行業(yè)指南ANDA申報(bào)拒收標(biāo)準(zhǔn)RTRStandardsguidancerevisionDecember中英文完

1、ANDA SubmissionsRefuse-to-Receive StandardsGuidance for Industry行業(yè)指南： ANDA 申報(bào) - 拒收標(biāo)準(zhǔn)U.S. Department of Health and Human Services Food and DrugAdministrationCenter for Drug Evaluation and Research (CDER)December 2016GenericsRevision 2ANDA SubmissionsRefuse-to-ReceiveStandards Guidance for IndustryAND

2、A SubmissionsRefuse-to-Receive StandardsGuidance for Industry行業(yè)指南： ANDA 申報(bào) - 拒收標(biāo)準(zhǔn)Additional copies are available from:更多副本請(qǐng)從以下獲?。篛ffice of Communications, Division of Drug InformationCenter for Drug Evaluation andResearchFood and Drug Administrationth10001 New Hampshire Ave., Hillandale Bldg., 4Floo

3、r Silver Spring, MD 20993-0002Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353Email: /Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htmU.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Re

4、search (CDER)美國(guó)衛(wèi)生福利部食品藥品管理局（FDA ）化藥審評(píng)中心（ CDER ）December 20162016 年 12 月Generics仿制藥Revision 2第二版ANDA SubmissionsRefuse-to-ReceiveStandards Guidance for Industry目錄INTRODUCTION概述4BACKGROUND背景5GENERAL POLICY通則6A.Form FDA 356h (356h) FDA365h表格 (365h)8B.Submission, Format, and Organization申報(bào)資料、格式和文件結(jié)構(gòu)8C.N

5、on-Payment of GDUFA Obligations未付清 GDUFA 費(fèi)用8D.Lack of a Designated U.S. Agent for a Foreign Applicant外國(guó)申請(qǐng)人未指定美國(guó)代理人9E.Citing a Pending Suitability Petition as a Basis of Submission引用尚未裁決的適用性請(qǐng)?jiān)缸鳛樯陥?bào)的基礎(chǔ)9REVIEWS FOR API原料藥評(píng)審10A.Starting Material起始物料10B.Sterility Assurance Data無(wú)菌保證數(shù)據(jù)10PRODUCT QUALITY DEFI

6、CIENCIES藥品質(zhì)量缺陷10A.Inactive Ingredients非活性成分10B.Inadequate Stability穩(wěn)定性不充分13C.Packaging Amount Considerations包裝數(shù)量考慮15D.Batch Records 批記錄15E.Method Validation/Verification Reports分析方法驗(yàn)證 /確認(rèn)報(bào)告15F.Special Consideration for Transdermal Patches對(duì)透皮貼劑的特殊考慮16G.Scoring and Conditions of Use 刻痕與使用條件17H.Microbi

7、ology Considerations微生物學(xué)考慮19BIOEQUIVALENCE AND CLINICAL DEFICIENCIES生物等效性和臨床缺陷20A.Failed In Vivo BE Studies體內(nèi) BE 研究失敗20B.Alternate BE Studies 替代 BE 研究20C.Q1/Q2 Sameness Requirement for Consideration of an In Vivo BE Study Waiver20D.Inadequate Dissolution Data (In Vitro Studies)溶出不充分（體外研究）21E.Miscell

8、aneous Factors 其它因素22DISPUTE OF A REFUSE-TO-RECEIVE DECISION對(duì)于拒收決定的爭(zhēng)議24APPENDIX A:EXAMPLES OF MINOR DEFICIENCIES附錄 A ：輕微缺陷舉例25FDA行業(yè)指南： ANDA 申報(bào) -拒收標(biāo)準(zhǔn) 201612翻譯： Julia頁(yè) 3 / 27ANDA SubmissionsRefuse-to-ReceiveStandards Guidance for IndustryANDA SubmissionsRefuse-to-Receive StandardsGuidance for Industry

9、1行業(yè)指南： ANDA 申報(bào) - 拒收標(biāo)準(zhǔn)This guidance represents the current thinking of the Food and Drug Administration (FDA orAgency) onthis topic. It does not establish any rights for any person and is not binding on FDAor the public.You can use an alternative approach if it satisfies the requirements of theapplic

