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    业内:国产仿制药质量比原研药相差远

    来源: 南方日报网络版     时间: 2020年02月26日 08:11:58
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    雷竞技官网手机版下载-雷竞技app最新版-雷竞技竞猜平台直招龙虎代理客服QQ/微信【421618535】诚招代理【在线开户网址um996.com】龙虎和龙虎1赔2.211合1赔9.95,定位胆1赔9.95腾讯分分彩,5分,10分彩,最高返水100反9快,最高赔率,正规信誉大平台平台24h提供注册及登录。业内:国产仿制药质量比原研药相差远

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    (  本)(刊)(记)(者)(孙)(爱)(民)(贺)(涛)(/文)(
      蓝)(色)(小)(药)(丸)(的)(价)(格)(依)(然)(坚)(挺)(。
      过)(去)(一)(年)(虽)(然)(是)(万)(艾)(可)(专)(利)(到)(期)(的)(第)(一)(年)(,但)(中)(国)(消)(费)(者)(并)(没)(有)(看)(到)(预)(期)(中)(的)(降)(价)(,100毫)(克)(一)(片)(装)(,售)(价)(还)(是)(128元)(。
      治)(疗)(男)(性)(性)(功)(能)(勃)(起)(障)(碍)((ED)、俗)(称)(“伟)(哥)(”的)(万)(艾)(可)(,由)(美)(国)(辉)(瑞)(公)(司)(研)(发)(,在)(华)(专)(利)(于)(2014年)(7月)(1日)(到)(期)(。此)(前)(医)(药)(界)(普)(遍)(认)(为)(,到)(期)(后)(它)(会)(降)(价)(,十)(余)(家)(中)(国)(药)(企)(也)(向)(药)(监)(部)(门)(申)(请)(仿)(制)(万)(艾)(可)(。
      仿)(制)(是)(制)(药)(产)(业)(中)(被)(允)(许)(的)(普)(遍)(做)(法)(。获)(得)(专)(利)(的)(药)(品)(被)(称)(为)(“原)(研)(药)(”,当)(专)(利)(到)(期)(后)(,其)(他)(药)(企)(可)(使)(用)(药)(物)(的)(化)(学)(合)(成)(物)(专)(利)(,自)(行)(开)(发)(配)(方)(工)(艺)(并)(合)(法)(生)(产)(仿)(制)(药)(。
      医)(学)(界)(的)(共)(识)(是)(,仿)(制)(药)(在)(剂)(型)(、规)(格)(、给)(药)(途)(径)(、质)(量)(以)(及)(药)(效)(和)(适)(应)(症)(方)(面)(,都)(应)(与)(原)(研)(药)(等)(同)(。
      在)(欧)(美)(市)(场)(,对)(于)(超)(过)(专)(利)(期)(的)(药)(品)(,迫)(于)(仿)(制)(药)(竞)(争)(压)(力)(,药)(厂)(多)(会)(主)(动)(降)(价)(,否)(则)(销)(量)(可)(能)(大)(幅)(下)(跌)(。万)(艾)(可)(在)(其)(他)(国)(家)(专)(利)(到)(期)(后)(,不)(乏)(降)(价)(先)(例)(。在)(泰)(国)(,万)(艾)(可)(降)(价)(约)(30%;澳)(大)(利)(亚)(每)(粒)(万)(艾)(可)(售)(价)(不)(到)(20元)(人)(民)(币)(。
      然)(而)(,艾)(美)(仕)(市)(场)(研)(究)(公)(司)(数)(据)(显)(示)(:2014年)(,万)(艾)(可)(在)(中)(国)(市)(场)(的)(销)(量)(不)(降)(反)(增)(,增)(幅)(达)(47%。数)(据)(显)(示)(,许)(多)(国)(外)(药)(品)(专)(利)(失)(效)(后)(,在)(中)(国)(市)(场)(仍)(维)(持)(原)(价)(,销)(量)(也)(未)(受)(影)(响)(。
      中)(国)(的)(化)(学)(药)(品)(市)(场)(多)(以)(仿)(制)(药)(为)(主)(,国)(内)(医)(药)(市)(场)(八)(成)(以)(上)(为)(仿)(制)(药)(。目)(前)(原)(料)(药)(和)(制)(剂)(生)(产)(企)(业)(约)(4800家)(,这)(些)(制)(药)(企)(业)(拥)(有)(化)(药)(品)(种)(批)(准)(文)(号)(10.5万)(个)(,绝)(大)(部)(分)(为)(仿)(制)(药)(,仿)(制)(药)(市)(场)(规)(模)(约)(为)(5000亿)(元)(。
      仿)(制)(药)(本)(以)(低)(价)(战)(略)(本)(可)(能)(在)(市)(场)(上)(大)(有)(斩)(获)(,却)(屡)(屡)(败)(于)(专)(利)(到)(期)(后)(的)(原)(研)(药)(,原)(因)(何)(在)(?
      药)(效)(差)(距)(的)(秘)(密)(
      在)(北)(京)(以)(打)(工)(为)(生)(的)(孙)(合)(林)(,近)(几)(日)(药)(箱)(告)(急)(。
      67岁)(的)(孙)(合)(林)(一)(个)(月)(前)(从)(老)(家)(山)(东)(到)(北)(京)(做)(木)(匠)(活)(,随)(身)(除)(了)(糊)(口)(的)(工)(具)(,还)(带)(着)(救)(急)(的)(降)(血)(糖)(药)(盐)(酸)(二)(甲)(双)(胍)(肠)(溶)(片)(。半)(年)(前)(他)(在)(家)(乡)(体)(检)(时)(查)(出)(2型)(糖)(尿)(病)(。
      药)(品)(是)(在)(一)(家)(县)(级)(人)(民)(医)(院)(开)(的)(。眼)(看)(药)(不)(够)(吃)(,孙)(合)(林)(在)(断)(药)(前)(一)(周)(拿)(着)(以)(前)(的)(药)(盒)(到)(药)(店)(买)(药)(。新)(药)(到)(手)(后)(,服)(用)(后)(孙)(却)(隐)(约)(觉)(得)(不)(对)(劲)(,血)(糖)(不)(降)(反)(升)(,心)(跳)(过)(快)(、呼)(吸)(不)(畅)(,高)(血)(糖)(的)(症)(状)(似)(乎)(重)(袭)(。
      孙)(合)(林)(怀)(疑)(买)(到)(假)(药)(,于)(是)(到)(附)(近)(的)(社)(区)(医)(院)(咨)(询)(,结)(果)(发)(现)(药)(品)(名)(字)(相)(同)(,但)(来)(自)(不)(同)(的)(生)(产)(厂)(家)(——同)(样)(是)(“盐)(酸)(二)(甲)(双)(胍)(肠)(溶)(片)(”,一)(个)(是)(河)(北)(一)(家)(药)(厂)(生)(产)(,另)(一)(个)(来)(自)(贵)(州)(一)(家)(药)(厂)(。
      国)(家)(食)(品)(药)(品)(监)(督)(管)(理)(总)(局)((下)(称)(食)(药)(监)(总)(局)()官)(方)(网)(站)(显)(示)(,这)(两)(种)(药)(都)(是)(真)(药)(,拥)(有)(相)(同)(的)(产)(品)(名)(称)(,只)(是)(生)(产)(厂)(家)(与)(商)(品)(名)(称)(不)(同)(。孙)(合)(林)(不)(明)(白)(,“一)(样)(的)(名)(字)(一)(样)(的)(药)(,为)(什)(么)(效)(果)(不)(一)(样)(?”
