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浅析医疗器械新版GMP的痛点和机遇

欧洲杯直播tzverify 2016-02-17 LIULANCISHU:2863

浅析医疗器械新版GMP的痛点和机遇

    SANFENFULUGUIDINGLEZHEIJILEIYILIAOQIXIEZAISHENGCHANZHILIANGGUANLIGUIFANZHONGDETESHUYAOQIU,BAYILIAOQIXIEGMPGUIFANTIXIYOUTUISHANGLEYIGEXINTAIJIE,ZHEIJISHIGUANCHEXINBAN《YILIAOQIXIEJIANDUGUANLITIAOLI》(YIXIAJIANCHENG《TIAOLI》)YIJI《YILIAOQIXIESHENGCHANJIANDUGUANLIBANFA》(YIXIAJIANCHENG《BANFA》)DEXUYAO,YOUSHIGUANLIBUMENNULIDAZAOWOGUOYILIAOQIXIEGMPSHENGJIBANDETIXIAN。  

  一、立法进展  

  WOGUODUIYILIAOQIXIESHENGCHANZHILIANGGUANLITIXIDETANSUO,SHICONGZHIRUXINGYILIAOQIXIEYIJIWUJUNYILIAOQIXIEKAISHIRUSHOUDE。ZAOZAI2002NIAN,YUANGUOJIAYAOPINJIANDUGUANLIJUJIUFABULE《WAIKEZHIRUWUSHENGCHANSHISHIXIZE》,KAISHIDUIZHIRUXINGYILIAOQIXIEDESHENGCHANZHILIANGJINXINGYANGEGUANLI。ZAICIHOUJINSHINIANDESHIJIANLI,YIZHIANZHAOGAIXIZEDUIZHIRUXINGYILIAOQIXIEJINXINGTIXIJIANCHA。  

  LINGWAI,YUANGUOJIAYAOPINJIANDUGUANLIJUCENGYU2001、2002NIANXIANHOUFABU《YICIXINGSHIYONGWUJUNYILIAOQIXIECHANPIN(ZHU、SHUQIJU)SHENGCHANSHISHIXIZE》HE《YICIXINGSHIYONGMAZUICHUANCIBAOSHENGCHANSHISHIXIZE》LIANGFENGUIFANXINGWENJIAN。2007NIANBANBU《TIWAIZHENDUANSHIJISHENGCHANSHISHIXIZE(SHIXING)》。ZAIYUANBANYILIAOQIXIEGMPSHISHIZHIQIAN,ZHEIXIEGUIFANXINGWENJIANDUIJIAQIANGBUFENYILIAOQIXIESHENGCHANZHILIANGDEGUANLIFAHUILEJIAODAZUOYONG。  

  2009NIAN12YUE,YUANGUOJIASHIPINYAOPINJIANDUGUANLIJU(SFDA)FABULE《YILIAOQIXIESHENGCHANZHILIANGGUANLIGUIFAN(SHIXING)》,SHOUCIDUIYILIAOQIXIESHENGCHANHUANJIEDEZHILIANGGUANLIHUODONGJINXINGLEXITONGGUIFAN。ZAICIJICHUSHANG,SFDALIANFA《WUJUNYILIAOQIXIESHISHIXIZE(SHIXING)》HE《ZHIRUXINGYILIAOQIXIESHISHIXIZE(SHIXING)》LIANGDAXIZE,BINGJIUZHIRUXINGYILIAOQIXIEHEWUJUNYILIAOQIXIEBANBUXIANGYING《JIANCHAPINGDINGBIAOZHUN》,CHUBUGOUJIANLEYIYILIAOQIXIEGMPGUIFANWEILONGTOUDEYILIAOQIXIESHENGCHANZHILIANGGUANLIGUIFANTIXI。  

