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总局对于药包材药用辅料与药品接洽干系审评审批有关事变的告诉布告(2016 年第 134 号)

2021-12-10

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。

ZAIYISHANGSHIYAOPINZHONGHANQINGXIANGYANDEQIYUHESHIYAOYONGQINGQIUDEYAOYONGFULIAO,KECHIXUZAIYUANYAOPINZHONGXIANGYAN。DANYONGYUQIYUYAOPINDEYAOWULINCHUANGSHIYANQINGQIUHUOCHUCHANQINGQIUSHI,YINGANBENGAOSUBUGAOQINGQIUBAOSONGXIANGGANCAILIAO。

LIU、YAOBAOCAI、YAOYONGFULIAOCHUCHANQIYEYINGDACHANWUPINZHIDANREN;YINGZAIZHIZUXIANGYINGCHUCHANWUZHIBANLIQINGQIUDEQIANTIXIAGOUZAOCHUCHAN;YINGGONGTONGYAOPINCHUCHANQIYEZHANKAIGONGJISHANGSHENJI。

QI、YAOPINZHUCEQINGQIURENYINGQUEBAOSUOLIYONGYAOBAOCAI、YAOYONGFULIAOHESHIYAOYONGQINGQIU;YINGZENGQIANGYAOBAOCAI、YAOYONGFULIAOGONGJISHANGSHENJI;YINGSHISHIBAWOYAOBAOCAI、YAOYONGFULIAODEBIANGEHUANJING,BINGDUIBIANGEDAILAIDEYINGXIANGTINGZHIYANTAOHEPINGGU,GENJU《YAOPINZHUCEBANLIFANGFA》DENGYOUGUANHUADINGXIANGSHIWUYAOPINJIANSHIBANLIBUFENTIJIAOXIANGYINGDEBUCHONGQINGQIU。

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

 22.PNG

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。





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