中美仿制药研发申报流程图.ppt

文档介绍：中美仿制药研发和申报流程涂家生,:025-83271305Email:******@、审评和研发对策主要内容中美关于原研药和仿制药的背景美国仿制药:申报、panyLogo*药物经济学催生美国仿制药制度美国社会安全制度导致政府赤字严重SSA已经破产:如何破局?降低医疗费用成为必然Hatch-Waxman法案出台美国FDA药品注册申请:新药(两类)、仿制药和非处方药申请1984年后NewDrugApplications(NDAs)AbbreviatedNewDrugApplications(ANDAs)“FullReports”ofSafetyandEfficacyInvestigationsApplicanthasrightofreferencetoessentialinvestigations?DuplicateofanalreadyapprovedproductNosafety/efficacydatapermitted(onlybioequivalence)YESNO505(b)(1)505(b)(2)505(j)NDA的研发和申报505(b)(1)新药申报资料内容IndexSummaryChemistry,ManufacturingandControlSamples,(foranti-microbialdrugsonly)(typicallysubmitted120daysaftertheNDA’ssubmission)(b)(2):历史过程HatchWaxman法案:1984ParkmanLetterPhantomANDAFDADraftGuidanceforIndustry(1999)FDAResponsetoCitizen’sPetition(2003)可以降低研发的费用和审评力量的浪费505(b)(2)的关键:可靠性Whatis“Reliance”Bywhom?Onwhat?&CdataFDAProcessforDeterminingRelianceWho,whenandhow?