  SHIGEWUNIANZHIHOU,GUOJIASHIPINYAOPINJIANDUGUANLIZONGJU(CFDA)FABULEXINBAN《GUIFAN》,BINGQIDONGLEPEITAOXIZEDEXIUDINGGONGZUO。2015NIAN1YUE,CFDAFABU《YILIAOQIXIESHENGCHANQIYEGONGYINGSHANGSHENHEZHINAN》,WEIYILIAOQIXIESHENGCHANQIYESHENHEXUANZEGONGYINGSHANGZHIMINGLEYUANZEHEFANGXIANG。2YUE,CFDAJIUYILIAOQIXIESHENGCHANZHILIANGGUANLIGUIFANWUJUNYILIAOQIXIEFULUHEZHIRUXINGYILIAOQIXIEFULUXIANGGONGZHONGGONGKAIZHENGQIUYIJIAN。7YUE,XIANGGUANFULUGONGBUBINGYAOQIUZI10YUE1RIKAISHISHISHI。  

  ZHEIXIELEILIFENGXINGDELIFAHUODONG,TIXIANLECFDAJIAQIANGYILIAOQIXIESHENGCHANZHILIANGGUANLI,SHENGJIYILIAOQIXIEGMPGUIFANTIXIDEJUEXIN。  

  二、管理愿景  

  CONG《TIAOLI》、《BANFA》DAO《GUIFAN》、《FULU》YIJI《JIANCHAPINGDINGBIAOZHUN》,CONGSHANGZHIXIAWEIRAOSHENGCHANZHILIANGGUANLIXINGCHENGLEYILIAOQIXIEGMPGUIFANTIXI。TAMENSHIWEILAIYIDUANSHIJIANNEISHENGCHANQIYEJIANLIYUYUNXINGYILIAOQIXIESHENGCHANZHILIANGGUANLITIXIDEZONGYAOQIU,JIANGDUIZHONGDUOYILIAOQIXIESHENGCHANQIYECHANSHENGZHONGDAYINGXIANG。GUANLIBUMENXIWANGTONGGUOGAIGUIFANTIXIDEGOUJIANHESHISHI,DUIYILIAOQIXIESHENGCHANZHILIANGZUODAOYOUXIAOGUANLI。  

  CONGGUANLIMUBIAOSHANGKAN,GAIGUIFANTIXIYAOYOUZHUYUZHENGQUEPINGJIAQIYESHENGCHANZHILIANGGUANLITIXIDEHEGUIXING、YOUXIAOXING、ZHENSHIXING。SUOYOUXIANGGUANGUIZHIYAOYOULIYULUOSHIFENGXIANGUANLI、QIYEZEREN、ZHILIANGJIANKONG、GUOCHENGJIANGUANDENGYAOQIU。DANSHIYILIAOQIXIESHULIANGZHONGDUO,QIYESHENGCHANFANGSHIBUYI,DADAZENGJIALESHIXIANZHEIXIEGUANLIMUBIAODENANDU。  

  WEICI,GUOJIADUIYILIAOQIXIESHENGCHANZHILIANGDEGUANLICAIQULEZHUBUTUIJINDEFANGFA,XIANCONGGUIFANZHIRUXINGHEWUJUNYILIAOQIXIEDESHENGCHANZHILIANGGUANLIRUSHOU,ZAIJINERLUOSHITIWAIZHENDUANSHIJIDENGQITAYILIAOQIXIEDEZHILIANGGUANLI。  

  ZAI《GUIFAN》DEJICHUSHANG,FENBIEZHIDING《FULU》YIJI《JIANCHAPINGDINGBIAOZHUN》,ZAIZHENDUIBUTONGLEIBIE、BUTONGSHENGCHANGUOCHENG、BUTONGZHILIANGYAOQIUFENMENBIELEIZHIDINGFUHE《GUIFAN》YIJI《FULU》YAOQIUDEJIANCHAZHIDAOYUANZE。TAMENZUOWEIXINGZHENGXUKEJIANDUJIANCHADECANKAOBIAOZHUNHEYIJU,DUIQIYESHENGCHANZHILIANGTIXIDENEIBUSHENHEHEJIANGUANBUMENDEWAIBUJIANCHAJUNYOUZHONGYAOYIYI。

  三、实施瓶颈  

  XINBANYILIAOQIXIEGMPGUIFANTIXISHIZAIJIEJIANGUOJIZHILIANGGUANLITIXICHENGSHUJINGYANDEJICHUSHANGXINGCHENGDE,DUITIXIDEJIANCHA,BUGUANSHIMEIGUOFDADEQSITMOSHI,HAISHIISO13485CHANGDAODEQIYEZICHAMOSHI,DOUBUNENGZHIJIEZHAOBANDAOWOGUODEGUANLISHIJIANZHONGLAI。  

