N-S number is required to uniquely identify the registrant (the owner or operator) and each physical location of the business’s facility or site (e.g., branches, divisions, and headquarters). 如果注册所有者的地址和场所或工厂地址不同，则两者均要提交邓白氏号。每个注册者（所有者或运营者）和商业场所或工厂的每个物理地址（例如，分支机构、分部和总部）均要有一个邓白氏号来唯一识别。 A D-U-N-S number is a unique nine-digit sequence provided by Dun & Bradstreet. The D-U-N-S number is specific for each site. Each distinct physical location of an entity (e.g., branch, division, and headquarter) would be assigned a different D-U-N-S number. 邓白氏号是由邓白氏所提供的一个唯一的9位数字序列。每个工厂的邓白氏号是特别的。一个实体的不同物理地址（例如，分支机构、分部和总部）会获得一个不同的邓白氏号。 The site-specific D-U-N-S number is a widely recognized business identification tool and serves as a useful resource for FDA in identifying and verifying certain business information submitted by a user. 工厂唯一的邓白氏号是一个被广泛认可的商业识别工具，是FDA在识别和核查用户所提交的特定业务信息时有用的资源。 If no D-U-N-S number has been assigned, a business entity may obtain one at no cost directly from Dun & Bradstreet. A new number may be obtained, or an existing number verified, by phone or online. Existing facilities D-U-N-S numbers may also be verified on FDA’s currentregistration site for drug establishments[6] 如果商业实体还没有获得邓白氏号，可以直接从邓白氏获得一个免费的号。可以通过电话或在线方式获取新号，或核查已有编号。已有的场所邓白氏号也可以在FDA的药品设施注册工厂中进行验证。 Note: It takes Dun & Bradstreet approximately 30 business days to process a new D-U-N-S number and communicate it via email. A business entity may receive a D-U-N-S number in approximately 10 business days for an expedited service fee. Please note that a business entity may not request or apply for a new D-U-N-S number on behalf of another business entity due to the verification procedures used by Dun & Bradstreet. 注：邓白氏需要30个工作日来处理新的邓白氏号，并通过邮件沟通。商业实体可以通过付费服务在10个工作日内获得编号。请注意，由于邓白氏所用的核查程序，商业实体不可以以另一商业实体的名义要求或申请新的邓白氏号。 More information is available at the Dun & Bradstreet web page. See also the step-by-step instructions for obtaining a D-U-N-S number for businesses based either in the United States or abroad. 更多信息可以在邓白氏官网上找到。也可以参见上述网站“手把手教你申请邓白氏编号”。 2. Facility Establishment Identifier 设施识别号 Facilities must also submit a Facility Establishment Identifier (FEI), a unique identifier designated by FDA to assign, monitor, and track inspections of regulated firms[7]. 工厂还必须提交设施识别号（FIE），由FDA给定的一个唯一识别号，用于指定、监测和跟踪受法规约束的公司的检查。 A business entity that has previously obtained an FEI number may verify its FEI number by sending an email request toFDAGDUFAFEIRequest@fda.hhs.gov. 一个之前已经有了FEI号的商业实体可以通过发送邮件至上述邮箱验证其FEI号。 Alternatively, business entities that have not previously registered with FDA can obtain an FEI number by sending an email request toFDAGDUFAFEIRequest@fda.hhs.gov. Please type “GDUFA FEI Request” in the subject line and include the following information in the body of the email: 而如果之前没有在FDA登记，可以发送邮件至上述邮箱获得一个FEI号。邮件主题请标明“GDUFA FEI Request”，邮件正言语应包括以下信息： ? Firm Name 公司名称 ? Facility Address including City, Province, Country, and Mail Code 工厂地址，包括城市、省份、国家和邮编号 ? Size of Firm 公司规模 ? Type of Operation (Manufacturer, Lab, etc.) 操作类型（生产商、实验室等） ? Type of Industry: Drugs 行业类型：药品 Requests for issuance of FEI numbers associated with GDUFA self-identification are typically processed within 10 to 15 business days. 与GDUFA自我识别一起的FEI号签发申请一般会需要10-15个工作日。 3. Additional Information 其它信息 FDA requests the name and contact information for the registrant owner and facility information, including name, type of business operation, and contact information. Submitters are also asked to indicate whether they manufacture drugs that are not generic drugs. FDA要求注册者所有人的名称和联系方式以及工厂信息，包括名称、所运营的业务类型以及联系方式。提交者还应说明是否是非仿制药的药品生产商。 