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1、FDA 仿制药费用（GDUFA ）支付（中英文） 以下内容原文 FDA 官网网址：http:/www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/ucm322629.htm Generic Drug User Fee Cover Sheet and Payment Information仿制药费用封面页和支付信息The Generic Drug User Fee Amendments of 2012 authorizes FDA to assess and collect user fees for human generic drug a
2、pplications, certain application supplements, and related manufacturers. Form FDA 3794, also known as the Generic Drug User Fee Cover Sheet or GDUFA Cover Sheet, is designed to collect the minimum necessary information to determine the total applicable user fee required and to help FDA track the use
3、r fee payments. Furthermore, FDAs review of a generic drug submission cannot begin until all relevant user fee obligations have been satisfied.2012 仿制药用户费用修正案赋予了 FDA 权利评估和收取人用仿制药申请、特定的申请增补和相关生产商用户费用。为此 FDA 设计了 3794 表格，即 GDUFA 封面页，用于收集基本信息以决定总的用户费用，并帮助 FDA 跟踪用户费用的支付。另外，FDA 对仿制药申请的审核只有在相关的费用支付后才会开始。AT
4、TENTION 注意FDA issues clarifications for completing the GDUFA Cover Sheet by fee type. Please refer to the appropriate link below to obtain the clarification information. FDA will continue to make updates to these links as it identifies further information that will assist the generic drug industry i
5、n completing cover sheets.FDA 发布的关于填写 GDUFA 封面页的说明是按照费用类型来分的。请参见以下相关链接获得申明信息。为使更多信息能帮助仿制药行业完成封面页，FDA 会继续更新这些链接。Backlog1 (11/16/2012) 积压费Abbreviated New Drug Application (ANDA) (TBD) 简略新药申请Prior Approval Supplement (PAS) (TBD) 预批准变更申请Drug Master File (TBD) 药物主文件Facility (TBD)工厂When is the GDUFA Cover
6、 Sheet required? 什么时候需要 GDUFA 封面页？The GDUFA Cover Sheet is required for each of the following human generic drug user fees:以下人用仿制药用户费用，每个费用均需要一个 GDUFA 封面页：Abbreviated new drug application (ANDA) or applicable amendment; 简略新药申请（ANDA）或增补Prior approval supplement (PAS) or applicable amendment; 预批准变更申请（
7、PAS）或增补FDA 仿制药费用（GDUFA ）支付（中英文） Type II active pharmaceutical ingredient (API) drug master file (DMF) that is referenced on or after October 1, 2012, in a generic drug submission to the FDA and for which the DMF fee has not already been paid; 二类活性药用成分（API）药物主文件（DMF），在 2012 年 10 月 1 日之后（含）被仿制药申请所引用，尚
8、未支付 DMF 费用的Generic drug facility which is identified or intended to be identified in at least one generic drug submission that is pending or approved to produce a finished dosage form (FDF) of a human generic drug or an API contained in a human generic drug; and 仿制药工厂，生产或将要生产至少一种人用仿制药制剂，且尚未获得批准的，或生产
9、原料药用于人用仿制药制剂的，和Backlog ANDA which is pending on October 1, 2012, and that has not received a tentative approval prior to that date.在 2012 年 10 月 1 日因等批准而积压的 ANDA，和在此日期之前未收到临时批准的 ANDANote: A cover sheet is not required for all ANDA and PAS amendments. It is only applicable to an amendment that is add
10、ing API manufacturing information other than by reference to a Type II DMF which is subject to the Section 744B(a)(3)(F) fee under GDUFA.注：并不是所有 ANDA 和 PAS 增补都需要封面页。只有当增补中包括增加原料药生产信息而不是引用二类 DMF，根据 GDUFA 才需要缴纳 744B(a)(3)(F)费用。How to fill out a GDUFA Cover Sheet? 如何填写 GDUFA 封面页？Read the instructions b
11、elow and then go to Create GDUFA Cover Sheet2 to fill out the form.A GDUFA Cover Sheet will be completed online using FDAs User Fee System which requires the use of Microsoft Internet Explorer 7.0 or higher. 先阅读以下指南，然后登录 Create GDUFA Cover Sheet 填写表格，该表格需要使用 FDA 用户费用系统在线填写，需要浏览器为微软 IE7.0 或更高版本。Acces
12、s the User Fee System at Create GDUFA Cover Sheet3. 登录 Create GDUFA Cover Sheet 进入用户费用系统。Register your organization by providing information about your organization. 提供组织机构的信息注册你的组织机构Create a user account for your organization and provide contact information. 为你的组织机构创建一个用户帐号，提供联系信息Create a cover she
13、et by answering a series of questions and making appropriate selections. 依次回答问题，进行适当的选择，创建一个封面页Submit the cover sheet to complete the process and determine the user fee amount owed. Upon submission, a User Fee Payment I.D. Number (PIN), which begins with the letters “GD”, is generated. The PIN must
14、be referenced in your payment submission.提交封面页，完成该过程，确认需要支付的用户费用，会产生一个以“GD”开头的用户费用支付 ID 编号（PIN）。在进行支付时，必须注明此 PIN 编号。Additional instructions for the User Fee System and the process to create a GDUFA Cover Sheet can be located under the Frequently Asked Questions (FAQs)4 within the User Fee System. Fo
15、r FDA 仿制药费用（GDUFA ）支付（中英文） detailed instructions to complete the GDUFA Cover Sheet, please access Form FDA 3794 - Instructions5.关于用户费用系统和创建 GDUFA 封面页的过程更多指南可以在用户费用体系中 Frequently Asked Questions (FAQs)上找到。关于完成 GDUFA 封面页的更多细节指南，参见 Form FDA 3794 - Instructions。Note: A signed copy of a completed GDUFA C
16、over Sheet must be included in the following submissions to the FDA: ANDA or PAS submission (placed in the first volume with Form FDA 356h) and Type II API DMF submission.注：在向 FDA 提交下述申报资料时，必须附入一份已填写完成的 GDUFA 封面页副本：ANDA 或预批准变更申请（放在第一卷，FDA356h 表格中）和二类原料药 DMF 申报。What information is needed to complete a GDUFA Cover Sheet?要完成 GDUFA 封面页，需要哪些信息？General Information一般信息Name/address/contact information of applicant/holder/owner 姓名/地址/申请人、持有人、所有人联系信息Name/address/contact information of