  GENJUWOGUODEJUTIGUOQING,WOMENXUANQULEYIZHONGZHENGFUZHUDAODEGUANLIMOSHI。GAIMOSHIDECHENGGONGJIAODACHENGDUSHANGQUJUEYUYIZHIZHUANYEJINGGANDEJIANCHAYUANDUIWU。DANGQIAN,WOGUODUIJIANCHAYUANJIQUEFATONGYICHIXUDEJIAOYUPEIXUN,YOUQUEFAZHUANYEKEXUEDERENCAIBIAOZHUN,ZHISHIJIANCHAYUANRENCAIDUIWUJIANSHEYANZHONGZHIHOU,ZHEIYIJINGCHENGWEIZHIYUE《GUIFAN》SHISHICHENGGONGDEPINGJINGZHIYI。  

  2011NIAN1YUEYUANBANYILIAOQIXIEGMPZHENGSHISHISHISHI,YOURENJIANGTACHENGZHIWEIYILIAOQIXIESHENGCHANQIYEDE“SHENGSIXIAN”,XINGXIANGDISHUOMINGLEYILIAOQIXIEGMPDUISHENGCHANQIYEFAZHANDEJUEDINGXINGYINGXIANG,QIYEDUICIZIRANSHIFENZHONGSHI。  

  JIUQIYUANYIN,YISHIYILIAOQIXIEGMPJISHISHENGCHANQIYEJIANLIHEWEIHUSHENGCHANZHILIANGGUANLITIXIDEZHIJIEYIJU,YOUSHIDIYILEIYILIAOQIXIESHENGCHANQIYEBEIANJIANCHADEYIJU;ERSHIQIYEBUNENGTONGGUOYILIAOQIXIEGMPJIANCHA,JIANGZHIJIEYINGXIANG《YILIAOQIXIESHENGCHANXUKEZHENG》DESHENQINGSHENPI。SHENGCHANQIYESHIFOUTONGGUOJIANCHA,XUYAOJIANCHAYUANXIANCHANGJIANCHACAINENGZUOCHUJIELUN。  

  MUQIAN,JIANCHAYUANZAISHIYONG《XIZE》、《JIANCHAPINGDINGBIAOZHUN》DENGJINXINGTIXIJIANCHASHI,DUIQIYE“YANZHONGBUHEGE”XIANGDEPANDINGCAILIANGKONGJIANJIAODA,ZHEIDUIQIYESHIFOUTONGGUOJIANCHADEJIELUNYINGXIANGJIAODA。DUI“BUYUTONGGUO”DEJIANCHAJIELUN,QIYEHAIQUEFAXIANGYINGDEQUANLIJIUJITUJING。  

  XINBANYILIAOQIXIEGMPSHISHISUIRANBUJIU,DANYUDAODEWENTIJIAODUO,YOUDEHAIBIJIAOJISHOU。SHENGCHANQIYEWEITUOSHENGCHAN、FENBAOSHENGCHAN、TIEBIAOQIANSHENGCHAN、LINGBUJIANJIAGONGZAITONGYIZHUANGPEIDENGDUOZHONGSHENGCHANZUZHIFANGSHIDUIYILIAOQIXIEGMPDESHISHITICHULEYANJUNTIAOZHAN。ZHEIXIESHENGCHANQIYEGUANLISHUIPINGBUYI、SHENGCHANFANGSHILINGHUODUOBIAN、SHOUFAYISHIQIANGRUOYOUBIE,DUIYILIAOQIXIEGMPGUIFANDELUODISHENGXIAODAILAILEBUXIAODEYINGXIANG。  

  GENJUYOUGUANANPAI,ZI2014NIAN10YUE1RIQI,FANXINKAIBANYILIAOQIXIESHENGCHANQIYE、XIANYOUYILIAOQIXIESHENGCHANQIYEZENGJIASHENGCHANDISANLEIYILIAOQIXIE、QIANYIHUOZHEZENGJIASHENGCHANCHANGDIDE,BIXUFUHEYILIAOQIXIESHENGCHANZHILIANGGUANLIGUIFANDEYAOQIU。ZI2016NIAN1YUE1RIQI,SUOYOUDISANLEIYILIAOQIXIESHENGCHANQIYEYINGDANGFUHEYILIAOQIXIESHENGCHANZHILIANGGUANLIGUIFANDEYAOQIU。ZI2018NIAN1YUE1RIQI,SUOYOUYILIAOQIXIESHENGCHANQIYEYINGDANGFUHEYILIAOQIXIESHENGCHANZHILIANGGUANLIGUIFANDEYAOQIU。  

