FDA仿制藥費(fèi)用(GDUFA)支付(中英文)

1、以下內(nèi)容原文FDA官網(wǎng)網(wǎng)址：http：/wwwfdagov/Forlndustry/UserFees/GenericDrugUserFees/ucm322629htmGenericDrugUserFeeCoverSheetandPaymentInformation仿制藥費(fèi)用封面頁(yè)和支付信息TheGenericDrugUserFeeAmendmentsof2012authorizesFDAtoassessandcollectuserfeesforhumangenericdrugapplications,certainapplicationsupplements,andrelatedmanufac

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

3、avebeensatisfied.2012仿制藥用戶費(fèi)用修正案賦予了FDA權(quán)利評(píng)估和收取人用仿制藥申請(qǐng)、特定的申請(qǐng)?jiān)鲅a(bǔ)和相關(guān)生產(chǎn)商用戶費(fèi)用。為此FDA設(shè)計(jì)了3794表格，即GDUFA封面頁(yè)，用于收集基本信息以決定總的用戶費(fèi)用，并幫助FDA跟蹤用戶費(fèi)用的支付。另外，F(xiàn)DA對(duì)仿制藥申請(qǐng)的審核只有在相關(guān)的費(fèi)用支付后才會(huì)開(kāi)始。ATTENTION注意FDAissuesclarificationsforcompletingtheGDUFACoverSheetbyfeetype.Pleaserefertotheappropriatelinkbelowtoobtaintheclarificationinfor

4、mation.FDAwillcontinuetomakeupdatestotheselinksasitidentifiesfurtherinformationthatwillassistthegenericdrugindustryincompletingcoversheets.FDA發(fā)布的關(guān)于填寫(xiě)GDUFA封面頁(yè)的說(shuō)明是按照費(fèi)用類(lèi)型來(lái)分的。請(qǐng)參見(jiàn)以下相關(guān)鏈接獲得申明信息。為使更多信息能幫助仿制藥行業(yè)完成封面頁(yè)，F(xiàn)DA會(huì)繼續(xù)更新這些鏈接。Backlog1(11/16/2012)積壓費(fèi)AbbreviatedNewDrugApplication(ANDA)(TBD)簡(jiǎn)略新藥申請(qǐng)PriorApprov

5、alSupplement(PAS)(TBD)預(yù)批準(zhǔn)變更申請(qǐng)DrugMasterFile(TBD)藥物主文件Facility(TBD)工廠WhenistheGDUFACoverSheetrequired?什么時(shí)候需要GDUFA封面頁(yè)？TheGDUFACoverSheetisrequiredforeachofthefollowinghumangenericdruguserfees:以下人用仿制藥用戶費(fèi)用，每個(gè)費(fèi)用均需要一個(gè)GDUFA封面頁(yè)：Abbreviatednewdrugapplication(ANDA)orapplicableamendment;簡(jiǎn)略新藥申請(qǐng)(ANDA)或增補(bǔ)Priorapp

6、rovalsupplement(PAS)orapplicableamendment;預(yù)批準(zhǔn)變更申請(qǐng)(PAS)或增補(bǔ)TypeIIactivepharmaceuticalingredient(API)drugmasterfile(DMF)thatisreferencedonorafterOctober1,2012,inagenericdrugsubmissiontotheFDAandforwhichtheDMFfeehasnotalreadybeenpaid;二類(lèi)活性藥用成分(API)藥物主文件(DMF)，在2012年10月1日之后(含)被仿制藥申請(qǐng)所引用，尚未支付DMF費(fèi)用的Genericdru

7、gfacilitywhichisidentifiedorintendedtobeidentifiedinatleastonegenericdrugsubmissionthatispendingorapprovedtoproduceafinisheddosageform(FDF)ofahumangenericdrugoranAPIcontainedinahumangenericdrug;and仿制藥工廠，生產(chǎn)或?qū)⒁a(chǎn)至少一種人用仿制藥制劑，且尚未獲得批準(zhǔn)的，或生產(chǎn)原料藥用于人用仿制藥制劑的，和BacklogANDAwhichispendingonOctober1,2012,andthathas

8、notreceivedatentativeapprovalpriortothatdate.在2012年10月1日因等批準(zhǔn)而積壓的ANDA，和在此日期之前未收到臨時(shí)批準(zhǔn)的ANDANote:AcoversheetisnotrequiredforallANDAandPASamendments.ItisonlyapplicabletoanamendmentthatisaddingAPImanufacturinginformationotherthanbyreferencetoaTypeIIDMFwhichissubjecttotheSection744B(a)(3)(F)feeunderGDUFA.注

9、：并不是所有ANDA和PAS增補(bǔ)都需要封面頁(yè)。只有當(dāng)增補(bǔ)中包括增加原料藥生產(chǎn)信息而不是引用二類(lèi)DMF，根據(jù)GDUFA才需要繳納744B(a)(3)(F)費(fèi)用。HowtofilloutaGDUFACoverSheet?如何填寫(xiě)GDUFA封面頁(yè)？ReadtheinstructionsbelowandthengotoCreateGDUFACoverSheet2tofillouttheform.AGDUFACoverSheetwillbecompletedonlineusingFDAsUserFeeSystemwhichrequirestheuseofMicrosoftInternetExplorer

