FDA仿制药费(GDUFA)支付(中英文).docVIP

以下内容原文FDA官网网址：/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 applications, 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 user fee payments. Furthermore, FDA’s 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。 ATTENTION 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 in 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 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（PAS）或增补 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）