      同)(大)(部)(分)(患)(者)(一)(样)(,孙)(合)(林)(不)(了)(解)(中)(国)(制)(药)(界)(存)(在)(的)(一)(种)(公)(开)(的)(秘)(密)(:几)(十)(家)(甚)(至)(上)(百)(家)(药)(厂)(仿)(制)(、生)(产)(同)(一)(种)(药)(,药)(效)(却)(参)(差)(不)(齐)(。中)(国)(食)(品)(药)(品)(检)(定)(研)(究)(院)((下)(称)(中)(检)(院)()国)(际)(合)(作)(高)(级)(顾)(问)(金)(少)(鸿)(介)(绍)(,在)(治)(疗)(的)(关)(键)(时)(刻)(,不)(少)(医)(生)(倾)(向)(使)(用)(原)(研)(药)(,因)(为)(国)(产)(仿)(制)(药)(的)(质)(量)(与)(原)(研)(药)(存)(在)(差)(异)(。
      制)(药)(业)(内)(人)(士)(估)(计)(,70%以)(上)(的)(国)(产)(仿)(制)(药)(药)(效)(与)(原)(研)(药)(存)(在)(差)(距)(。食)(药)(监)(总)(局)(药)(品)(认)(证)(管)(理)(中)(心)(处)(长)(李)(正)(奇)(撰)(文)(称)(,国)(产)(仿)(制)(药)(总)(体)(质)(量)(比)(原)(研)(药)(相)(差)(远)(,有)(的)(甚)(至)(是)(安)(全)(的)(无)(效)(药)(。
      虽)(认)(为)(不)(能)(将)(所)(有)(仿)(制)(药)(药)(企)(一)(棍)(子)(打)(死)(,但)(齐)(鲁)(制)(药)(集)(团)(药)(物)(研)(究)(院)(院)(长)(张)(明)(会)(、绿)(叶)(制)(药)(集)(团)(法)(规)(与)(注)(册)(部)(总)(监)(由)(春)(娜)(在)(接)(受)(《财)(经)(》记)(者)(采)(访)(时)(也)(分)(别)(承)(认)(,国)(内)(部)(分)(仿)(制)(药)(存)(在)(研)(究)(不)(透)(彻)(、质)(量)(控)(制)(不)(严)(格)(以)(致)(药)(效)(不)(足)(的)(情)(况)(。
      仿)(制)(药)(与)(原)(研)(药)(的)(有)(效)(化)(学)(成)(分)(应)(该)(是)(一)(样)(的)(。原)(研)(药)(专)(利)(到)(期)(后)(,有)(效)(成)(分)(的)(分)(子)(结)(构)(、剂)(量)(和)(理)(化)(特)(性)(都)(会)(公)(开)(。比)(如)(,“伟)(哥)(”的)(有)(效)(成)(分)(细)(节)(甚)(至)(在)(百)(度)(百)(科)(都)(能)(查)(到)(。
      但)(是)(,使)(这)(些)(有)(效)(成)(分)(能)(成)(功)(地)(按)(时)(在)(人)(体)(内)(释)(放)(,才)(是)(药)(品)(发)(挥)(药)(效)(的)(关)(键)(。一)(粒)(药)(,在)(经)(过)(患)(者)(的)(消)(化)(系)(统)(时)(,需)(在)(适)(当)(时)(间)(崩)(解)(、溶)(化)(,释)(放)(出)(有)(效)(成)(分)(,被)(胃)(肠)(道)(吸)(收)(。
      这)(个)(过)(程)(很)(有)(讲)(究)(:如)(果)(过)(速)(,可)(能)(导)(致)(有)(效)(成)(分)(吸)(收)(太)(快)(,血)(清)(浓)(度)(峰)(值)(过)(高)(,带)(来)(副)(作)(用)(,且)(药)(效)(不)(够)(持)(久)(;如)(果)(欠)(速)(,有)(效)(成)(分)(就)(可)(能)(来)(不)(及)(完)(全)(溶)(出)(就)(被)(排)(出)(,药)(效)(则)(发)(挥)(不)(出)(。
      这)(个)(过)(程)(就)(要)(依)(靠)(药)(品)(使)(用)(的)(辅)(料)(与)(制)(作)(工)(艺)(,这)(是)(药)(企)(研)(发)(极)(为)(核)(心)(的)(资)(产)(。
      以)(德)(国)(拜)(耳)(公)(司)(生)(产)(的)(阿)(司)(匹)(林)(肠)(溶)(片)(为)(例)(,拜)(耳)(拥)(有)(独)(到)(的)(制)(剂)(技)(术)(,它)(可)(以)(使)(药)(品)(在)(专)(利)(过)(期)(后)(依)(然)(规)(避)(挑)(战)(,因)(为)(国)(内)(仿)(制)(药)(无)(法)(在)(工)(艺)(上)(实)(现)(使)(药)(品)(只)(在)(肠)(道)(溶)(解)(。
      “原)(研)(药)(厂)(商)(,一)(般)(拥)(有)(多)(个)(工)(艺)(配)(方)(的)(专)(利)(。”中)(国)(医)(药)(质)(量)(管)(理)(协)(会)(副)(会)(长)(孙)(新)(生)(对)(《财)(经)(》记)(者)(介)(绍)(,新)(药)(的)(专)(利)(期)(限)(是)(20年)(,而)(药)(企)(在)(化)(合)(物)(、原)(料)(药)(专)(利)(到)(期)(后)(,还)(拥)(有)(数)(年)(后)(才)(会)(到)(期)(的)(工)(艺)(配)(方)(专)(利)(,此)(举)(可)(使)(专)(利)(药)(的)(利)(用)(期)(限)(相)(应)(延)(长)(。
      另)(外)(,药)(品)(的)(辅)(料)(更)(扮)(演)(着)(关)(键)(性)(角)(色)(。辅)(料)(,大)(部)(分)(是)(高)(分)(子)(材)(料)(,有)(一)(定)(分)(子)(量)(分)(布)(,而)(非)(单)(一)(成)(分)(,这)(意)(味)(着)(很)(难)(使)(用)(简)(单)(的)(含)(量)(指)(标)(检)(测)(它)(。因)(此)(,同)(一)(名)(称)(辅)(料)(,如)(果)(由)(不)(同)(企)(业)(生)(产)(,产)(品)(差)(别)(可)(能)(很)(大)(。有)(一)(些)(辅)(料)(品)(种)(,如)(出)(现)(一)(种)(或)(几)(种)(特)(定)(杂)(质)(,其)(在)(使)(用)(环)(境)(下)(就)(会)(产)(生)(不)(确)(定)(的)(药)(理)(作)(用)(,从)(而)(带)(来)(安)(全)(隐)(患)(。
      美)(国)(食)(品)(药)(品)(监)(督)(管)(理)(局)((FDA)规)(定)(,仿)(制)(药)(审)(批)(时)(,也)(需)(申)(报)(药)(品)(所)(使)(用)(的)(辅)(料)(,及)(辅)(料)(生)(产)(企)(业)(的)(生)(产)(规)(范)(证)(书)((GMP)和)(检)(验)(报)(告)((COA),提)(供)(分)(析)(数)(据)(。