10、able statutes and regulations.To discuss an alternative approach, contact the FDA officeresponsible for this guidance as listed on thetitle page.本指南代表了FDA 目前對(duì)此主題的想法。指南并未賦予任何人任何權(quán)力，對(duì)FDA 和公眾均不具備約束力。如果滿足適用的法律和法規(guī)要求，可以使用其它的替代方法。如需對(duì)替代方法進(jìn)行討論，請(qǐng)聯(lián)系本指南標(biāo)題頁(yè)上列出的FDA 負(fù)責(zé)辦公室。INTRODUCTION概述This guidance is intended to

11、assist applicants preparing to submit to FDA abbreviated new drugapplications (ANDAs) and prior approval supplements (PASs) to ANDAs for which theapplicant isseeking approval of a new strength of the drug product2 .The guidance highlightsdeficiencies thatmay cause FDA to refuse to receive (RTR) an A

12、NDA3 . An RTR decisionindicates that FDAdetermined that an ANDA is not substantially complete4 .A substantiallycomplete ANDA is“ anANDAthat on its face is sufficiently complete topermit a substantivereview.5”本指南旨在幫助申報(bào)人為了獲得藥品新劑量而準(zhǔn)備向FDA 提交簡(jiǎn)略新藥申報(bào)（ ANDA ）和 ANDA 預(yù)批準(zhǔn)補(bǔ)充申報(bào)（ PAS ）。本指南著重說(shuō)明了可能會(huì)導(dǎo)致FDA 拒收（ RTR ）一

13、份 ANDA 的缺陷。 RTR 決定表示 FDA 判定一份 ANDA 不是實(shí)質(zhì)上完整的。實(shí)質(zhì)上完整的ANDA 是 “表面足夠完整的ANDA ，可以開始進(jìn)行實(shí)質(zhì)性評(píng)審 ”。This guidance is not meant to be a comprehensive list of the deficiencies that may or will lead toanRTR determination by FDA. Instead, this guidance identifies certain deficiencies and certainrecurrentdeficiencies t

14、hat in FDAsexperience have led FDA to RTR an ANDA.This guidance also describeshow FDA will assess deficiencies identified during FDAsfiling review todetermine whether an ANDAshould be received. We note that industry is aware of many of thestandards described in thisguidance because FDA has historica

15、lly applied many of thesestandards in its RTR determinations.本指南無(wú)意成為一份可能會(huì)或可能引發(fā)FDA 的 RTR 決定的所有缺陷清單。相反，本指南只是指出根據(jù)FDA 經(jīng)驗(yàn)已經(jīng)導(dǎo)致 FDA 拒收 ANDA 的一些缺陷和反復(fù)發(fā)生的缺陷。本指南還描述了FDA 將如何評(píng)估在FDA 歸檔審核期間所發(fā)現(xiàn)的缺陷，以確定是否應(yīng)接受該ANDA 。我們注意到制藥行業(yè)其實(shí)明白在本指南中所述的許多標(biāo)準(zhǔn)，因?yàn)镕DA 已經(jīng)在其 RTR 決定中采用了這些標(biāo)準(zhǔn)。FDAsguidance documents, including this guidance, gen

16、erally do not establish legallyenforceableresponsibilities. Instead, guidancesdescribe FDAscurrent thinking on a topic andshould be viewedonly as recommendations, unless specific regulatory or statutory requirementsare cited.1 This guidance has been prepared by the Office of Generic Drugs in the Cen

17、ter for Drug Evaluation and Researchtheat Food and Drug Administration.本指南由食品藥品管理局（ FDA ）的化藥評(píng)審中心（ CDER）的仿制藥辦公室（ OGD）起草制訂。2 For purposes of this guidance, the use of the term“ ANDA” will mean ANDAs and new-strength PASsubmissions.在本指南中， ANDA 一詞代表 ANDA 和新劑量 PAS 申報(bào)。3 An RTR determination should not be

18、confused with a refuse-to-approve determination.不應(yīng)將拒收（ RTR）決定與拒絕批準(zhǔn)決定相混淆。4 21 CFR 314.101(b)(1).5 21 CFR 314.3(b).FDA行業(yè)指南： ANDA 申報(bào) -拒收標(biāo)準(zhǔn) 201612翻譯： Julia頁(yè) 4 / 27ANDA SubmissionsRefuse-to-ReceiveStandards Guidance for IndustryFDA 的指南文件，包括本指南，通常并不會(huì)產(chǎn)生法定強(qiáng)制義務(wù)。相反，指南只是描述FDA 當(dāng)前對(duì)某個(gè)主題的態(tài)度，除了所引用的特定法規(guī)或法律要求外，其它內(nèi)容應(yīng)被

