中美仿制药研发和申报流程概述专家讲座.pptx

药品经济学催生美国仿制药制度1984年后NDA研发和申报505(b)(1)新药申报资料内容6.HumanPharmacokineticsandBioavailability7.Microbiology(foranti-microbialdrugsonly)8.ClinicalData9.SafetyUpdatereport(typicallysubmitted120daysaftertheNDA’ssubmission)10.Statistical11.CaseReportTabulations12.CaseReportForms13.PatentInformation14.PatentCertification505(b)(2):历史过程505(b)(2)关键:可靠性505(b)(2)意义505(b)(2)范围505(b)(2)情形505(b)(2)排他性505(b)(2)新药成功例子505(b)(2)新药例子505(b)(2)新药例子505(b)(2)新药例子FDANDA审评过程FDA能够使用已经有数据用于审评NDA吗？美国仿制药Genericdrugapplicationsaretermed“abbreviated”inthattheyaregenerallynotrequiredtoincludepreclinical(animal)andclinical(human)datatoestablishsafetyandeffectiveness.Theseparameterswereestablishedupontheapprovaloftheinnovatordrugproduct,whichisthefirstversionofthedrugproductapprovedbytheFDA.FDA审评仿制药程序二、美国仿制药申报、审评和研发对策中美仿制药研发和申报流程概述专家讲座中美仿制药研发和申报流程概述专家讲座中美仿制药研发和申报流程概述专家讲座OfficeofGenericDrugs怎样确保审评质量和效率？NewresourcesdevelopedDissolutionDatabaseIndividualProductBioequivalenceInformationEncouragedtheuseoftelephoneinreviewprocessIncreasedthenumberof1stcycleapprovalsDecreasedthetotalnumberofreviewcyclesTotaltimetoapprovaldidnotincreaseinspiteofincreasedworkloadDissolutionMethodsforDrugProductsben中美仿制药研发和申报流程概述专家讲座ThisguidancecontainsanInternetlinktoalistingofdrugproducts,eachlinkedinturntoacorrespondingbioequivalencerecommendation.Clickingonaproductnameinthatlistwillbringupthebioequivalencerecommendationsforthatspecificproduct.Recommendationshavebeendevelopedforseveraldrugsthatarenotyeteligibleforgenericcompetition(i.e.,newlyapprovedproducts)andsomeolderproductsforwhichinformationhaspreviouslybeenprovided.Asadditionalrecommendationsaredeveloped,thosewillbepostedontheWebsite.Whenthisguidanceisfinalized,thelistingwillbeavailablethroughtheAgency’sWebpage.OFFICEOFGENERICDRUGSQbR:从提出到完善QbR内涵ANDAsUnderQbR(Continued)新药申报（NDA）和仿制药申报（ANDA）比较美国仿制药申报OGDQBRThequestionbasedreview(QBR)servesasageneralframeworkfortheCMCassessmentofANDAsthatfocusesoncriticalpharmaceuticalattributesofproductquality.Withjustification,deviationsor