      但)(中)(国)(对)(辅)(料)(的)(监)(管)(尚)(不)(严)(格)(。2006年)(出)(台)(的)(《药)(用)(辅)(料)(生)(产)(质)(量)(管)(理)(规)(范)(》中)(,没)(有)(实)(行)(强)(制)(认)(证)(。
      一)(位)(浙)(江)(药)(企)(研)(发)(主)(管)(告)(诉)(《财)(经)(》记)(者)(,有)(的)(药)(企)(为)(节)(省)(成)(本)(,在)(药)(品)(审)(批)(环)(节)(,向)(监)(管)(部)(门)(申)(报)(质)(量)(较)(高)(的)(辅)(料)(厂)(商)(,进)(入)(生)(产)(环)(节)(时)(,就)(更)(换)(为)(廉)(价)(、质)(量)(次)(等)(的)(厂)(商)(。而)(在)(药)(品)(制)(成)(甚)(至)(上)(市)(前)(后)(,通)(常)(不)(会)(被)(要)(求)(再)(次)(检)(验)(。
      中)(国)(是)(原)(料)(药)(的)(生)(产)(与)(出)(口)(大)(国)(,但)(是)(辅)(料)(的)(研)(发)(严)(重)(不)(足)(,新)(型)(药)(用)(辅)(料)(几)(乎)(全)(部)(依)(赖)(进)(口)(。
      张)(明)(会)(告)(诉)(《财)(经)(》记)(者)(,国)(内)(不)(少)(仿)(制)(药)(药)(企)(使)(用)(与)(原)(研)(药)(不)(同)(的)(辅)(料)(进)(行)(生)(产)(,这)(是)(导)(致)(仿)(制)(药)(与)(原)(研)(药)(药)(效)(差)(异)(的)(原)(因)(之)(一)(。
      2014年)(9月)(轰)(动)(一)(时)(的)(“毒)(胶)(囊)(”事)(件)(就)(事)(发)(于)(辅)(料)(。案)(中)(,浙)(江)(一)(家)(药)(用)(辅)(料)(企)(业)(用)(工)(业)(明)(胶)(生)(产)(药)(用)(胶)(囊)(,进)(入)(制)(药)(企)(业)(,导)(致)(9000万)(粒)(铬)(超)(标)(毒)(胶)(囊)(流)(入)(市)(场)(。
      “毒)(胶)(囊)(”事)(件)(是)(辅)(料)(管)(控)(不)(严)(的)(极)(端)(事)(件)(。绝)(大)(多)(数)(由)(于)(工)(艺)(和)(辅)(料)(导)(致)(药)(效)(不)(足)(的)(仿)(制)(药)(,在)(生)(产)(与)(流)(通)(环)(节)(是)(低)(效)(药)(或)(者)(无)(效)(药)(。虽)(然)(这)(种)(药)(不)(致)(产)(生)(危)(害)(,但)(药)(效)(不)(够)(,既)(耽)(误)(治)(疗)(时)(机)(,也)(有)(可)(能)(延)(长)(患)(者)(的)(痛)(苦)(、病)(程)(。
      比)(如)(,精)(神)(障)(碍)(疾)(病)(患)(者)(需)(要)(定)(期)(服)(用)(氯)(氮)(平)(,以)(使)(病)(情)(稳)(定)(在)(可)(控)(范)(围)(内)(,配)(合)(其)(他)(治)(疗)(方)(法)(实)(行)(诊)(治)(。氯)(氮)(平)(本)(身)(具)(有)(副)(作)(用)(,患)(者)(服)(用)(后)(会)(出)(现)(白)(血)(球)(降)(低)(的)(症)(状)(。一)(位)(制)(药)(业)(资)(深)(人)(士)(向)(《财)(经)(》记)(者)(透)(露)(,他)(们)(在)(研)(究)(中)(发)(现)(,服)(用)(国)(产)(氯)(氮)(平)(的)(患)(者)(中)(,很)(少)(出)(现)(白)(血)(球)(减)(少)(的)(情)(况)(,这)(说)(明)(该)(药)(的)(药)(效)(是)(不)(足)(的)(。精)(神)(障)(碍)(疾)(病)(患)(者)(如)(果)(不)(能)(得)(到)(有)(效)(药)(物)(的)(帮)(助)(,有)(些)(人)(会)(产)(生)(暴)(力)(攻)(击)(倾)(向)(,甚)(至)(有)(自)(杀)(行)(为)(。
      绿)(叶)(制)(药)(集)(团)(法)(规)(与)(注)(册)(部)(总)(监)(由)(春)(娜)(告)(诉)(《财)(经)(》记)(者)(,对)(于)(治)(疗)(时)(间)(窗)(口)(宽)(的)(药)(品)(,如)(果)(药)(品)(本)(身)(药)(效)(不)(足)(,患)(者)(只)(要)(多)(服)(用)(一)(些)(就)(可)(以)(,对)(病)(情)(本)(身)(不)(会)(有)(多)(大)(影)(响)(,但)(针)(对)(一)(些)(特)(殊)(的)(病)(情)(,药)(效)(直)(接)(关)(系)(到)(病)(情)(的)(控)(制)(。
      审)(评)(标)(准)(的)(欠)(账)(
      仿)(制)(药)(中)(不)(少)(药)(效)(不)(佳)(这)(一)(事)(实)(,已)(被)(监)(管)(部)(门)(、相)(关)(行)(业)(协)(会)(和)(多)(数)(制)(药)(企)(业)(承)(认)(。作)(为)(控)(制)(药)(品)(上)(市)(的)(门)(槛)(,药)(品)(的)(审)(评)(标)(准)(过)(低)(,当)(负)(首)(要)(责)(任)(。
      2000年)(以)(前)(,国)(内)(药)(界)(首)(要)(解)(决)(的)(问)(题)(是)(药)(品)(紧)(缺)(性)(,仿)(制)(药)(审)(批)(权)(掌)(握)(在)(各)(省)(卫)(生)(部)(门)(手)(中)(,此)(一)(“草)(莽)(时)(期)(”,仿)(制)(药)(获)(批)(相)(对)(容)(易)(。
      涉)(及)(仿)(制)(药)(安)(全)(和)(有)(效)(性)(的)(审)(评)(标)(准)(过)(低)(,导)(致)(大)(批)(本)(来)(不)(具)(备)(生)(产)(仿)(制)(药)(能)(力)(和)(资)(质)(的)(企)(业)(也)(轻)(易)(拿)(到)(药)(品)(批)(号)(。在)(药)(品)(审)(批)(最)(疯)(狂)(的)(2005年)(,超)(过)(10000种)(药)(品)(通)(过)(审)(批)(上)(市)(,2006年)(达)(到)(顶)(峰)(。而)(这)(一)(时)(期)(的)(药)(品)(仍)(然)(是)(目)(前)(中)(国)(药)(品)(市)(场)(的)(主)(力)(。
