FABUSHIHOU: 2017-08-10
WEIGUANCHELUOSHI《GUOWUYUANDUIYUDINGXINYAOPINYILIAODONGXISHENPINGSHENPIGUIZHIDEDINGJIAN》（GUOFA〔2015〕44 HAO），JIANHUAYAOPINSHENPIFASHI，JIANGJIANJIEDAZHANGYAOPINDEBAOZHUANGCAILIAOHERONGQI（YIXIAJIANCHENGYAOBAOCAI）、YAOYONGFULIAOYOULINGDINGSHENXIUGAIWEIZAISHENPIYAOPINZHUCEQINGQIUSHIYIBINGSHENPINGSHENPI。XIANJIUYOUGUANSHIBIANGAOSUBUGAOYIXIA:
YI、ZAIZHONGHUAGUOMINGONGHEGUOJINGNEIYANZHI、CHUCHAN、RUKOUHELIYONGDEYAOBAOCAI、YAOYONGFULIAO，HEYONGBENGAOSUBUGAOQINGQIU。RUKOUYAOPINZHONGSUOYONGDEYAOBAOCAI、YAOYONGFULIAOGENJU《YAOPINZHUCEBANLIFANGFA》DEXIANGGANHUADINGLVXING。
ER、GUODUSHIWUYAOPINJIANSHIBANLIZONGJUGENJUWEIXIANBANLIDEZHUNSHENGZAISHENPIYAOPINZHUCEQINGQIUSHIDUIYAOBAOCAI、YAOYONGFULIAOSHISHIJIEQIAGANXISHENPINGSHENPI。GUODUSHIWUYAOPINJIANSHIBANLIZONGJUNIDINGBANBUSHISHIJIEQIAGANXISHENPINGSHENPIDEYAOBAOCAI、YAOYONGFULIAOGUIMO（JIANFUJIAN 1），BINGGENJURENWUXUYAOTINGZHIDIAOJIHEWANMEI。ZANWEICANJIAJIEQIAGANXISHENPINGSHENPIGUIMODEYAOBAOCAI、YAOYONGFULIAOYINGHESHIYAOYONGQINGQIU。
SAN、ZIBENGAOSUBUGAOFABUZHIRIQI，YAOBAOCAI、YAOYONGFULIAOYINGANFASHI（JIANFUJIAN 2）YUYAOPINZHUCEQINGQIUJIEQIAGANXIBAOGAOHESHENPINGSHENPI，《YAOBAOCAIJIYAOYONGFULIAOBAOGAOCAILIAOQINGQIU》LINGXINGBANBU。GEJISHIWUYAOPINJIANSHIBANLIBUFENBUZAILINGDINGSHOULIYAOBAOCAI、YAOYONGFULIAOZHUCEQINGQIU，BUZAILINGDINGHEFAXIANGGANZHUCEPIZHUNZHENGSHIWENJIAN。
SI、YAOBAOCAI、YAOYONGFULIAOCHANSHENGZHUANBIANCHUFANG、GONGYI、PINZHIGUIFANDENGYINGXIANGCHANWUPINZHIDEBIANGESHI，QICHUCHANQIYEYINGZIDONGZHANKAIXIANGYINGDEPINGGU，SHISHIGAOSUYAOPINCHUCHANQIYE，BINGANQINGQIUXIANGSHIWUYAOPINJIANSHIBANLIBUFENBAOSONGXIANGGANCAILIAO。YAOBAOCAI、YAOYONGFULIAOBIANGEDEXIANGGANQINGQIUYOUGUODUSHIWUYAOPINJIANSHIBANLIZONGJULINGXINGNIDING。
WU、YIPIZHUNDEYAOBAOCAI、YAOYONGFULIAO，QIPIZHUNZHENGSHIWENJIANZAIXIAOQINEICHIXUYOUYONG。YOUYONGQIJIEMANHOU，KECHIXUZAIYUANYAOPINZHONGLIYONG。RUYONGYUQIYUYAOPINDEYAOWULINCHUANGSHIYANHUOCHUCHANQINGQIUSHI，YINGANBENGAOSUBUGAOQINGQIUBAOSONGXIANGGANCAILIAO。
PIZHUNZHENGSHIWENJIANZAI 2017 NIAN 12 YUE 31 RI（HANDANGRI）QIANDAOQIDEYAOBAOCAI、YAOYONGFULIAO，YOUYONGQICHIXUZHI 2017 NIAN 12 YUE 31 RI。ZI 2018 NIAN 1 YUE 1 RIQI，YONGYUQIYUYAOPINDEYAOWULINCHUANGSHIYANHUOCHUCHANQINGQIUSHI，YINGANBENGAOSUBUGAOQINGQIUBAOSONGXIANGGANCAILIAO。
