FDA仿制药费用(GDUFA)支付(中英文)

1、以下内容原文FDA官网网址：http：/wwwfdagov/Forlndustry/UserFees/GenericDrugUserFees/ucm322629htmGenericDrugUserFeeCoverSheetandPaymentInformation仿制药费用封面页和支付信息TheGenericDrugUserFeeAmendmentsof2012authorizesFDAtoassessandcollectuserfeesforhumangenericdrugapplications,certainapplicationsupplements,andrelatedmanufac

2、turers.FormFDA3794,alsoknownastheGenericDrugUserFeeCoverSheetorGDUFACoverSheet,isdesignedtocollecttheminimumnecessaryinformationtodeterminethetotalapplicableuserfeerequiredandtohelpFDAtracktheuserfeepayments.Furthermore,FDAsreviewofagenericdrugsubmissioncannotbeginuntilallrelevantuserfeeobligationsh

3、avebeensatisfied.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FDAissuesclarificationsforcompletingtheGDUFACoverSheetbyfeetype.Pleaserefertotheappropriatelinkbelowtoobtaintheclarificationinfor

4、mation.FDAwillcontinuetomakeupdatestotheselinksasitidentifiesfurtherinformationthatwillassistthegenericdrugindustryincompletingcoversheets.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AbbreviatedNewDrugApplication(ANDA)(TBD)简略新药申请PriorApprov

5、alSupplement(PAS)(TBD)预批准变更申请DrugMasterFile(TBD)药物主文件Facility(TBD)工厂WhenistheGDUFACoverSheetrequired?什么时候需要GDUFA封面页？TheGDUFACoverSheetisrequiredforeachofthefollowinghumangenericdruguserfees:以下人用仿制药用户费用，每个费用均需要一个GDUFA封面页：Abbreviatednewdrugapplication(ANDA)orapplicableamendment;简略新药申请(ANDA)或增补Priorapp

6、rovalsupplement(PAS)orapplicableamendment;预批准变更申请(PAS)或增补TypeIIactivepharmaceuticalingredient(API)drugmasterfile(DMF)thatisreferencedonorafterOctober1,2012,inagenericdrugsubmissiontotheFDAandforwhichtheDMFfeehasnotalreadybeenpaid;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，尚未支付DMF费用的Genericdru

7、gfacilitywhichisidentifiedorintendedtobeidentifiedinatleastonegenericdrugsubmissionthatispendingorapprovedtoproduceafinisheddosageform(FDF)ofahumangenericdrugoranAPIcontainedinahumangenericdrug;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，或生产原料药用于人用仿制药制剂的，和BacklogANDAwhichispendingonOctober1,2012,andthathas

8、notreceivedatentativeapprovalpriortothatdate.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:AcoversheetisnotrequiredforallANDAandPASamendments.ItisonlyapplicabletoanamendmentthatisaddingAPImanufacturinginformationotherthanbyreferencetoaTypeIIDMFwhichissubjecttotheSection744B(a)(3)(F)feeunderGDUFA.注

9、：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。HowtofilloutaGDUFACoverSheet?如何填写GDUFA封面页？ReadtheinstructionsbelowandthengotoCreateGDUFACoverSheet2tofillouttheform.AGDUFACoverSheetwillbecompletedonlineusingFDAsUserFeeSystemwhichrequirestheuseofMicrosoftInternetExplorer

10、7.0orhigher.先阅读以下指南，然后登录CreateGDUFACoverSheet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。AccesstheUserFeeSystematCreateGDUFACoverSheet3.登录CreateGDUFACoverSheet进入用户费用系统。Registeryourorganizationbyprovidinginformationaboutyourorganization.提供组织机构的信息注册你的组织机构Createauseraccountforyourorganizationandprovid

11、econtactinformation.为你的组织机构创建一个用户帐号，提供联系信息Createacoversheetbyansweringaseriesofquestionsandmakingappropriateselections.依次回答问题，进行适当的选择，创建一个封面页Submitthecoversheettocompletetheprocessanddeterminetheuserfeeamountowed.Uponsubmission,aUserFeePaymentI.D.Number(PIN),whichbeginswiththeletters“GD”,isgenerated

12、.ThePINmustbereferencedinyourpaymentsubmission.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。AdditionalinstructionsfortheUserFeeSystemandtheprocesstocreateaGDUFACoverSheetcanbelocatedundertheFrequentlyAskedQuestions(FAQs)4withintheUserFeeSystem.Fordetailedinstructionstocompl

13、etetheGDUFACoverSheet,pleaseaccessFormFDA3794-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FrequentlyAskedQuestions(FAQs)上找至U。关于完成GDUFA圭寸面页的更多细节指南，参见FormFDA3794-InstructionsNote:AsignedcopyofacompletedGDUFACoverSheetmustbeincludedinthefollowingsubmissionstotheFDA:ANDAorPASsubmission(placedinthe

14、firstvolumewithFormFDA356h)andTypeIIAPIDMFsubmission.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。WhatinformationisneededtocompleteaGDUFACoverSheet?要完成GDUFA封面页，需要哪些信息？GeneralInformation一般信息Name/address/contactinformationofapplicant/holder/owner姓名/地址/申请人、持有人、所有人联系