      北)(京)(一)(家)(药)(企)(研)(发)(负)(责)(人)(披)(露)(,他)(在)(2001年)(攻)(读)(博)(士)(学)(位)(期)(间)(,曾)(与)(两)(名)(合)(作)(者)(一)(夜)(之)(间)(通)(过)(文)(献)(拼)(凑)(,完)(成)(一)(种)(仿)(制)(药)(“研)(发)(”,后)(来)(将)(该)(药)(卖)(给)(一)(家)(药)(企)(并)(通)(过)(审)(批)(,至)(今)(还)(在)(生)(产)(、流)(通)(。
      2007年)(《药)(品)(注)(册)(管)(理)(办)(法)(》修)(订)(,在)(一)(定)(程)(度)(上)(规)(范)(了)(仿)(制)(药)(的)(审)(批)(程)(序)(。不)(过)(,标)(准)(过)(低)(的)(问)(题)(仍)(未)(彻)(底)(解)(决)(。比)(如)(,是)(否)(选)(择)(原)(研)(药)(作)(为)(仿)(制)(对)(象)(决)(定)(了)(仿)(制)(药)(的)(药)(效)(,可)(是)(该)(办)(法)(允)(许)(在)(无)(法)(获)(得)(原)(研)(药)(时)(,可)(选)(用)(已)(上)(市)(的)(国)(产)(仿)(制)(药)(作)(为)(参)(照)(物)(再)(仿)(制)(。
      拿)(仿)(制)(药)(作)(为)(仿)(制)(标)(准)(,很)(容)(易)(导)(致)(“越)(仿)(越)(不)(像)(”。孙)(新)(生)(称)(,药)(品)(仿)(制)(本)(难)(以)(达)(到)(与)(原)(研)(药)(100%一)(致)(,每)(一)(次)(仿)(制)(可)(能)(带)(来)(20%的)(误)(差)(累)(积)(,如)(果)(越)(仿)(越)(低)(,与)(原)(研)(药)(药)(效)(就)(相)(去)(越)(远)(。
      《药)(品)(注)(册)(管)(理)(办)(法)(》允)(许)(拿)(仿)(制)(药)(做)(标)(杆)(,一)(定)(程)(度)(上)(是)(出)(于)(无)(奈)(。早)(期)(,进)(口)(药)(品)(难)(以)(获)(得)(,缺)(少)(获)(得)(原)(研)(药)(的)(合)(法)(途)(径)(,情)(非)(得)(已)(之)(下)(,只)(好)(允)(许)(药)(企)(以)(仿)(制)(药)(作)(为)(仿)(制)(标)(准)(。
      但)(这)(一)(漏)(洞)(被)(众)(多)(药)(企)(利)(用)(。食)(药)(监)(总)(局)(药)(品)(审)(评)(中)(心)(特)(聘)(专)(家)(程)(鲁)(榕)(透)(露)(,像)(卡)(维)(地)(洛)(片)(、马)(来)(酸)(依)(那)(普)(利)(片)(等)(制)(剂)(,国)(内)(市)(场)(已)(有)(原)(研)(药)(,一)(些)(申)(报)(机)(构)(提)(交)(的)(试)(验)(却)(并)(未)(选)(用)(。
      FDA专)(门)(出)(版)(了)(一)(本)(“橙)(皮)(书)(”作)(为)(“金)(标)(准)(”,录)(入)(所)(有)(专)(利)(到)(期)(的)(原)(研)(药)(,规)(定)(仿)(制)(企)(业)(必)(须)(从)(中)(选)(择)(仿)(制)(对)(象)(。中)(国)(还)(没)(有)(类)(似)(的)(“金)(标)(准)(”。
      对)(于)(仿)(制)(药)(药)(效)(的)(判)(断)(也)(出)(现)(歧)(路)(。
      判)(断)(仿)(制)(药)(与)(原)(研)(药)(药)(效)(是)(否)(一)(致)(,中)(国)(监)(管)(部)(门)(的)(主)(要)(依)(据)(是)(体)(外)(溶)(出)(曲)(线)(,如)(果)(仿)(制)(药)(体)(外)(多)(条)(溶)(出)(曲)(线)(均)(与)(原)(研)(药)(一)(致)(,则)(两)(者)(生)(物)(利)(用)(度)(一)(致)(的)(概)(率)(达)(90%。
      体)(外)(溶)(出)(曲)(线)(的)(试)(验)(方)(法)(是)(,在)(容)(器)(中)(模)(拟)(出)(人)(的)(肠)(胃)(环)(境)(,然)(后)(投)(入)(药)(品)(,测)(量)(溶)(出)(曲)(线)(,这)(条)(标)(准)(可)(以)(使)(大)(量)(仿)(制)(药)(现)(出)(原)(形)(。
      据)(《中)(国)(医)(药)(报)(》报)(道)(,2008年)(国)(家)(评)(价)(性)(抽)(验)(中)(,发)(现)(按)(照)(当)(时)(的)(质)(量)(标)(准)(,首)(检)(仿)(制)(药)(几)(乎)(100%合)(格)(,然)(而)(没)(有)(一)(个)(仿)(制)(药)(品)(的)(体)(外)(溶)(出)(度)(曲)(线)(与)(被)(仿)(制)(药)(品)(一)(致)(,且)(相)(当)(一)(部)(分)(药)(品)(溶)(出)(曲)(线)(与)(原)(研)(药)(相)(差)(甚)(远)(。
      孙)(合)(林)(的)(盐)(酸)(二)(甲)(双)(胍)(肠)(溶)(片)(,国)(内)(多)(家)(药)(厂)(生)(产)(,商)(品)(名)(称)(甚)(至)(都)(不)(一)(样)(。温)(州)(医)(学)(院)(附)(属)(第)(一)(医)(院)(药)(剂)(科)(主)(任)(药)(师)(张)(秀)(华)(对)(市)(面)(上)(常)(见)(的)(盐)(酸)(二)(甲)(双)(胍)(进)(行)(了)(对)(比)(研)(究)(,结)(果)(发)(现)(,6个)(厂)(家)(生)(产)(的)(普)(通)(片)(和)(4个)(厂)(家)(生)(产)(的)(缓)(释)(片)(含)(量)(均)(符)(合)(药)(典)(规)(定)(,但)(溶)(出)(参)(数)(差)(异)(明)(显)(。
      严)(格)(的)(把)(关)(标)(准)(是)(将)(“生)(物)(等)(效)(性)(试)(验)(”作)(为)(必)(要)(指)(标)(,即)(需)(比)(对)(仿)(制)(药)(和)(原)(研)(药)(在)(人)(体)(内)(药)(物)(有)(效)(成)(分)(总)(体)(吸)(收)(程)(度)(和)(血)(液)(中)(能)(达)(到)(的)(最)(高)(药)(物)(浓)(度)(。这)(一)(实)(验)(被)(写)(入)(美)(国)(的)(“Hatch-Waxman”法)(案)(。
