2018FDA行业指南：优良ANDA申报规范（草案）

GoodANDASubmissionPractices

Guidance for Industry

行业指南：优良ANDA申报规范（草案）

DRAFTGUIDANCE

This guidance document is being distributed for comment purposes only.

Comments and suggesti** regardingthis draft document should be submitted within 60 days ofpublication in the Federal Register ofthe notice announcingtheavailabilityofthe draftguidance.  Submit electronic comments to https://www.regulati**.gov.Submit writtencomments to the DocketsManagement Staff(HFA-305), Foodand Drug Administration, 5630FishersLane, Rm. 1061, Rockville, MD20852.All comments should be identified with thedocket number listed in the notice ofavailabilitythat publishes in the Federal Register.

For questi** regardingthis draft document, contact (CDER)Lisa Bercuat240-402-6902.

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Drug Evaluation and Research (CDER)

January 2018 Generics

Additionalcopiesareavailablefrom:

OfficeofCommunicati**,DivisionofDrugInformationCenterforDrugEvaluationandResearch

FoodandDrugAdministration

10001NewHampshireAve.,HillandaleBldg.,4thFloorSilverSpring,MD20993-0002

Phone:855-543-3784or301-796-3400;Fax:301-431-6353

Email:druginfo@fda.hhs.gov

https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm

下载地址：：https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm591134.pdf

Good ANDA Submission Practices

GuidanceforIndustry[1]

行业指南：优良ANDA申报规范（草案）

This draftguidance, when finalized, willrepresentthecurrentthinkingofthe Food  and DrugAdministration (FDA orAgency)on this   topic.Itdoes not establish anyrights foranyperson and   is notbindingon FDA   orthepublic.  Youcan use   an alternative approach   ifitsatisfies   the requirementsoftheapplicablestatutesandregulati**.To discussan alternative approach,contactthe   FDA staffresp**ibleforthis guidance   as listed on thetitle   page.

本指南草案在定稿时将代表FDA对此主题当前的态度。它并不赋予任何人以任何权力，也不对FDA和公众形成约束。只要替代方法满足适用的法律法规要求，你可以使用替代方法。如需对替代方法进行讨论，请联系列在标题页的本指南FDA负责员工。

I.         INTRODUCTION概述

This guidance is intended to assist applicants preparingto submit to FDAabbreviated newdrugapplicati**(ANDAs).  This guidance highlightscommon, recurringdeficiencies that mayleadto adelayin the approvalof anANDA.  It also makes recommendati** to applicants on howtoavoid these deficiencieswith the goal ofminimizingthenumberof reviewcycles necessaryforapproval.

本指南意在帮助申报人准备给FDA的ANDA申报。本指南主要关注了可能会导致ANDA批准延迟的常见重复缺陷，也为申报人给出建议要如何避免这些缺陷，以尽可能减少批准所需的审评轮次。

Ingeneral, FDA’sguidance documents do not establish legallyenforceableresp**ibilities.Instead,guidancesdescribe the Agency’s current thinkingon atopic and should be viewed onlyas recommendati**, unless specific regulatoryorstatutoryrequirements are cited.Theuseofthe word should in Agencyguidances means thatsomethingis suggested or recommended, butnot required.

一般来说，FDA的指南文件并不建立法定强制义务，相反，指南所述的只是当局目前对某个主题的想法，除引用具体法规或法律要求外，均仅应作为建议看待。SHOULD一词在官方指南中表示建议或推荐某事但并非强制。

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[1] ThisguidancehasbeenpreparedbytheOfficeofGenericDrugsandtheOfficeofPharmaceuticalQualityintheCenterforDrugEvaluationandResearchattheFoodandDrugAdministration.本指南由FDA的CDER的OGD和OPQ办公室起草。

请问楼主，有中文版吗？