15、信息Name/address/contactinformationofrepresentative/U.S.agent姓名/地址/代表人、美国代理联系信息ANDA/PAS简略新药申请/预批准变更申请ANDAapplicationnumberassignedbyFDA由FDA给定的ANDA申请编号Establishednameofproduct产品名称Ifapplicable,forSection744B(a)(3)(F)*only如果适用时，仅针对744B(a)(3)(F)(见注)类别Nameofdrugsubstance(s)/API(s)药用物质/原料药名称Allfacilitiesinc

16、ludingfacilitysname,address,FEInumber,facilityDUNSnumber,andtheuserfeepaymentIDnumber(ifSection744B(a)(3)(F)feehasalreadybeenpaid)所有工厂，包括工厂名称、地址、FEI号、工厂邓氏号，用户费用支付ID编号(如果744B(a)(3)(F)费用已支付)GDUFArequiresapplicantstopaytheSection744B(a)(3)(F)feeiftheapplicationincludesAPImanufacturinginformationotherth

17、anbyreferencetoaTypeIIDMF.GDUFA要求在申请中包括原料药生产信息，而非引用二类DMF的申请人支付744B(a)(3)(F)费用。TypeIIAPIDMF二类原料药DMFDMFnumberassignedbyFDA由FDA给定的DMF编号Drugsubstance/APIname药用物质/原料药名称Facility工厂Facilitysname,address,FEInumber,andfacilityDUNSnumber工厂名称、地址、FEI号、工厂邓白氏号Confirmationwhetherthefacilitymanufactureshumandrugstha

18、tarenothumangenericdrugs确认工厂是生产人用药，而非人用仿制药Backlog积压费ANDAapplicationnumberassignedbyFDAFDA给定的ANDA申请编号Establishednameofproduct产品名称Howarepaymentssubmitted?如何支付费用？ApaymentmaybesubmittedbyP(electronicpayment),check,bankdraft,U.S.postalmoneyorder,orwiretransfer.Forallpaymentoptions,thepaymentmustbemadeinU

19、.S.currencydrawnonaU.S.financialinstitution.FDArecommendsthatuserfeepaymentsbemadeinatimelymannertomeettherequiredpaymentduedateortobereceivedpriortoanapplicationsubmission.Forapplicationsubmissions,itisrecommendedthatyousendmanualpaymentstothebank4-5businessdaysbeforetheapplicationsubmissionarrives

20、atFDAsothatthereisnodelayinstartingthereviewofyourapplicationsubmission.Pleasefollowtheinstructionsbelowforyourselectedpaymentoption:费用可以通过P(电子支付)、支票、银行汇票、美国邮政汇票或电汇方式支付。所有支付方式均应以美元形式存入一家美国金融机构。FDA建议及时支付用户费用，以免超期，或者保证在申请提交前收到付款。提交申报资料时，建议你在申报资料到达FDA之前4-5天进行人工支付，以保证不会延迟对申报的审核。请根据下列指示选择付费方式：PaymentOpti

21、ons付费方式Instructions付费步骤P网上在线支付Pisaweb-basedpaymentapplicationthatallowselectronicpaymentstobemadedirectlyfromyourbankaccount.ApaymentcanbeinitiatedaftersubmittingyourcoversheetbyclickingthePayNowbuttonandfollowingtheon-screeninstructionstomakepayment.Topaylater,logintoyourGDUFAUserFeeaccountandacces

22、syourcoversheethistorypagebyclickingonthePreviousCoverSheetsiconatthetopofthepage.ClickthePayNowlinknexttotheUserFeePaymentI.D.Number(PIN)youneedtopayfor.P是一个在线支付工具，可以直接从你的帐号进行电子支付。在提交封面页后，点击“PayNow”按钮，根据屏幕上的提示进行支付。如果要稍后支付，则登录你的GDUFA用户帐号，点击页面顶端PreviousCoverSheets进入原来的封面页，点击你所需要支付的用户费用支付ID编号（PIN）旁的“P

23、ayNow”链接。PaymentmustbemadepayabletotheFoodandDrugAdministrationandmakereferencetotheUserFeePaymentI.D.Number(PIN).Thepaymentandacopyofyoursignedcoversheetmustbemailedtooneoftheaddressesshownbelow.费用必须付至FDA,并可以索引至用户费用支付ID号(PIN)。费用与签字后的封面页副本必须邮至以下地址之一。Check,BankDraft,orU.S.PostalMoneyOrder支票、银行汇票或美国邮政

24、汇款Paymentsbymail邮件支付FoodandDrugAdministrationP.O.Box979108St.Louis,MO63197-9000Paymentsbycourier快递支付U.S.BankAttention:GovernmentLockbox9791081005ConventionPlazaSt.Louis,MO63101Note:ContacttheU.S.Bankat(314)418-4013ifyouhaveanyquestionsconcerningdeliverybycourier.Contactyourfinancialinstitutionandpro

25、videthefollowinginformation:WireTransfer电汇BankName|TelegraphicName:银行名称|电信公司名称U.S.DepartmentofTreasury|TREASNYCBankAddress:银行地址33LibertyStreet|NewYork,NY10045AccountNumber:帐号75060099RoutingNumber:路由号码021030004SWIFTNumber:FRNYUS33请与你们的金融机构联系，并给他们提供以下信息SWIFT代码Beneficiary:FDA|1350PiccardDrive,Suite200A|Rockville,收款人MD20850Description:Referencet