10、7.0orhigher.先閱讀以下指南，然后登錄CreateGDUFACoverSheet填寫(xiě)表格，該表格需要使用FDA用戶費(fèi)用系統(tǒng)在線填寫(xiě)，需要瀏覽器為微軟IE7.0或更高版本。AccesstheUserFeeSystematCreateGDUFACoverSheet3.登錄CreateGDUFACoverSheet進(jìn)入用戶費(fèi)用系統(tǒng)。Registeryourorganizationbyprovidinginformationaboutyourorganization.提供組織機(jī)構(gòu)的信息注冊(cè)你的組織機(jī)構(gòu)Createauseraccountforyourorganizationandprovid

11、econtactinformation.為你的組織機(jī)構(gòu)創(chuàng)建一個(gè)用戶帳號(hào)，提供聯(lián)系信息Createacoversheetbyansweringaseriesofquestionsandmakingappropriateselections.依次回答問(wèn)題，進(jìn)行適當(dāng)?shù)倪x擇，創(chuàng)建一個(gè)封面頁(yè)Submitthecoversheettocompletetheprocessanddeterminetheuserfeeamountowed.Uponsubmission,aUserFeePaymentI.D.Number(PIN),whichbeginswiththeletters“GD”,isgenerated

12、.ThePINmustbereferencedinyourpaymentsubmission.提交封面頁(yè)，完成該過(guò)程，確認(rèn)需要支付的用戶費(fèi)用，會(huì)產(chǎn)生一個(gè)以“GD”開(kāi)頭的用戶費(fèi)用支付ID編號(hào)(PIN)。在進(jìn)行支付時(shí)，必須注明此PIN編號(hào)。AdditionalinstructionsfortheUserFeeSystemandtheprocesstocreateaGDUFACoverSheetcanbelocatedundertheFrequentlyAskedQuestions(FAQs)4withintheUserFeeSystem.Fordetailedinstructionstocompl

13、etetheGDUFACoverSheet,pleaseaccessFormFDA3794-Instructions5.關(guān)于用戶費(fèi)用系統(tǒng)和創(chuàng)建GDUFA封面頁(yè)的過(guò)程更多指南可以在用戶費(fèi)用體系中FrequentlyAskedQuestions(FAQs)上找至U。關(guān)于完成GDUFA圭寸面頁(yè)的更多細(xì)節(jié)指南，參見(jiàn)FormFDA3794-InstructionsNote:AsignedcopyofacompletedGDUFACoverSheetmustbeincludedinthefollowingsubmissionstotheFDA:ANDAorPASsubmission(placedinthe

14、firstvolumewithFormFDA356h)andTypeIIAPIDMFsubmission.注：在向FDA提交下述申報(bào)資料時(shí)，必須附入一份已填寫(xiě)完成的GDUFA封面頁(yè)副本：ANDA或預(yù)批準(zhǔn)變更申請(qǐng)(放在第一卷，F(xiàn)DA356h表格中)和二類(lèi)原料藥DMF申報(bào)。WhatinformationisneededtocompleteaGDUFACoverSheet?要完成GDUFA封面頁(yè)，需要哪些信息？GeneralInformation一般信息Name/address/contactinformationofapplicant/holder/owner姓名/地址/申請(qǐng)人、持有人、所有人聯(lián)系

15、信息Name/address/contactinformationofrepresentative/U.S.agent姓名/地址/代表人、美國(guó)代理聯(lián)系信息ANDA/PAS簡(jiǎn)略新藥申請(qǐng)/預(yù)批準(zhǔn)變更申請(qǐng)ANDAapplicationnumberassignedbyFDA由FDA給定的ANDA申請(qǐng)編號(hào)Establishednameofproduct產(chǎn)品名稱(chēng)Ifapplicable,forSection744B(a)(3)(F)*only如果適用時(shí)，僅針對(duì)744B(a)(3)(F)(見(jiàn)注)類(lèi)別Nameofdrugsubstance(s)/API(s)藥用物質(zhì)/原料藥名稱(chēng)Allfacilitiesinc

16、ludingfacilitysname,address,FEInumber,facilityDUNSnumber,andtheuserfeepaymentIDnumber(ifSection744B(a)(3)(F)feehasalreadybeenpaid)所有工廠，包括工廠名稱(chēng)、地址、FEI號(hào)、工廠鄧氏號(hào)，用戶費(fèi)用支付ID編號(hào)(如果744B(a)(3)(F)費(fèi)用已支付)GDUFArequiresapplicantstopaytheSection744B(a)(3)(F)feeiftheapplicationincludesAPImanufacturinginformationotherth