19、當(dāng)作是建議。The use of the word “ should in”Agency guidances means that something is suggested or recommended, but not required 6.FDA 指南中使用 “ SHOULD”一詞時(shí)表示的是建議或推薦某事，但并不是強(qiáng)制要求。BACKGROUND背景Pursuant to the enactment of the Generic Drug User Fee Amendments of 2012 (GDUFA)7, the Officeof Generic Drugs (OGD) is t

20、asked with a number of activities, including the developmentof “ enhancedrefusal to receive standards for ANDAs and other related submissions by the endof year 1 of the8submitting an ANDAprogram . ” Enhanced RTR standards are important because the practice ofthat is not sufficiently complete to perm

21、it a substantive review and then“ repairing it in”the course of anextended review period that needs several cycles of FDAresponse and applicant repair is inherentlyinefficient and wasteful of resources. In addition,ANDAs that are not sufficiently complete to permit asubstantive review generate extra

22、 reviewsand letters.隨著 2012 年 GDUFA 法案的實(shí)施，仿制藥辦公室（OGD ）承擔(dān)了一系列活動(dòng)任務(wù)，包括“到計(jì)劃開始的第 1 年底建立加強(qiáng) ANDA 和其它相關(guān)申報(bào)資料的拒收標(biāo)準(zhǔn) ”。由于提交一份不夠完整而無(wú)法進(jìn)行實(shí)質(zhì)性評(píng)審的 ANDA ，然后在深入審核期間進(jìn)行“修補(bǔ) ”，會(huì)需要多輪FDA 反饋和申報(bào)者修補(bǔ)，這樣會(huì)降低效率，浪費(fèi)資源，因此加強(qiáng)RTR 標(biāo)準(zhǔn)是很重要的。另外，不夠完整而無(wú)法進(jìn)行實(shí)質(zhì)性審核的ANDA 會(huì)產(chǎn)生額外的審核和信函。FDA evaluates each submitted ANDA individually to determine whethe

23、r the ANDA can bereceived.The receipt of an ANDA means that FDA made a threshold determination that theANDA is asubstantially complete application, that is, an ANDA that on its face is sufficientlycomplete to permit asubstantive review 9 . Sufficiently complete means that the ANDA containsall the in

24、formation requiredunder section 505(j)(2)(A)of the Federal Food,Drug, and Cosmetic Act (FD&C Act) and does notcontain a deficiency described in 21 CFR 314.101(d)and (e) 10.FDA 會(huì)對(duì)收到的 ANDA 逐個(gè)評(píng)估，以確定是否可以接受。接受一份ANDA 意味著 FDA 做出了一個(gè)決定，確定該 ANDA 是否是一份實(shí)質(zhì)性完整的申報(bào)資料，也就是該ANDA 表面上足夠完整，可以開始實(shí)質(zhì)性評(píng)審。足夠完整意味著 ANDA 包括了所有根據(jù)

25、FDCA 505(j)(2)(A)部分中所要求的所有資料，并且沒(méi)有21 CFR314.101(d) 和 (e) 里所述的缺陷。Our regulations at 21 CFR 314.101 provide the regulatory authority by which FDA may incertain cases,and will in others, RTR an ANDA that does not satisfy the criteria for a thresholddetermination that the6 At various points in this guida

26、nce, it is noted that when a particular type of deficiency in an ANDA is seen, FDAwill RTR the ANDA. It is important to understand that these statements do not create legal obligations, applicantson or on FDA, but rather are included for purposes of transparencyThis. means that FDA, in the normal co

27、urse, will RTR anANDA on the grounds described in this guidance.This guidance does not preclude thepossibility that an ANDA applicant may be able to demonstrate, in particular circumstances, that the regulatoryrequirements for receiving an ANDA have been met even when, as described in this guidance,