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LIU、YAOBAOCAI、YAOYONGFULIAOCHUCHANQIYEYINGDACHANWUPINZHIDANREN；YINGZAIZHIZUXIANGYINGCHUCHANWUZHIBANLIQINGQIUDEQIANTIXIAGOUZAOCHUCHAN；YINGGONGTONGYAOPINCHUCHANQIYEZHANKAIGONGJISHANGSHENJI。
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BA、YAOBAOCAI、YAOYONGFULIAOCHUCHANQIYEDIDIANDIDESHIWUYAOPINJIANSHIBANLIBUFENYINGJIANGXINGZHENGDIQUNEIYAOBAOCAI、YAOYONGFULIAOCHUCHANQIYEGUIRUPINGCHANGJIXIGUIMO。GUODUSHIWUYAOPINJIANSHIBANLIZONGJUGENJUXUYAODUIRUKOUYAOBAOCAI、YAOYONGFULIAOCHUCHANQIYETINGZHIJIANSHICHACHAO。
JIU、BENGAOSUBUGAOZIJUEBUZHIRIQISHISHI。CIQIANYISHOULIDEYAOPIN、YAOBAOCAIHEYAOYONGFULIAOZHUCEQINGQIUCHIXUANYUANHUADINGSHENPINGSHENPI，CIQIANYAOPIN、YAOBAOCAIHEYAOYONGFULIAOSHENPINGSHENPIQINGQIUYUBENGAOSUBUGAOBUFENQIDE，YIBENGAOSUBUGAOWEIZHUN。
TECIGAOSUBUGAO。
附件: 1.实施接洽干系审评审批的药包材和药用辅料规模（试行）
2. 药包材、药用辅料与药品接洽干系审评审批法式（试行）
SHIWUYAOPINJIXIZONGJU
2016 NIAN 8 YUE 9 RI
附件 1
实施接洽干系审评审批的药包材和药用辅料规模（试行）
DIYIBUFEN YAOBAOCAI
ZHU:
1.GAOWEIXIANYAOBAOCAIPUTONGBAOHAN: YONGYUXIRUZHIJI、DAZHENJI、YANYONGZHIJIDEYAOBAOCAI；XINCAILIAO、XINBUJU、XINYONGCHUDEYAOBAOCAI；GUODUSHIWUYAOPINJIANSHIBANLIZONGJUGENJUJIANCESHUJUCHUGEQINGQIUJIXIDEYAOBAOCAI。
2.GUDONGMIANLIGENJUBAOZHUANGTIXITINGZHIQINGQIU，RUOSHIYOUYUYIXIEJISHUYUANYOUBUNENGGENJUWANQUANDEBAOZHUANGTIXITINGZHIQINGQIU，YENENGGOUGENJUBAOZHUANGZUJIANTINGZHIQINGQIU。
DIERBUFEN YAOYONGFULIAO
YI、JINGBIAOLISHANGSHIZHIJIZHONGWEILIYONGGUODEYAOYONGFULIAO；
ER、JINGWAISHANGSHIZHIJIZHONGYILIYONGERZAIJINGNEISHANGSHIZHIJIZHONGWEILIYONGGUODEYAOYONGFULIAO；
SAN、JINGNEISHANGSHIZHIJIZHONGYILIYONG，WEIHUODEPIZHUNZHENGSHIWENJIANHUOPIZHUNBIANHAODEYAOYONGFULIAO；
SI、YIHUODEPIZHUNZHENGSHIWENJIANHUOPIZHUNBIANHAODEYAOYONGFULIAOZHUANBIANJIYAOLUZIHUOJINBULIYONGXIANLIANG；
WU、GUODUSHIWUYAOPINJIANSHIBANLIZONGJUHUADINGDEQIYUYAOYONGFULIAO。
ZHU:
1.GAOWEIXIANYAOYONGFULIAOPUTONGBAOHAN: ZHIWUYUANMOURENYUANDEYAOYONGFULIAO；YONGYUXIRUZHIJI、DAZHENJI、YANYONGZHIJIDEYAOYONGFULIAO；GUODUSHIWUYAOPINJIANSHIBANLIZONGJUGENJUJIANCESHUJUCHUGEQINGQIUJIXIDEYAOYONGFULIAO。JINGBIAOLISHANGSHIZHIJIZHONGWEILIYONGGUODEYAOYONGFULIAOGENJUGAOWEIXIANYAOYONGFULIAOTINGZHIBANLI。
2.YIZAIPIZHUNSHANGSHIDEYAOPINZHONGCHIJIULIYONG，QIEYONGYUBUFENJINGPIHUOKOUFULUZIWEIXIANJIAODIDEFULIAO，RUJIAOWEIJI、TIANWEIJI、XIANGJING、SESUDENGLVXINGXIANGYINGXINGYEGUIFAN，BUGUIRUBENMUCI。