      中)(国)(《仿)(制)(药)(品)(审)(批)(办)(法)(》也)(规)(定)(,申)(报)(药)(企)(需)(在)(第)(三)(方)(临)(床)(研)(究)(机)(构)(进)(行)(生)(物)(等)(效)(性)(试)(验)(。但)(这)(一)(事)(关)(仿)(制)(药)(生)(死)(的)(试)(验)(,却)(未)(被)(认)(真)(执)(行)(。
      调)(查)(显)(示)(,同)(一)(款)(仿)(制)(药)(送)(到)(国)(内)(不)(同)(实)(验)(室)(做)(生)(物)(等)(效)(性)(试)(验)(,参)(数)(可)(能)(会)(相)(差)(17倍)(,同)(一)(实)(验)(室)(之)(间)(的)(参)(数)(也)(可)(能)(相)(差)(3倍)(-4倍)(。
      一)(位)(药)(业)(资)(深)(人)(士)(分)(析)(,数)(量)(众)(多)(的)(小)(药)(企)(为)(了)(得)(到)(药)(品)(批)(号)(,铤)(而)(走)(险)(,与)(第)(三)(方)(试)(验)(机)(构)(勾)(兑)(,修)(改)(试)(验)(数)(据)(。
      一)(场)(生)(物)(等)(效)(性)(试)(验)(的)(费)(用)(为)(30万)(元)(到)(60万)(元)(,对)(一)(些)(小)(医)(院)(来)(说)(,可)(能)(向)(药)(厂)(妥)(协)(,在)(数)(据)(上)(做)(手)(脚)(,甚)(至)(连)(试)(验)(对)(象)(的)(人)(数)(都)(不)(足)(。
      企)(业)(上)(报)(药)(品)(审)(评)(部)(门)(的)(往)(往)(是)(好)(看)(的)(数)(据)(,因)(此)(,“生)(物)(等)(效)(性)(实)(验)(从)(没)(听)(说)(失)(败)(的)(,公)(开)(报)(道)(都)(是)(一)(次)(性)(成)(功)(”。上)(海)(市)(食)(品)(药)(品)(检)(验)(所)(副)(主)(任)(药)(师)(谢)(沐)(风)(告)(诉)(《财)(经)(》记)(者)(,由)(于)(在)(法)(规)(上)(信)(任)(第)(三)(方)(生)(物)(等)(效)(性)(试)(验)(结)(果)(,监)(管)(部)(门)(一)(般)(也)(不)(会)(进)(行)(复)(查)(审)(核)(。
      如)(果)(上)(市)(与)(监)(管)(的)(标)(准)(低)(,大)(部)(分)(企)(业)(自)(然)(会)(依)(照)(最)(低)(标)(准)(实)(行)(生)(产)(,能)(减)(的)(成)(本)(尽)(量)(砍)(掉)(。谢)(沐)(风)(说)(:“要)(求)(20分)(可)(以)(及)(格)(,企)(业)(一)(般)(认)(为)(做)(到)(21分)(就)(可)(以)(了)(,做)(多)(了)(就)(觉)(得)(是)(浪)(费)(。”
      药)(企)(前)(路)(
      对)(中)(国)(仿)(制)(药)(药)(企)(而)(言)(,决)(定)(其)(生)(存)(的)(因)(素)(很)(大)(程)(度)(并)(非)(是)(药)(品)(药)(效)(,而)(仰)(仗)(于)(与)(医)(院)(的)(关)(系)(。不)(过)(,一)(旦)(药)(效)(被)(提)(上)(监)(管)(日)(程)(,也)(意)(味)(着)(淘)(汰)(低)(端)(仿)(制)(的)(生)(死)(关)(头)(来)(临)(。
      事)(实)(上)(,对)(各)(国)(而)(言)(,仿)(制)(药)(皆)(不)(可)(或)(缺)(。美)(国)(仿)(制)(药)(协)(会)((TheGenericPharmaceuticalAssociation)报)(告)(显)(示)(,2013年)(仿)(制)(药)(为)(美)(国)(健)(康)(系)(统)(节)(约)(高)(达)(2390亿)(美)(元)(的)(经)(费)(,这)(一)(数)(据)(尚)(未)(将)(品)(牌)(药)(品)(公)(司)(面)(临)(仿)(制)(药)(竞)(争)(时)(打)(折)(等)(可)(能)(发)(生)(的)(费)(用)(下)(降)(考)(虑)(在)(内)(。
      从)(公)(共)(政)(策)(角)(度)(看)(,仿)(制)(药)(可)(以)(让)(国)(人)(得)(到)(相)(对)(便)(宜)(的)(药)(品)(,降)(低)(医)(保)(支)(出)(。
      不)(过)(,艾)(美)(仕)(市)(场)(研)(究)(公)(司)(特)(约)(评)(论)(员)(文)(章)(称)(,按)(照)(国)(际)(市)(场)(的)(经)(验)(,仿)(制)(药)(的)(价)(格)(再)(低)(,也)(会)(保)(持)(在)(原)(研)(药)(价)(格)(30%左)(右)(。
      遗)(憾)(的)(是)(,目)(前)(中)(国)(仿)(制)(药)(的)(价)(格)(只)(有)(原)(研)(药)(的)(10%。超)(低)(价)(格)(使)(企)(业)(不)(得)(不)(在)(质)(量)(上)(妥)(协)(。
      压)(缩)(中)(国)(药)(企)(利)(润)(的)(是)(手)(握)(用)(药)(权)(的)(医)(院)(。上)(述)(制)(药)(业)(资)(深)(人)(士)(表)(示)(,在)(药)(品)(的)(流)(通)(环)(节)(,医)(院)(处)(于)(强)(势)(地)(位)(,药)(企)(根)(本)(没)(有)(议)(价)(权)(,“中)(国)(药)(企)(的)(平)(均)(利)(润)(连)(15%都)(没)(有)(”。
      研)(发)(一)(个)(仿)(制)(药)(品)(种)(,花)(费)(一)(般)(在)(50万)(-200万)(元)(,再)(加)(上)(生)(物)(等)(效)(的)(临)(床)(试)(验)(投)(入)(约)(50万)(-100万)(元)(;除)(这)(些)(成)(本)(,出)(厂)(价)(中)(还)(要)(加)(上)(审)(评)(的)(公)(关)(费)(用)(。
      出)(厂)(价)(区)(区)(几)(元)(,到)(患)(者)(手)(中)(或)(为)(数)(十)(元)(的)(药)(品)(,除)(17%税)(费)(,还)(包)(括)(配)(送)(公)(司)(6个)(-8个)(点)(的)(配)(送)(费)(,代)(理)(商)(30个)(点)(的)(费)(用)(,公)(关)(费)(约)(20%的)(费)(用)(,其)(主)(要)(用)(于)(打)(通)(医)(院)(的)(关)(节)(。这)(样)(药)(企)(不)(在)(质)(量)(上)(克)(扣)(很)(难)(获)(得)(预)(期)(利)(润)(。
