中美仿制药研发和申报流程.ppt

文档介绍：中美仿制药研发和申报流程主要内容中美关于原研药和仿制药的背景2美国仿制药申报、基于问题的3我国仿制药申报、审评和研发4展望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)、panyLogo1984年后NewDrugApplicationsAbbreviatedNewDrug(NDASApplications(ANDAS“Fu∥Reports"ofsafetDuplicateofanalreadyandEfficacyInvestigationsapprovedproductApplicanthasrightofNosafety/efficacydatacetoessentialinvestigations?bioequivalence)505(b)(1)505(b)(2)505()ELERATEDDEVELOPMENT/REVIEWANIMALTESTINOIREATMENTIHORT-TERMFARALLONG-TERMTITUTIONALIEwBOARDSINDUSTRYTIMEINDSUBMITTEDNDASUBMITTEDREVIEW气SPONSORIFDAMEETINGSENCOURAGEI具匚csSPONSORAFROMREVIEw505)(1),(foranti-microbialdrugsonly)'(b)(2):历史过程HatchWaxman法案:(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sWhatisRelianceBywhom?OnWhat?RelianceandExclusivityMarketVSDataExclusivitySafety/EfficacyDataVsCM&cdataFDAProcessforDeterminingRelianceWhowhenandhow?