附件 2
药包材、药用辅料与药品接洽干系审评审批法式（试行）
YI、YAOBAOCAI、YAOYONGFULIAOYINGYUYAOWULINCHUANGSHIYANHUOCHUCHANQINGQIUJIEQIAGANXIBAOGAO，YAOBAOCAI、YAOYONGFULIAOCHUCHANQIYEYINGTIANXIE《YAOBAOCAIBAOGAOBIAO》HUO《YAOYONGFULIAOBAOGAOBIAO》，SHENMINGSUOJIEQIAGANXIDEYAOPINZHUCEQINGQIUDEQINGQIUREN、YAOPINCHENGHAOHESHOULIHAO，XIANGDIDIANDISHENGJISHIWUYAOPINJIANSHIBANLIBUFENZHAOSHITIJIAOBAOGAOCAILIAO，RUKOUYAOBAOCAI、YAOYONGFULIAOCHUCHANQIYEXIANGGUODUSHIWUYAOPINJIANSHIBANLIZONGJUXINGZHENGSHIBIANSHOULIBANSHIHEZANYANGGAOFAZHONGJIAN（YIXIAJIANCHENGSHIWUYAOPINJIXIZONGJUSHOULIHEGAOFAZHONGJIAN）TIJIAOBAOGAOCAILIAO。
YAOPINZHUCEQINGQIURENZAITIJIAOYAOPINZHUCEQINGQIUSHI，ZAIYAOPINZHUCEQINGQIUBIAOZHONG“YAOBAOCAILAIYUAN”HE“YUANFULIAOLAIYUAN”MINGMUZHONGYINGSHENMINGQUANSHUJIEQIAGANXIDEYAOBAOCAIHEYAOYONGFULIAODEXIANGGANXINXI。
ER、SHENGJISHIWUYAOPINJIANSHIBANLIBUFENHUOSHIWUYAOPINJIXIZONGJUSHOULIHEGAOFAZHONGJIANYINGGENJU《YAOBAOCAIJIYAOYONGFULIAOBAOGAOCAILIAOQINGQIU》，DUIBAOGAOCAILIAOMINGMUHEXIANGGANZHENGSHIXINGWENJIANTINGZHIQINGSHIJIANCHA，HESHIQINGQIUDEYUYISHOULIBINGHEFA《SHOULIGAOSUSHU》，ANHUADINGXUYAOCHAYANDE，TONGSHIHEFA《CHAYANGAOSUSHU》。
YISHOULIDEYAOBAOCAI、YAOYONGFULIAO，YONGYUQIYUYAOPINDEYAOWULINCHUANGSHIYANHUOCHUCHANQINGQIUSHI，KEGONGJIGAIYAOBAOCAI、YAOYONGFULIAO《SHOULIGAOSUSHU》，WUXUFANFUTIJIAOXIANGGANCAILIAO。
SAN、DUIBENGAOSUBUGAOZHONGHUADINGDEGUOCHANGAOWEIXIANYAOBAOCAI、YAOYONGFULIAO，QICHUCHANQIYEZAIJIEQIAGANXIBAOGAOSHI，YINGTIJIAO《YAOBAOCAIJIYAOYONGFULIAOYANZHIHUANJINGBAOGAOBIAO》；SHENGJISHIWUYAOPINJIANSHIBANLIBUFENYINGZAISHOULIHOU 30 RINEISHIXIANXIANCHANGHEDUI，CHOUQUCHIXUCHUCHANDE 3 PIYANGPINSONGSHENGJICHAYANJIGOUCHAYAN，BINGJIANGBAOGAOCAILIAO、《SHOULIGAOSUSHU》《CHAYANGAOSUSHU》HE《YAOBAOCAIJIYAOYONGFULIAOXIANCHANGHEDUIBAOGAOBIAO》DENGXIANGGANCAILIAOBAOSONGGUODUSHIWUYAOPINJIANSHIBANLIZONGJUYAOPINSHENPINGZHONGJIAN（YIXIAJIANCHENGSHIWUYAOPINJIXIZONGJUYAOSHENZHONGJIAN）。CHAYANJIGOUYINGZAIJIEDAOCHAYANGAOSUHEYANGPINHOU 60 RINEISHIXIANCHAYAN，JIANGCHAYANBAOGAOSHUBAOSONGSHIWUYAOPINJIXIZONGJUYAOSHENZHONGJIAN。
