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AbbreviatedNewDrugApplicationProcess/仿制药的简略新药申请程序第1页共7页PreparedbySelina0515QQ:609759720仿制药的简略新药申请程序（ANDAProcess）•前言•简略新药申请的指南文件•法律，法规，政策和程序o美国联邦法典o政策和程序手册•ANDA表格和电子申请•药品开发和评审定义•药品开发方面的常见问题•相关主题前言AnAbbreviatedNewDrugApplication(ANDA)containsdatawhichwhensubmittedtoFDA'sCenterforDrugEvaluationandResearch,OfficeofGenericDrugs,providesforthereviewandultimateapprovalofagenericdrugproduct.简略新药申请（ANDA）所包括的资料被交至FDA药品评审和研究中心所属的仿制药办公室，用于仿制药的评审和最终批准。Onceapproved,anapplicantmaymanufactureandmarketthegenericdrugproducttoprovideasafe,effective,lowcostalternativetotheAmericanpublic.一旦批准，则申请者可以生产和销售该仿制药以向美国公众提供安全，有效，廉价的替代品。Agenericdrugproductisonethatiscomparabletoaninnovatordrugproductindosageform,strength,routeofadministration,quality,performancecharacteristicsandintendeduse.仿制药在剂型，剂量，服用方式，质量，性能特征和用途方法都是和原创药物相当的。Allapprovedproducts,bothinnovatorandgeneric,arelistedinFDA'sApprovedDrugProductswithTherapeuticEquivalenceEvaluations(OrangeBook).所有被批准的药品，包括原创药和仿制药都列在FDA的具有相当疗效评估的已批准药品（橙皮书）上。Genericdrugapplicationsaretermedabbreviatedbecausetheyaregenerallynotrequiredtoincludepreclinical(animal)andclinical(human)datatoestablishsafetyandeffectiveness.仿制药申请被称为“简略申请”，是因为它们基本上不需要临床前资料（动物实验）和临床资料（人体实验）来建立安全性的有效性。Instead,genericapplicantsmustscientificallydemonstratethattheirproductisbioequivalent(i.e.,performsinthesamemannerastheinnovatordrug).仿制药申请者必须要科学地论述他们的产品是生物等效的（也就是，和原创药同样的性能表现）Onewayscientistsdemonstratebioequivalenceistomeasurethetimeittakesthegenericdrugtoreachthebloodstreamin24to36healthy,volunteers.科学家论证生物等效性的一种方法就是测定仿制药到达24￣36位健康志愿者血流中的时间。Thisgivesthemtherateofabsorption,orbioavailability,ofthegenericdrug,whichtheycanthencomparetothatoftheinnovatordrug.这个实验给出AbbreviatedNewDrugApplicationProcess/仿制药的简略新药申请程序第2页共7页PreparedbySelina0515QQ:609759720仿制药的吸收率（rateofabsorption）或者生物利用度，因此仿制药就可以凭此与原创药进行比较。Thegenericversionmustdeliverthesameamountofactiveingredientsintoapatient'sbloodstreaminthesameamountoftimeastheinnovatordrug.仿制药必须和原创药在同样的时间内将同样量的活性成分传输到患者的血流。UsingbioequivalenceasthebasisforapprovinggenericcopiesofdrugproductswasestablishedbytheDrugPriceCompetitionandPatentTermRestorationActof1984,alsoknownastheWaxman-HatchAct.把生物等效性作为批准仿制药的基础是根据1984年的药品价格竞争和专利恢复法案,，来确立的，该法案也被称之为维克斯曼－哈奇法案。ThisActexpeditestheavailabilityoflesscostlygenericdrugsbypermittingFDAtoapproveapplicationstomarketgenericversionsofbrand-namedrugswithoutconductingcostlyandduplicativeclinicaltrials.本法令通过允许FDA批准品牌药的仿制版本的上市而无需进行昂贵和重复性的临床试验来加快较便宜的仿制药的获得。