28、 FDA would in thenormal course find the application not sufficiently complete to permit a substantive review andRTR it.在本指南的不同地方，要注意如果FDA 在一份 ANDA 中發(fā)現(xiàn)了某種類型的缺陷，則會(huì)拒收該ANDA 。因此，理解這些聲明并不對(duì)申報(bào)人或FDA 產(chǎn)生任何法律義務(wù)，而只是為了使得程序更為透明。這意味著FDA 在通常程序下會(huì)根據(jù)本指南所述拒收某份ANDA 。本指南并不排除ANDA 申報(bào)人可能在特殊情形下證明一份ANDA符合本指南中所述的法規(guī)接收要求，但 FDA 仍在

29、正常流程中發(fā)現(xiàn)申報(bào)資料不夠完整無(wú)法開始實(shí)質(zhì)性評(píng)審，從而拒收的可能性。7 Generic Drug User Fee Amendments of 2012 (GDUFA) (Public Law 112-144, Title III).2012年仿制藥用戶費(fèi)用修正案（GDUFA ）（公共法 112-114，標(biāo)題 III ）。8 See Generic Drug User Fee Act Program Performance Goals and Procedures:/downloads/ForIndustry/UserFees/GenericDrugUserF

30、ees/UCM282505.pdf.參見(jiàn)仿制藥費(fèi)用法案項(xiàng)目績(jī)效目標(biāo)和程序。9 See 21 CFR 314.101(b)(1) and 314.3(b).10 21 CFR 314.3(b).FDA行業(yè)指南： ANDA 申報(bào) -拒收標(biāo)準(zhǔn) 201612翻譯： Julia頁(yè) 5 / 27ANDA Submissions Refuse-to-ReceiveStandards Guidance for Industryapplication is substantially complete11 .我們?cè)?21 CFR 314.101 中的法規(guī)要求讓 FDA 有權(quán)在某些情形下可以拒收不滿足確定申報(bào)資料

31、實(shí)質(zhì)性完整標(biāo)準(zhǔn)的 ANDA 。Between Fiscal Years (FY) 2013 to 2015, FDA refused to receive 379 ANDAs for reasons otherthanfailure to pay a GDUFA fee.Of all original ANDA submissions, FDA refused to receive:在 2013 財(cái)年至 2015 財(cái)年之間， FDA 由于 GDUFA 費(fèi)用支付以外的原因拒收了379 份 ANDA 。在所有ANDA 初始申報(bào)中， FDA 拒收比例為：14% in FY 201310% in FY

32、 201414% in FY 2015 122013財(cái)年： 14%2014財(cái)年： 10%2015財(cái)年： 14%In FY 2015, the five most frequent bases for an RTR determination were (in order of frequency):inadequate stability data; incomplete information request response; inadequate dissolution; drugproduct was not qualitatively and quantitatively the s

33、ame (Q1/Q2 same) as the reference listed drug (RLD); and failure to respond to information request within the prescribed timeframe).在2015 財(cái)年， RTR 決定最頻繁的 5 個(gè)原因（根據(jù)其頻繁程度）為：穩(wěn)定性數(shù)據(jù)不充分、所需回復(fù)信息不完整、溶出度不充分、制劑定量或定性方面與 RLD 參比制劑不相同（ Q1/Q2 相同），以及未能在指定時(shí)間內(nèi)回復(fù)所要求的資料。GENERAL POLICY通則FDA considers the nature (e.g., majo

34、r or minor) of the deficiencies, including the number ofdeficiencies in the ANDA, in determining whether an ANDA is incomplete on its face13 . During FDAsfiling review of a submitted ANDA, FDA will determine if there are any major or minordeficiencies.Generally, a major deficiency is one that inFDAs

35、judgment is significant in naturesuch as certaindeficiencies found in 21 CFR 314.101(d) or 21 CFR 314.101(e)14 ; other majordeficiencies arediscussed in this and other guidances.Numerous minor deficiencies (discussedbelow) also constitutea major deficiency. A major deficiency will result in a determ

36、ination byFDA that the ANDA isincomplete on its face under 21 CFR 314.101(d)(3), and FDA willtherefore RTR an ANDA containing amajor deficiency.FDA 在決定一份 ANDA 是否表面完整的時(shí)候，會(huì)考慮ANDA 中缺陷的情況，包括缺陷的數(shù)量。在FDA對(duì)提交的 ANDA 進(jìn)行歸檔審核期間，F(xiàn)DA 會(huì)決定是否有重大缺陷或輕微缺陷。通常，重大缺陷是FDA認(rèn)為比較嚴(yán)重的情況，例如發(fā)現(xiàn)違反21 CFR 314.101(d)或 21 CFR 314.101(e)中要