DUIBENGAOSUBUGAOZHONGHUADINGDERUKOUGAOWEIXIANYAOBAOCAI、YAOYONGFULIAO，SHIWUYAOPINJIXIZONGJUSHOULIHEGAOFAZHONGJIANSHOULIHOU，GAOSUZHONGGUOSHIWUYAOPINJIANDINGYANTAOYUANGOUZAODUI 3 PIYANGPINTINGZHIZHUCECHAYAN，CHAYANJIGOUYINGZAIJIEDAOCHAYANGAOSUHEYANGPINHOU 60 RINEISHIXIANCHAYAN，JIANGCHAYANBAOGAOSHUBAOSONGSHIWUYAOPINJIXIZONGJUYAOSHENZHONGJIAN。SHIWUYAOPINJIXIZONGJUYAOSHENZHONGJIANZAIJISHUSHENPINGSHIDAIKEJIYUWEIXIANPINGGUQINGQIUZHANKAIXIANCHANGHEDUI。
DUIFEIGAOWEIXIANDEYAOBAOCAI、YAOYONGFULIAO，BAOGAODANWEIZAIBAOGAOCAILIAOZHONGYINGGONGJICHIXUCHUCHANDE3 PICHANWUDECHAYANBAOGAOSHU。SHIWUYAOPINJIXIZONGJUYAOSHENZHONGJIANZAIJISHUSHENPINGSHIDAIKEJIYUWEIXIANPINGGUQINGQIUZHANKAIXIANCHANGHEDUI。
SI、SHENGJISHIWUYAOPINJIANSHIBANLIBUFENBAOSONGSHIWUYAOPINJIXIZONGJUYAOSHENZHONGJIANDEYAOPINZHUCEBAOGAOCAILIAOZHONGYAOBAOCAI、YAOYONGFULIAODEZHENGSHIXINGWENJIANYINGBAOHANYIXIANEIRONGZHIYI:
（YI）YOUYONGDEYAOBAOCAI、YAOYONGFULIAOZHUCEZHENG；
（ER）ANBENGAOSUBUGAOQINGQIUSHIXIANJIEQIAGANXISHENPINGHOUHUODEDEYAOBAOCAI、YAOYONGFULIAOPIZHUNBIANHAO；
（SAN）ANBENGAOSUBUGAOQINGQIUSHISHIJIEQIAGANXIBAOGAODEYAOBAOCAI、YAOYONGFULIAO《SHOULIGAOSUSHU》。
WU、SHIWUYAOPINJIXIZONGJUYAOSHENZHONGJIANDUIYAOPINZHUCEQINGQIUJIQIJIEQIAGANXIBAOGAODEYAOBAOCAI、YAOYONGFULIAODEBAOGAOCAILIAOTINGZHIHUIZONG，BINGGENJU《YAOPINZHUCEBANLIFANGFA》DENGXIANGGANHUADINGZHANKAIJISHUSHENPING，XUYAOSHINENGGOUQINGQIUYAOPINZHUCEQINGQIURENHEYAOBAOCAI、YAOYONGFULIAOCHUCHANQIYEBUCHONGCAILIAO，BUCHONGCAILIAOSHIXIANAN《YAOPINZHUCEBANLIFANGFA》HUADINGLVXING。
LIU、YAOPINCHUCHANQINGQIUHUODEPIZHUNHOU，SHIWUYAOPINJIXIZONGJUYAOSHENZHONGJIANJIANGGAIYAOPINSUOJIEQIAGANXIBAOGAODEYAOBAOCAI、YAOYONGFULIAOXINXIGUIRUSHUJUKU，CIYUPIZHUNBIANHAO，FENGGAOQINGQIURENBINGZIDONGGONGRANXUYAODEXINXI。YAOPINCHUCHANQINGQIUBUYUPIZHUNDE，XIANGGAIYAOPINSUOJIEQIAGANXIBAOGAODEYAOBAOCAI、YAOYONGFULIAOQIYECHUJU《SHENPIDINGJIANGAOSUJIAN》，BINGSHENMINGLAIYOU。
QI、YAOPINZHUCEQINGQIURENGENJU《YAOPINZHUCEBANLIFANGFA》TICHU“BIANGECHUFANGZHONGYIYOUYAOYONGQINGQIUDEFULIAO”DEBUCHONGQINGQIUSHI，BIANGEHOUDEYAOYONGFULIAOHAIMEIYOUHUODEPIZHUNZHENGSHIWENJIANHUOPIZHUNBIANHAODE，KEGENJUBENGAOSUBUGAOQINGQIUYUGAIBUCHONGQINGQIUTINGZHIJIEQIAGANXIBAOGAO。
FANGZAOYAOPINZHIHELIAOXIAOFENQIXINGPINGGUZHONGXUYAOBIANGEYAOYONGFULIAOPINZHONGHUOGONGJISHANGDE，BIANGEHOUDEYAOYONGFULIAOHAIMEIYOUHUODEPIZHUNZHENGSHIWENJIANHUOPIZHUNBIANHAODE，KECANZHAOBENGAOSUBUGAOQINGQIU，YUFANGZAOYAOPINZHIHELIAOXIAOFENQIXINGPINGGUXIANGGANQINGQIUJIEQIAGANXIBAOGAO。