17、anbyreferencetoaTypeIIDMF.GDUFA要求在申請(qǐng)中包括原料藥生產(chǎn)信息，而非引用二類(lèi)DMF的申請(qǐng)人支付744B(a)(3)(F)費(fèi)用。TypeIIAPIDMF二類(lèi)原料藥DMFDMFnumberassignedbyFDA由FDA給定的DMF編號(hào)Drugsubstance/APIname藥用物質(zhì)/原料藥名稱(chēng)Facility工廠Facilitysname,address,FEInumber,andfacilityDUNSnumber工廠名稱(chēng)、地址、FEI號(hào)、工廠鄧白氏號(hào)Confirmationwhetherthefacilitymanufactureshumandrugstha

18、tarenothumangenericdrugs確認(rèn)工廠是生產(chǎn)人用藥，而非人用仿制藥Backlog積壓費(fèi)ANDAapplicationnumberassignedbyFDAFDA給定的ANDA申請(qǐng)編號(hào)Establishednameofproduct產(chǎn)品名稱(chēng)Howarepaymentssubmitted?如何支付費(fèi)用？ApaymentmaybesubmittedbyP(electronicpayment),check,bankdraft,U.S.postalmoneyorder,orwiretransfer.Forallpaymentoptions,thepaymentmustbemadeinU

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

20、atFDAsothatthereisnodelayinstartingthereviewofyourapplicationsubmission.Pleasefollowtheinstructionsbelowforyourselectedpaymentoption:費(fèi)用可以通過(guò)P(電子支付)、支票、銀行匯票、美國(guó)郵政匯票或電匯方式支付。所有支付方式均應(yīng)以美元形式存入一家美國(guó)金融機(jī)構(gòu)。FDA建議及時(shí)支付用戶費(fèi)用，以免超期，或者保證在申請(qǐng)?zhí)峤磺笆盏礁犊?。提交申?bào)資料時(shí)，建議你在申報(bào)資料到達(dá)FDA之前4-5天進(jìn)行人工支付，以保證不會(huì)延遲對(duì)申報(bào)的審核。請(qǐng)根據(jù)下列指示選擇付費(fèi)方式：PaymentOpti

21、ons付費(fèi)方式Instructions付費(fèi)步驟P網(wǎng)上在線支付Pisaweb-basedpaymentapplicationthatallowselectronicpaymentstobemadedirectlyfromyourbankaccount.ApaymentcanbeinitiatedaftersubmittingyourcoversheetbyclickingthePayNowbuttonandfollowingtheon-screeninstructionstomakepayment.Topaylater,logintoyourGDUFAUserFeeaccountandacces

22、syourcoversheethistorypagebyclickingonthePreviousCoverSheetsiconatthetopofthepage.ClickthePayNowlinknexttotheUserFeePaymentI.D.Number(PIN)youneedtopayfor.P是一個(gè)在線支付工具，可以直接從你的帳號(hào)進(jìn)行電子支付。在提交封面頁(yè)后，點(diǎn)擊“PayNow”按鈕，根據(jù)屏幕上的提示進(jìn)行支付。如果要稍后支付，則登錄你的GDUFA用戶帳號(hào)，點(diǎn)擊頁(yè)面頂端PreviousCoverSheets進(jìn)入原來(lái)的封面頁(yè)，點(diǎn)擊你所需要支付的用戶費(fèi)用支付ID編號(hào)（PIN）旁的“P

23、ayNow”鏈接。PaymentmustbemadepayabletotheFoodandDrugAdministrationandmakereferencetotheUserFeePaymentI.D.Number(PIN).Thepaymentandacopyofyoursignedcoversheetmustbemailedtooneoftheaddressesshownbelow.費(fèi)用必須付至FDA,并可以索引至用戶費(fèi)用支付ID號(hào)(PIN)。費(fèi)用與簽字后的封面頁(yè)副本必須郵至以下地址之一。Check,BankDraft,orU.S.PostalMoneyOrder支票、銀行匯票或美國(guó)郵政

24、匯款Paymentsbymail郵件支付FoodandDrugAdministrationP.O.Box979108St.Louis,MO63197-9000Paymentsbycourier快遞支付U.S.BankAttention:GovernmentLockbox9791081005ConventionPlazaSt.Louis,MO63101Note:ContacttheU.S.Bankat(314)418-4013ifyouhaveanyquestionsconcerningdeliverybycourier.Contactyourfinancialinstitutionandpro

25、videthefollowinginformation:WireTransfer電匯BankName|TelegraphicName:銀行名稱(chēng)|電信公司名稱(chēng)U.S.DepartmentofTreasury|TREASNYCBankAddress:銀行地址33LibertyStreet|NewYork,NY10045AccountNumber:帳號(hào)75060099RoutingNumber:路由號(hào)碼021030004SWIFTNumber:FRNYUS33請(qǐng)與你們的金融機(jī)構(gòu)聯(lián)系，并給他們提供以下信息SWIFT代碼Beneficiary:FDA|1350PiccardDrive,Suite200A|Rockville,收款人MD20850Description:Referencet