      此)(外)(,一)(个)(药)(品)(往)(往)(面)(临)(几)(十)(上)(百)(家)(仿)(制)(,这)(使)(国)(产)(仿)(制)(药)(恶)(性)(价)(格)(战)(频)(起)(,也)(进)(一)(步)(挤)(压)(了)(利)(润)(空)(间)(。
      2015年)(7月)(11日)(,食)(药)(监)(总)(局)(局)(长)(毕)(井)(泉)(公)(开)(表)(示)(,忽)(视)(质)(量)(疗)(效)(盲)(目)(追)(求)(低)(成)(本)(、低)(价)(格)(,只)(能)(诱)(导)(企)(业)(购)(买)(最)(便)(宜)(的)(原)(辅)(料)(、按)(最)(低)(的)(标)(准)(投)(料)(生)(产)(药)(品)(,其)(极)(有)(可)(能)(是)(安)(全)(无)(效)(的)(劣)(药)(,甚)(至)(假)(药)(。
      价)(格)(战)(也)(集)(中)(体)(现)(在)(仿)(制)(药)(业)(的)(产)(业)(集)(中)(度)(低)(下)(。FDA针)(对)(美)(国)(在)(1999年)(—2004年)(中)(仿)(制)(药)(的)(价)(格)(与)(生)(产)(厂)(家)(之)(间)(的)(数)(量)(关)(系)(做)(过)(统)(计)(,结)(果)(显)(示)(,当)(仿)(制)(药)(厂)(家)(只)(有)(两)(家)(时)(,仿)(制)(药)(价)(格)(为)(原)(研)(药)(的)(52%;当)(生)(产)(厂)(家)(数)(目)(增)(至)(10家)(时)(,其)(价)(格)(降)(至)(原)(研)(药)(的)(26%;当)(生)(产)(厂)(家)(数)(目)(接)(近)(20家)(时)(,仿)(制)(药)(的)(价)(格)(仅)(为)(原)(研)(药)(的)(6%。
      为)(了)(扭)(转)(诸)(多)(弊)(端)(,政)(府)(频)(频)(释)(放)(将)(对)(优)(质)(仿)(制)(药)(给)(予)(政)(策)(优)(惠)(的)(信)(号)(。国)(务)(院)(在)(《关)(于)(改)(革)(药)(品)(医)(疗)(器)(械)(审)(评)(审)(批)(制)(度)(的)(意)(见)(》中)(承)(诺)(,“通)(过)(质)(量)(一)(致)(性)(评)(价)(的)(,允)(许)(其)(在)(说)(明)(书)(和)(标)(签)(上)(予)(以)(标)(注)(,并)(在)(临)(床)(应)(用)(、招)(标)(采)(购)(、医)(保)(报)(销)(等)(方)(面)(给)(予)(支)(持)(。”
      按)(毕)(井)(泉)(的)(表)(述)(,未)(来)(对)(于)(与)(原)(研)(药)(疗)(效)(一)(致)(的)(药)(品)(,食)(药)(监)(总)(局)(会)(允)(许)(企)(业)(在)(药)(品)(外)(包)(装)(上)(印)(出)(明)(显)(标)(识)(,以)(便)(医)(生)(和)(患)(者)(识)(别)(选)(择)(。
      食)(药)(监)(总)(局)(副)(局)(长)(吴)(浈)(认)(为)(,质)(量)(提)(升)(以)(后)(的)(产)(品)(,价)(格)(肯)(定)(会)(提)(高)(,按)(照)(高)(标)(准)(生)(产)(,自)(然)(会)(抬)(高)(仿)(制)(药)(成)(本)(,“低)(价)(格)(就)(没)(有)(好)(药)(”。
      有)(些)(药)(商)(已)(经)(有)(不)(如)(归)(去)(之)(感)(慨)(。“只)(做)(仿)(制)(药)(是)(没)(有)(前)(途)(的)(。”一)(家)(药)(企)(研)(发)(负)(责)(人)(五)(年)(前)(转)(战)(新)(药)(研)(发)(,现)(已)(有)(两)(个)(新)(药)(在)(审)(评)(名)(单)(中)(排)(队)(,他)(相)(信)(仿)(制)(药)(的)(发)(展)(潜)(力)(有)(限)(。
      迫)(于)(转)(型)(攻)(坚)(期)(压)(力)(,不)(少)(药)(企)(独)(辟)(蹊)(径)(,通)(过)(OEM贴)(牌)(或)(者)(自)(主)(品)(牌)(的)(方)(式)(把)(国)(产)(高)(质)(量)(仿)(制)(药)(打)(入)(了)(欧)(美)(等)(发)(达)(国)(家)(市)(场)(。这)(种)(类)(似)(于)(电)(子)(产)(品)(行)(业)(的)(代)(工)(生)(产)(能)(否)(为)(这)(些)(药)(企)(谋)(得)(生)(路)(,还)(有)(待)(观)(察)(。
      改)(革)(阻)(力)(重)(重)(
      当)(经)(济)(体)(量)(和)(民)(生)(需)(求)(发)(展)(到)(一)(定)(阶)(段)(,变)(革)(必)(然)(产)(生)(。1962年)(美)(国)(国)(会)(通)(过)(药)(品)(修)(正)(案)(,首)(次)(提)(出)(药)(品)(不)(仅)(要)(“安)(全)(”,还)(必)(须)(“有)(效)(”。如)(今)(,中)(国)(正)(经)(历)(这)(一)(痛)(苦)(过)(程)(。
      上)(世)(纪)(末)(,中)(国)(开)(展)(对)(药)(品)(研)(究)(、生)(产)(、流)(通)(等)(环)(节)(实)(行)(质)(量)(管)(理)(规)(范)(的)(认)(证)(制)(度)(,从)(药)(品)(生)(产)(全)(过)(程)(加)(强)(药)(品)(质)(量)(安)(全)(控)(制)(。在)(那)(一)(轮)(整)(治)(中)(,药)(品)(审)(批)(实)(现)(地)(标)(升)(国)(标)(,药)(品)(生)(产)(企)(业)(实)(现)(GMP认)(证)(,药)(企)(由)(原)(来)(的)(7000多)(家)(缩)(减)(到)(4000多)(家)(。这)(些)(措)(施)(使)(仿)(制)(药)(的)(研)(制)(水)(平)(、质)(量)(和)(安)(全)(性)(显)(著)(提)(升)(。
      安)(全)(性)(基)(本)(保)(障)(后)(,有)(效)(性)(开)(始)(得)(到)(监)(管)(部)(门)(与)(社)(会)(舆)(论)(的)(关)(注)(,这)(是)(近)(几)(年)(的)(趋)(势)(。