Atthesametime,thebrand-namecompaniescanapplyforuptofiveadditionalyearslongerpatentprotectionforthenewmedicinestheydevelopedtomakeupfortimelostwhiletheirproductsweregoingthroughFDA'sapprovalprocess.同时，品牌药厂家也可以为他们所开发的新药申请五年的专利保护延期以弥补他们产品在通过FDA批准过程所损失的时间。Brand-namedrugsaresubjecttothesamebioequivalencetestsasgenericsuponreformulation.品牌药在改变配方时也要进行和仿制药一样的生物等效性实验。Formoreinformationongenericdrugbioequivalencyrequirements,pleaseseethechapterentitledFDAEnsuresEquivalenceofGenericDrugsinFromTestTubetoPatient:ImprovingHealthThroughHumanDrugs.关于仿制药生物等效性方面要求的更多信息，请参见从试管到患者：通过药品提高健康.TheOfficeofGenericDrugshomepageprovidesadditionalinformationtogenericdrugdevelopers,includinganinteractiveflowchartpresentationoftheANDAreviewprocess,focusingonhowCDERdeterminesthesafetyandbioequivalenceofgenericdrugproductspriortoapprovalformarketing.仿制药办公室的主页为仿制药开发者提供了更多的信息，包括一个互动性的ANDA评审过程流程图，重点在于CDER在批准仿制药上市前是如何确定其安全性和生物等效性的。Genericdrugapplicationreviewersfocusonbioequivalencedata,chemistryandmicrobiologydata,requestsforplantinspection,anddruglabelinginformation.仿制药申请的的评审官着重于生物等效性资料，化学和生物资料，工厂检查的要求和药品标签信息等。Thiswebsiteisdesignedforindividualsfrompharmaceuticalcompanies,governmentagencies,academicinstitutions,privateorganizations,orotherorganizationsinterestedinbringingagenericdrugtomarket.本网址是为来自制药企业，政府机关，学术单位，私营组织或其它组织中对将仿制药带入市场感兴趣的个人而设计的。EachofthesectionsbelowcontainsinformationfromCDERtoassistyouintheANDAapplicationprocess.下面的每一个章节都包括了来自CDER的信息以为你在ANDA申请过程中提供帮助。Clickonalinktogodirectlytoasection.点击链接直接进入相应的章节。ResourcesforANDASubmissionsAbbreviatedNewDrugApplicationProcess/仿制药的简略新药申请程序第3页共7页PreparedbySelina0515QQ:609759720ANDA递交方面的资源ThefollowingresourceshavebeengatheredtoprovideyouwiththelegalrequirementsofanANDAapplication,assistancefromCDERtohelpyoumeetthoserequirements,andinternalANDAreviewprinciples,policiesandprocedures.如下资源集中在一起为你提供了ANDA申请的法律要求，来自于CDER的支持以帮助你满足他们的要求，ANDA的内部评审原则，政策和程序。GuidanceDocumentsforANDAsANDA方面的指导文件GuidancedocumentsrepresenttheAgency'scurrentthinkingonaparticularsubject.指导文件代表了FDA对某一主题的当前看法。ThesedocumentsarepreparedforFDAreviewstaffandapplicants/sponsorstoprovideguidelinestotheprocessing,content,andevaluation/approvalofapplicationsandalsotothedesign,production,manufacturing,andtestingofregulatedproducts.这些文件旨在为FDA评审人员和申请者/发起人(Sponsor)在申请的内容整理，评审/批准等方面提供指南，同时也为受管产品的设计，生产，制造和测试等方面提供指南。TheyalsoestablishpoliciesintendedtoachieveconsistencyintheAgency'sregulatoryapproachandestablishinspectionandenforcementprocedures.他们也建立政策以获得FDA法规方法方面的一致性，并建立检查和执行程序。Becauseguidancesarenotregulationsorlaws,theyarenotenforceable,eitherthr