37、求的某些缺陷，其它的重大缺陷將在本指南和其它指南中進(jìn)行討論。大量輕微缺陷（以下將進(jìn)行討論）也會(huì)構(gòu)成重大缺陷。11 See 21 CFR 314.101(d)-(e).12 See FY 2015 Performance Report to Congress for the Generic Drug User Fee Amendments, available at /downloads/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/PerformanceReports/UCM493026.pdf.參見(jiàn)

38、2015 財(cái)年 FDA 呈交議會(huì)的仿制藥費(fèi)用修訂案績(jī)效報(bào)告，可以從上述網(wǎng)址獲得。13 21 CFR 314.101(d)(3).14 Pursuant to 21 CFR 314.101(d), FDA“ may”not consider an ANDA to be received if any of the deficiencies under that regulation applies.FDA will determine on a case-by-case basis whether a deficiency under certainprovisions of 314.101(d

39、) is a major or minor deficiency, in accordance with the principles described in this guidance.根據(jù) 21 CFR 314.101(d)，如果根據(jù)適用的法規(guī)被判定為缺陷，則 FDA 可以認(rèn)為該 ANDA 不能被接收。 FDA 會(huì)按照本指南中所述的原則，依據(jù) 314.101(d)的某些條款各案決定一個(gè)缺陷是重大缺陷還是輕微缺陷。FDA行業(yè)指南： ANDA 申報(bào) -拒收標(biāo)準(zhǔn) 201612翻譯： Julia頁(yè) 6 / 27ANDA Submissions Refuse-to-ReceiveStandards

40、 Guidance for Industry一個(gè)重大缺陷就會(huì)使得FDA 依據(jù) 21 CFR 314.101(d)(3) 判定該 ANDA 是表面不完整的，因此FDA 將會(huì)RTR 含有一個(gè)重大缺陷的ANDA 。A minor deficiency is one that inFDAsjudgment is minor in nature and can be easilyremedied 15. As aresult, FDA will allow the applicant a prescribed time period (described belowin this section) to

41、 providea response to such deficiencies. In particular, if FDA determines thatan ANDA contains fewer thanten minor deficiencies (i.e., nine deficiencies or fewer), FDA willnotify the applicant of the deficiencies,by phone, fax, or through the primary method forcommunication, which is email. FDA, in

42、its discretion,provides applicants with the opportunityto correct minor deficiencies or amend the ANDA, withinseven (7) calendar days16 .If within 7calendar days the requested information is not received, FDAwill RTR the ANDA.輕微缺陷是指 FDA 認(rèn)為情況比較輕微，很容易補(bǔ)正的缺陷。因此，F(xiàn)DA 會(huì)允許申報(bào)者在指定時(shí)間段內(nèi)（在本部分的以下部分說(shuō)明）提交對(duì)這些缺陷的回復(fù)。尤

43、其是如果FDA 確定一份 ANDA 含有小于 10 個(gè)輕微缺陷的時(shí)候（即， 9 個(gè)缺陷或更少），則FDA 會(huì)通過(guò)電話、傳真、或基本溝通方法即電子郵件方式將這些缺陷告知申報(bào)者。在通知中，F(xiàn)DA 會(huì)告知申報(bào)人在 7 個(gè)自然日內(nèi)有機(jī)會(huì)糾正輕微缺陷或修訂ANDA 。如果在 7 個(gè)自然日內(nèi)沒(méi)有收到所索取的信息，F(xiàn)DA 則會(huì)拒收該 ANDA 。However, if FDA determines that an ANDA contains ten or more minor deficiencies or one or moremajor deficiencies, FDA will not consid

44、er the ANDA to bea substantially complete application under21 CFR 314.101(b)(1). In such cases, FDA will notify the applicant that FDA considers theANDA notto have been “ received. If”the applicant decides to submit additional materials tocorrect thedeficiencies, the resulting amended ANDA will be c

45、onsidered a new ANDAsubmission, received as ofthe date the amended ANDA is submitted (if deemed substantiallycomplete), and the applicant will berequired to pay a new ANDA fee. If an ANDA is notreceived and the applicant takes no action, FDAmay consider the ANDA withdrawn after 1year 17. An ANDAappl

