中美仿制药研发申报流程.ppt

中美仿制药研发和申报流程我国仿制药申报、审评和研发对策药物经济学催生美国仿制药制度1984年后NDA的研发和申报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)的关键:可靠性505(b)(2)的意义505(b)(2)范围505(b)(2)情形505(b)(2)排他性505(b)(2)新药的成功例子505(b)(2)新药的例子505(b)(2)新药的例子505(b)(2)新药的例子FDANDA审评过程FDA可以使用已有数据用于审评NDA吗？美国仿制药Genericdrugapplicationsaretermed“abbreviated”inthattheyaregenerallynotrequiredtoincludepreclinical(animal)andclinical(human)datatoestablishsafetyandeffectiveness.TheseparameterswereestablishedupontheapprovaloftheinnovatordrugproductwhichisthefirstversionofthedrugproductapprovedbytheFDA.FDA审评仿制药程序二、美国仿制药的申报、审评和研发对策OfficeofGenericDrugs如何保证审评质量和效率？NewresourcesdevelopedDissolutionDatabaseIndividualProductBioequivalenceInformationEncouragedtheuseoftelephoneinreviewprocessIncreasedthenumberof1stcycleapprovalsDecreasedthetotalnumberofreviewcyclesTotaltimetoapprovaldidnotincreaseinspiteofincreasedworkloadDissolutionMethodsforDrugProductsbenThisguidancecontainsanInternetlinktoalistingofdrugproductseachlinkedinturntoacorrespondingbioequivalencerecommendation.Clickingonaproductnameinthatlistwillbringupthebioequivalencerecommendationsforthatspecificproduct.Recommendationshavebeendevelopedforseveraldrugsthatarenotyeteligibleforgenericcompetition(i.e.newlyapprovedproducts)andsomeolderproductsforwhichinformationhaspreviouslybeenprovided.AsadditionalrecommendationsaredevelopedthosewillbepostedontheWebsite.WhenthisguidanceisfinalizedthelistingwillbeavailablethroughtheAgency’sWebpage.OFFICEOFGENERICDRUGSQbR:从提出到完善QbR的内涵ANDAsUnderQbR(Continued