      2006年)(,钟)(南)(山)(院)(士)(在)(“两)(会)(”期)(间)(向)(药)(监)(部)(门)(发)(难)(,质)(问)(为)(何)(一)(时)(间)(出)(现)(如)(此)(多)(药)(号)(。此)(后)(,药)(监)(部)(门)(再)(度)(展)(开)(对)(药)(品)(行)(业)(的)(整)(顿)(,虽)(然)(淘)(汰)(了)(一)(些)(企)(业)(与)(药)(品)(,但)(整)(顿)(仍)(局)(限)(于)(质)(量)(控)(制)(。
      自)(2007年)(以)(后)(,食)(药)(监)(总)(局)(收)(紧)(了)(仿)(制)(药)(的)(审)(批)(标)(准)(,新)(增)(仿)(制)(药)(的)(质)(量)(得)(以)(提)(升)(,但)(数)(量)(庞)(大)(的)(历)(史)(欠)(账)(,仍)(将)(仿)(制)(药)(的)(整)(体)(质)(量)(拖)(累)(在)(较)(低)(水)(平)(。
      从)(2009年)(开)(始)(,国)(仿)(药)(的)(药)(效)(问)(题)(逐)(渐)(成)(为)(关)(注)(焦)(点)(。由)(春)(娜)(分)(析)(,媒)(体)(报)(道)(借)(助)(个)(别)(案)(例)(,将)(部)(分)(药)(品)(存)(在)(的)(问)(题)(上)(升)(为)(对)(整)(个)(行)(业)(的)(拷)(问)(,助)(推)(了)(监)(管)(部)(门)(整)(治)(的)(决)(心)(。
      为)(将)(药)(效)(欠)(佳)(的)(仿)(制)(药)(驱)(逐)(出)(市)(场)(,国)(务)(院)(在)(《国)(家)(药)(品)(安)(全)(“十)(二)(五)(”规)(划)(》中)(提)(出)(,对)(2007年)(前)(批)(准)(的)(仿)(制)(药)(,分)(期)(分)(批)(与)(被)(仿)(制)(药)(进)(行)(质)(量)(一)(致)(性)(评)(价)(,未)(通)(过)(评)(价)(的)(仿)(制)(药)(将)(被)(注)(销)(。食)(药)(监)(总)(局)(成)(立)(仿)(制)(药)(质)(量)(一)(致)(性)(评)(价)(工)(作)(办)(公)(室)((下)(称)(评)(价)(办)(公)(室)(),负)(责)(具)(体)(实)(施)(上)(述)(规)(划)(。
      据)(了)(解)(,其)(工)(作)(流)(程)(自)(下)(而)(上)(进)(行)(,先)(由)(评)(价)(办)(公)(室)(确)(定)(评)(价)(方)(法)(、标)(准)(等)(,省)(级)(药)(监)(部)(门)(负)(责)(资)(料)(受)(理)(、生)(产)(现)(场)(检)(查)(和)(抽)(样)(检)(验)(,评)(价)(办)(公)(室)(组)(织)(专)(家)(委)(员)(复)(查)(。
      然)(而)(,部)(门)(间)(既)(得)(利)(益)(者)(的)(博)(弈)(,使)(实)(质)(进)(展)(缓)(慢)(。评)(价)(办)(公)(室)(前)(期)(目)(标)(是)(完)(成)(75个)(基)(药)(品)(种)(,中)(检)(院)(至)(2015年)(4月)(20日)(初)(步)(完)(成)(34个)(品)(种)(的)(方)(法)(研)(究)(,经)(专)(家)(审)(核)(通)(过)(9个)(品)(种)(的)(评)(价)(方)(法)(,41个)(品)(种)(正)(处)(于)(方)(法)(研)(究)(阶)(段)(。这)(些)(工)(作)(按)(计)(划)(,本)(应)(在)(2013年)(至)(2014年)(完)(成)(。
      按)(“十)(二)(五)(”规)(划)(,570种)(纳)(入)(国)(家)(基)(本)(药)(物)(目)(录)(和)(临)(床)(常)(用)(的)(化)(学)(药)(在)(2015年)(前)(完)(成)(。570种)(常)(用)(药)(品)(涉)(及)(2400家)(企)(业)(,3.3万)(个)(批)(号)(。
      业)(界)(的)(共)(识)(是)(,2015年)(的)(目)(标)(根)(本)(无)(法)(按)(时)(完)(成)(。
      从)(技)(术)(上)(分)(析)(,仿)(制)(药)(一)(致)(性)(评)(价)(不)(存)(在)(难)(题)(。“日)(本)(已)(实)(行)(18年)(,技)(术)(很)(成)(熟)(,问)(题)(在)(于)(决)(策)(者)(能)(否)(下)(定)(决)(心)(。”一)(位)(地)(方)(仪)(器)(药)(品)(检)(验)(所)(官)(员)(对)(《财)(经)(》记)(者)(表)(示)(。
      1998年)(,由)(于)(仿)(制)(药)(药)(效)(低)(下)(,日)(本)(启)(动)(“药)(品)(品)(质)(再)(评)(价)(工)(程)(”,对)(于)(药)(效)(达)(不)(到)(要)(求)(的)(药)(品)(,管)(理)(部)(门)(给)(予)(企)(业)(一)(定)(时)(间)(,允)(许)(其)(二)(次)(开)(发)(,在)(这)(一)(时)(间)(内)(还)(无)(法)(完)(成)(的)(就)(必)(须)(撤)(销)(批)(号)(。
      20世)(纪)(70年)(代)(,美)(国)(也)(通)(过)(生)(物)(等)(效)(性)(评)(价)(,淘)(汰)(了)(约)(6000种)(不)(合)(格)(药)(品)(。
      一)(旦)(动)(真)(格)(提)(升)(药)(效)(,就)(意)(味)(着)(要)(砍)(掉)(一)(大)(批)(不)(合)(格)(的)(药)(企)(。计)(划)(2015年)(完)(成)(的)(570种)(药)(品)(,每)(年)(为)(药)(品)(行)(业)(创)(造)(大)(量)(的)(产)(值)(。地)(方)(食)(品)(药)(品)(检)(验)(所)(的)(官)(员)(表)(示)(,“革)(命)(就)(要)(动)(既)(得)(利)(益)(者)(的)(奶)(酪)(,不)(规)(范)(的)(药)(厂)(将)(损)(失)(最)(大)(,而)(它)(们)(都)(是)(在)(当)(地)(很)(有)(影)(响)(力)(的)(企)(业)(,必)(然)(试)(图)(影)(响)(相)(关)(部)(门)(的)(决)(策)(者)(。”