46、icant sfailure to take action after arefuse-to-receive decision on anANDA may be considered a request by the applicant to withdraw theANDA, unless the applicant requests an extension of time in which to resubmit the ANDA18 . Theremay be circumstances, however, under which an exception to, or a waive

47、r of, a regulatory requirementmay be granted. FDA will consider the merits of such circumstances on a case-by-case basis19 .但是，如果 FDA 認(rèn)為一份 ANDA 中含有 10個(gè)或更多輕微缺陷，或1 個(gè)或更多重大缺陷，則FDA 會(huì)認(rèn)為該 ANDA 根據(jù)是 21 CFR 314.101(b)(1)實(shí)質(zhì)不完整的。在此情形下，F(xiàn)DA 會(huì)通知申報(bào)人FDA 將視該ANDA 為未被接收。如果申報(bào)人決定提交更多資料來(lái)糾正這些缺陷，則所導(dǎo)致的修訂后的ANDA 會(huì)被當(dāng)作一份新的 ANDA

48、來(lái)處理，修訂后的ANDA 提交日期會(huì)被作為是申報(bào)接收日期（如果修訂后的資料是實(shí)質(zhì)性完整的話）， FDA 會(huì)要求申報(bào)人支付一份新ANDA 的費(fèi)用。如果提交的ANDA 沒(méi)有被接受，而申報(bào)人在收到 ANDA 被拒收的決定后又沒(méi)有采取措施，除申報(bào)人申請(qǐng)延期提交ANDA 以外，視作申報(bào)人要求撤回該 ANDA 。當(dāng)然，也有一些情形下會(huì)有例外，或者是豁免，這時(shí)FDA 會(huì)各案考慮此種情形。The following sections discuss deficiencies that FDA considers to be major deficiencies.Aselection ofminor defic

49、iencies is provided in Appendix A.下節(jié)討論 FDA 認(rèn)為重大的缺陷。附錄A 中給出了輕微缺陷項(xiàng)目。15 Though the focus of this guidance is to highlight major deficiencies, select minor deficiencies are listed inAppendixA the list is not a comprehensive list of minor deficiencies.盡管本指南重點(diǎn)是強(qiáng)調(diào)重大缺陷，但在附錄A 中仍列出了一些輕微缺陷-該清單并不是輕微缺陷的窮盡列表。16 T

50、he response period will begin the day after notification is providedIf. the 7th calendar day falls on a Saturday, Sunday, or Federal holiday, the deadline for amending the ANDA to correct the deficiencies will be the next day that is not a Saturday, Sunday, or Federal holiday.回復(fù)期限從發(fā)出通知日起算。如果第 7 個(gè)自然日

51、是周六、周日或聯(lián)邦假日，則補(bǔ)正 ANDA 的時(shí)間期限依次順延至周末或假期后第一個(gè)工作日。17 21 CFR 314.101(b)(3)(iii).18 Abbreviated New Drug Applications and 505(b)(2) Applications; Final Rule, 81 FR 69580, 69622 (October 6,2016). 簡(jiǎn)略新藥申報(bào)和 505(b)(2)申報(bào)。最終規(guī)則 ，81FR 69580, 69622 (2016年 10 月 6 日)19 21 CFR 314.99(b).FDA行業(yè)指南： ANDA 申報(bào) -拒收標(biāo)準(zhǔn) 201612翻譯：

52、Julia頁(yè) 7 / 27ANDA Submissions Refuse-to-ReceiveStandards Guidance for IndustryA. Form FDA 356h (356h) FDA365h表格 (365h)An ANDA must contain a completed application form (i.e., Form FDA 356h). If this form is notincluded,or is not signed, which indicates that the applicant is not attesting to the mate

53、rialcontained in theapplication, FDA will RTR the ANDA20 .申請(qǐng)必須包含一份完整的申請(qǐng)表格（即FDA 356h表格）。如果申報(bào)資料中該表缺失，或者是表格沒(méi)有簽字，則表示申報(bào)人沒(méi)有證明申報(bào)中所包含的資料，則FDA 會(huì)拒收該 ANDA 。B. Submission, Format, and Organization申報(bào)資料、格式和文件結(jié)構(gòu)The ANDA should be formatted according to the eCTD format, and it should be submittedelectronicallyfor GDUFA metric goals to apply to the ANDA2