  YINCI,GUANGDAYILIAOQIXIESHENGCHANQIYEYINGDANGJIJIANZHAOYILIAOQIXIESHENGCHANZHILIANGGUANLIGUIFANJIXIANGGUANYAOQIUJINXINGDUIZHAOZHENGGAI,BUDUANWANSHANZHILIANGGUANLITIXI,QUANMIANTISHENGZHILIANGGUANLIBAOZHANGNENGLI,YIZAIGUIDINGSHIXIANNEIDADAOYILIAOQIXIEGMPDEYAOQIU。  

  四、改进路径  

  CONGCFDACICIFABUSANFENYILIAOQIXIESHENGCHANZHILIANGGUANLIGUIFANFULUDEQINGXINGKAN,GUANLIBUMENGAIBIANLEBA《GUIFAN》HE《XIZE》BINGLIEDEXIANZHUANG,ERBAYUAN《XIZE》ZHUANBIANWEI《GUIFAN》DEFULU,ZHEIYANGSANFENFULUJIUCHENGLE《GUIFAN》DEYIBUFEN。JIEXIALAI,HAIYAOZHIDINGDUITONGYONGCHANPINDEXIANGGUANGUIDING。ZAIZHEIXIEGUIFANXINGWENJIANDEZHIXIUDINGGUOCHENGZHONG,FEICHANGYOUBIYAODALITINGQUQIYEYIJIAN,SHENRUDIAOYANZUODAOKEXUEMINZHU。  

  LINGWAI,ZAIZHILIANGTIXIJIANCHAZHONG,JIANCHAYUANYUQIYEYINGGAIZUODAOLIANGXINGHUDONG,TONGGUOGONGTONGLUNZHENG、XUNZHENG、YANZHENG,SHENRUFENXIQIYEZHILIANGTIXIZHONGCUNZAIDEWENTI、QUEXIAN、FENGXIAN,DUIZHILIANGGUANLITIXISHIFOUYOUXIAOYUNXINGZUOCHUKEGUANZHUNQUEDEPANDUAN。JIANCHAYUANYINGBENZHEBANGZHUQIYETISHENGZHILIANGGUANLITIXISHUIPINGDECHUZHONG,ERBUSHISHENHEJIUCUODEXINTAILAIJINXINGJIANCHA。  

  QICI,JIANYIZAIZHIDUSHANGYINGQUELISHENGCHANQIYETONGBUGUOJIANCHADEQUANLIJIUJICUOSHI。BUGUANSHIYIJIANSHENSU,HAISHIJIELUNFUCHA,DOUYINGGAIYOUGUIKEXUN、YOUJUKEYI,SHISHENGCHANQIYESHENGCHANZHILIANGGUANLITIXIDEJIANCHAJIEGUO,JINKENENGDISHAOSHOUJIANCHAYUANZHUANYESHUIPING、GOUTONGNENGLIYIJIGERENSUYANGDENGYINSUDEYINGXIANG。ZHEIDUIYUTUIDONGYILIAOQIXIEGMPGUIFANSHUNLISHISHIJIANGDAYOUBIYI!    ZUIHOU,YINGJIAKUAIYILIAOQIXIEJIANDUJIANCHAYUANDUIWUNENGLIJIANSHE,TIGAOJIANGUANRENYUANDENENGLIHESHUIPING。JINKUAICHUTAISHISHI《YILIAOQIXIEJIANDUJIANCHAYUANGUANLIBANFA》,SHIJIANCHAYUANDUIWUJIANSHEZOUSHANGFAZHIGUIDAO。QIYEYEYINGLIBINGMOMAXIANXINGZHANGWOGUIFANNEIRONG,JIZAOYINGDUIXINYILUNYILIAOQIXIEGMPDEJIANCHA,LIQIUZAISHISHIQIXIANNEIMANZUYAOQIU。