      持)(有)(仿)(制)(药)(批)(号)(的)(药)(厂)(,多)(是)(地)(方)(利)(税)(大)(户)(,解)(决)(当)(地)(就)(业)(问)(题)(,一)(直)(受)(到)(地)(方)(保)(护)(主)(义)(的)(庇)(护)(。
      中)(国)(医)(药)(联)(盟)(发)(布)(的)(一)(项)(“中)(国)(药)(企)(员)(工)(人)(数)(排)(行)(榜)(”显)(示)(,162家)(上)(市)(药)(企)(总)(人)(数)(近)(52万)(人)(,占)(中)(国)(总)(人)(口)(数)(的)(万)(分)(之)(四)(,表)(明)(2500人)(中)(就)(有)(一)(个)(医)(药)(人)(。
      另)(一)(方)(面)(,一)(些)(药)(品)(行)(业)(协)(会)(、药)(企)(力)(推)(这)(项)(工)(作)(,辐)(射)(到)(政)(府)(部)(门)(的)(压)(力)(也)(大)(。中)(检)(院)(一)(名)(仿)(制)(药)(一)(致)(性)(评)(价)(工)(作)(负)(责)(人)(卸)(任)(后)(,在)(微)(信)(朋)(友)(圈)(感)(叹)(说)(,“终)(于)(可)(以)(睡)(个)(踏)(实)(觉)(了)(。”这)(引)(发)(明)(白)(个)(中)(缘)(由)(的)(友)(人)(纷)(纷)(点)(赞)(。中)(检)(院)(负)(责)(仿)(制)(药)(一)(致)(性)(评)(价)(工)(作)(标)(准)(制)(定)(与)(执)(行)(,该)(负)(责)(人)(所)(在)(的)(部)(门)(经)(常)(受)(到)(上)(级)(单)(位)(与)(媒)(体)(的)(质)(疑)(。
      “要)(推)(动)(这)(项)(工)(作)(,必)(须)(有)(一)(个)(正)(确)(的)(工)(作)(理)(念)(,是)(为)(了)(促)(进)(民)(众)(安)(全)(有)(效)(用)(药)(,而)(不)(能)(过)(多)(考)(虑)(药)(企)(的)(生)(死)(存)(亡)(。”孙)(新)(生)(说)(。
      2015年)(下)(半)(年)(,相)(关)(部)(门)(动)(作)(频)(繁)(。7月)(22日)(,食)(药)(监)(总)(局)(启)(动)(药)(物)(临)(床)(试)(验)(数)(据)(真)(实)(性)(核)(查)(工)(作)(;7月)(31日)(晚)(,该)(局)(再)(发)(加)(快)(解)(决)(药)(品)(注)(册)(申)(请)(积)(压)(问)(题)(征)(求)(意)(见)(公)(告)(;8月)(18日)(,国)(务)(院)(发)(布)(《关)(于)(改)(革)(药)(品)(医)(疗)(器)(械)(审)(评)(审)(批)(制)(度)(的)(意)(见)(》,核)(心)(就)(是)(提)(高)(药)(品)(的)(质)(量)(,通)(过)(改)(革)(来)(促)(进)(医)(药)(行)(业)(产)(业)(的)(结)(构)(调)(整)(和)(转)(型)(升)(级)(。其)(中)(明)(确)(提)(出)(,力)(争)(2018年)(底)(前)(,完)(成)(国)(家)(基)(本)(药)(物)(口)(服)(制)(剂)(的)(一)(致)(性)(评)(价)(工)(作)(。届)(时)(,未)(通)(过)(评)(价)(的)(基)(药)(口)(服)(仿)(制)(药)(,可)(能)(不)(得)(上)(市)(。这)(显)(示)(了)(整)(顿)(仿)(制)(药)(的)(紧)(迫)(性)(。
      上)(述)(药)(业)(资)(深)(人)(士)(估)(计)(,“一)(致)(性)(评)(价)(可)(能)(会)(刷)(下)(一)(大)(批)(药)(品)(批)(准)(文)(号)(。”
      而)(具)(有)(竞)(争)(力)(的)(企)(业)(也)(随)(风)(而)(动)(。齐)(鲁)(制)(药)(成)(立)(了)(一)(个)(旨)(在)(提)(高)(质)(量)(与)(药)(效)(的)(精)(品)(工)(程)(项)(目)(。评)(价)(工)(作)(由)(每)(个)(药)(品)(的)(原)(研)(发)(团)(队)(进)(行)(,原)(研)(药)(由)(各)(团)(队)(上)(报)(,负)(责)(采)(购)(的)(部)(门)(统)(一)(采)(购)(。张)(明)(会)(说)(,“要)(在)(原)(研)(方)(面)(投)(入)(更)(大)(精)(力)(与)(资)(金)(,因)(为)(审)(批)(将)(趋)(向)(严)(格)(,好)(的)(影)(响)(是)(,仿)(制)(药)(审)(批)(的)(速)(度)(有)(望)(加)(快)(。”
      经)(历)(过)(几)(轮)(大)(型)(的)(整)(顿)(活)(动)(,可)(以)(预)(见)(很)(多)(靠)(以)(前)(的)(批)(准)(文)(号)(吃)(老)(本)(、缺)(乏)(创)(新)(和)(提)(升)(质)(量)(能)(力)(的)(药)(企)(,一)(旦)(失)(去)(批)(号)(也)(就)(被)(淘)(汰)(了)(。随)(之)(,参)(与)(仿)(制)(药)(的)(企)(业)(将)(减)(少)(。
      不)(过)(,张)(明)(会)(表)(示)(,对)(制)(药)(行)(业)(的)(整)(顿)(不)(能)(依)(靠)(一)(阵)(风)(或)(者)(疾)(风)(暴)(雨)(似)(的)(改)(革)(,而)(是)(要)(制)(定)(长)(久)(的)(、连)(贯)(的)(、科)(学)(规)(范)(的)(管)(理)(制)(度)(与)(规)(范)(。由)(春)(娜)(认)(为)(,接)(下)(来)(的)(标)(准)(制)(定)(与)(企)(业)(自)(查)(阶)(段)(也)(不)(能)(过)(急)(推)(进)(。
      仿)(制)(药)(药)(效)(攸)(关)(全)(体)(国)(民)(的)(生)(命)(健)(康)(。自)(2015年)(7月)(以)(来)(,一)(场)(大)(刀)(阔)(斧)(的)(变)(革)(在)(中)(国)(药)(品)(行)(业)(风)(声)(雷)(动)(。然)(而)(,诸)(种)(弊)(端)(能)(否)(随)(药)(品)(市)(场)(的)(大)(洗)(牌)(得)(到)(清)(算)(与)(整)(顿)(,中)(国)(仿)(制)(药)(的)(药)(效)(问)(题)(能)(否)(迎)(刃)(而)(解)(,仍)(是)(一)(个)(巨)(大)(问)(号)(。
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