C. What Is the Process for Submitting Self-Identification Information? 如何提交自我识别信息？ The self-identification process is similar to other FDA electronic submission standards. Self-identification files should be formatted in the same electronic messaging standard used for drug registration and listing information and for the content of labeling for abbreviated new drug applications (ANDAs). This standard, known as Health Level Seven Structured Product Labeling (SPL), allows information to be exchanged, searched, and combined with other data sources in a manner that supports health information technology initiatives to improve patient care. 自我识别过程与其它FDA电子申报标准类似。自我识别文件的格式与药品注册和列表信息所用的电子信息标准所用格式，以及ANDA标签内容提交所用格式相同。此标准被称为SPL标准，使其可以进行信息交换、搜索及与其它数据源的合并，支持卫生信息技术改善患者保护的倡议。 Providing Regulatory Submissions in Electronic Format — Drug Establishment Registration and Drug Listing[8] provides detailed instructions on how to submit information using SPL. FDA also offers tools and information for creating and submitting SPL files. Additional information can be found at www.fda.gov/edrls “采用电子格式提供法规申报资料---药物设施登记和药品列表”提供了如何使用SPL提交信息的详细指导。FDA还提供了创建和提交SPL文件的工具和信息。更多信息可以在上述网址找到。 D. What Is the Penalty for Failing to Self-Identify? 未进行自我识别有什么处罚？ Although GDUFA provides no explicit penalty for sites and organizations that fail to comply with the self-identification requirement, the failure of a site or organization to comply with the law and self-identify may raise significant concerns about that site. Such failure is a factor that may increase the likelihood of a site inspection prior to approval. FDA does not expect to give priority to completion of inspections that are required simply because sites fail to comply with self-identification requirements. 尽管GDUFA对于不满足自我识别要求的工厂和组织并没有明确的处罚说明，但工厂或组织不符合法律和自我识别可能会引起对工厂的担心。工厂发生此类问题会增加批准前检查的可能性。FDA并不希望仅是因为工厂没有符合自我识别要求而将其检查进行优先安排。 More importantly, under GDUFA, if a facility fails to self-identify, all FDF or API products manufactured at the facility and all FDFs containing APIs manufactured at the facility will be deemed misbranded.9 It is a violation of federal law to ship misbranded products in interstate commerce or to import them into the United States. Such violations can result in prosecution of those responsible, injunctions, or seizures of the misbranded products. Products that are deemed misbranded because of failure of the facility to self-identify are subject to being denied entry into the United States. 更为重要的是，根据GDUFA要求，如果一个工厂未能进行自我识别，该场所生产的所有FDF或API产品，以及含有该场所生产的API的所有FDF将会被作为冒牌产品。将冒牌药品在州际间进行贸易或将冒牌药品出口至美国是违反联邦法律的。此类违法行为将导致对责任人进行起诉、发布强制令或扣押冒牌药品。由于工厂未进行自我识别而被认为是冒牌药品的将被拒绝进入美国。
FDA Tracking #: 14819 FRDTS # 2013-90 Drafted: ALeboeuf/OGD 11/2/2015 Reviewed: DNaik/CDER/OPQ/OS/DQIRAM/DIB 11/3/2015 PLoebach/ CDER/OC/OPRO/DRLS 11/4/2015 Reviewed: SLevine/OGD 03/28/16 Revised: HSchwirck/OGD 04/12/16 Reviewed: MNguyen/OGD 04/13/16 Cleared: DBeers/OCC 09/2/16 Final: ALeBoeuf/OGDP 09/09/16
[1] This guidance has been prepared by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration. 本指南由CDER和CBER起草。
[2] On October 5, 2012 the President signed into law the FDA User Fee Correction Act of 2012. This act amends GDUFA so that due dates for GDUFA user fees in fiscal year 2013 are not dependent on enactment of an appropriations act. 在2012年10月5日，总统签署了FDA用户费用2012修正案。该法案对GDUFA做了修订，这样GDUFA用户费用在2013财年的缴费期限不再是依据拨款法规的实施。
[3] GDUFA has defined the term “facility” to identify those businesses required to pay fees and for self-identification. GDUFA defines a facility as a business or other entity under one management, either direct or indirect, at one geographic location or address, engaged in manufacturing or processing an API or an FDF. It does not include a business or other entity whose only manufacturing or processing activities are one or more of the following: repackaging, relabeling, or testing. Separate buildings within close proximity are considered to be at one geographic location or address if the activities in them are closely related to the same business enterprise; are under the supervision of the same local management; and are capable of being inspected by FDA during a single inspection. GDUFA further states that if a business entity would meet the definition of a facility but for being under multiple management, the business or entity is deemed to constitute multiple facilities, one per management entity. GDUFA对术语“场所”给出了定义，以识别那些需要支付费用和进行自我识别的业务。GDUFA定义场所为从事API或FDF生产或加工，受到直接或间接管理，位于一个地理位置或地址的一个业务或其它实体。它不包括仅从事以下一个或多个生产或加工活动的业务或其它实体：重新包装、重新标签或检测。如果其活动与相同的业务实体均紧密相关，受到相同的当地管理方的监管，FDA可以在同一次检查中进行检查，则在很近距离内的不同建筑物认为是同一个地理位置或地址。GDUFA进一步声明说如果一个业务实体符合场所的定义，但受到多方管理，则该业务或实体就是多个场所，每一个管理实体是一个场所。
[4] For purposes of self-identification and payment of fees, GDUFA defines API and FDF manufacturers differently from the way these categories of manufacturers have been defined historically. For example, generic drug manufacturers who mix an API when the substance is unstable or cannot be transported on its own are considered API manufacturers and not FDF manufacturers for self-identification and the payment of GDUFA fees only. 在自我识别和费用支付中，GDUFA对API和FDF生产商的定义不同于黑历史上对生产商分类的方式。例如，当API不稳定或者无法单独运输而对API进行混合的仿制药生产商被认为是API生产商，而不需自我识别为FDF生产商，也不需要支持GDUFA费用。 GDUFA defines an FDF as: GDUFA将FDF定义为 (A) a drug product in the form in which it will be administered to a patient, such as a tablet, capsule, solution, or topical application; 患者会摄入的药品形式，例如片剂、胶囊、溶液或局部使用； (B) a drug product in a form in which reconstitution is necessary prior to administration to a patient, such as oral suspensions or lyophilized powders; or 在患者摄入之前需要重新组合的药品，例如口服混悬液或冻干粉；或 (C) any combination of an active pharmaceutical ingredient (as defined in the statute) with another component of a drug product for purposes of production of a drug product described in subparagraph (A) or (B). API与另一药物成分为了上述（A）或（B）中所述药品生产为目的的组合物。 GDUFA defines an API as: GDUFA定义API为 (A) a substance, or a mixture when the substance is unstable or cannot be transported on its own, intended— 一种物质，或当该物质不稳定或无法单独运输时进行混合后的混合物，用于： (i) to be used as a component of a drug; and 用作一种药物的成分，以及 (ii) to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the human body; or 用于修饰药性活动或在诊断、治愈、缓解、治疗或防治疾病时起到直接作用，或者对人体结构或功能有影响；或 (B) a substance intended for final crystallization, purification, or salt formation, or any combination of those activities, to become a substance or mixture described in subparagraph (A). 用于最终结晶、精制或成盐，或其它多个活动，成为上述（A）段中所述的物质或混合物的物质。
[5] Facilities that package the FDF of a human generic drug into the primary container/closure system and label the primary container/closure system are considered to be manufacturers, whether or not that packaging is done pursuant to a contract or by the applicant itself. 包装人用仿制药FDF至内包装容器/密闭系统，并对内包装容器/密闭系统进行标签的场所，不管该包装是否由申报者自己做还是作为合同商来做，均被认为是生产商。
[7] For the Agency’s policy on the assignment of FEIs, please refer to Field Management Directive (FMD) #130, Official Establishment Inventory (OEI) Development and Maintenance, which provides standardized definitions and associated procedures to facilitate consistency of data in the OEI. 关于FEI号给定程序，请参见现场管理指令（FMD）第130号“官方设施清单（OEI）建立和维护”，其中给出了标准化定义和相关程序，促进了OEI数据中一致性。
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