秒速赛车控制器

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行政管理
12月1日起,全面實施藥品上市許可持有人制度,臨床試驗機構備案管理,取消藥品GMP、GSP認證
發布時間: 2019-12-01     來源: 國家藥監局

 

GUOJIAYAOJIANJUGUANYUGUANCHESHISHI《ZHONGHUARENMINGONGHEGUOYAOPINGUANLIFA》YOUGUANSHIXIANGDEGONGGAO(2019NIANDI103HAO)

《ZHONGHUARENMINGONGHEGUOYAOPINGUANLIFA》(YIXIACHENGYAOPINGUANLIFA)YIYOUDISHISANJIEQUANGUORENDACHANGWEIHUIDISHIERCIHUIYIYU2019NIAN8YUE26RIXIUDINGTONGGUO,ZI2019NIAN12YUE1RIQISHIXING。GUOJIAYAOJIANJUZHENGZAIZHUAJINKAIZHANPEITAOGUIZHANG、GUIFANXINGWENJIANHEJISHUZHINANDEZHIXIUDINGGONGZUO,BINGJIANGANCHENGXULUXUFABU。XIANJIUGUANCHESHISHIXINXIUDINGDEYAOPINGUANLIFAYOUGUANSHIXIANGGONGGAORUXIA:

一、關于藥品上市許可持有人制度

秒速赛车控制器XINXIUDINGDEYAOPINGUANLIFAQUANMIANSHISHIYAOPINSHANGSHIXUKECHIYOURENZHIDU。ZI2019NIAN12YUE1RIQI,FANCHIYOUYAOPINZHUCEZHENGSHU(YAOPINPIZHUNWENHAO、JINKOUYAOPINZHUCEZHENG、CHANPINZHUCEZHENG)DEQIYEHUOZHEYAOPINYANZHIJIGOUWEIYAOPINSHANGSHIXUKECHIYOUREN,YINGDANGYANGELVXINGYAOPINSHANGSHIXUKECHIYOURENYIWU,YIFADUIYAOPINYANZHI、SHENGCHAN、JINGYING、SHIYONGQUANGUOCHENGZHONGYAOPINDEANQUANXING、YOUXIAOXINGHEZHILIANGKEKONGXINGFUZE。

二、關于臨床試驗機構備案管理

ZI2019NIAN12YUE1RIQI,YAOWULINCHUANGSHIYANJIGOUSHISHIBEIANGUANLI。2019NIAN12YUE1RIYIQIANYIJINGSHOULISHANGWEIWANCHENGSHENPIDELINCHUANGSHIYANJIGOUZIGERENDINGSHENQING,BUZAIJIXUSHENPI,ANZHAOGUIDINGJINXINGBEIAN。

三、關于藥品GMP、GSP管理要求

秒速赛车控制器ZI2019NIAN12YUE1RIQI,QUXIAOYAOPINGMP、GSPRENZHENG,BUZAISHOULIGMP、GSPRENZHENGSHENQING,BUZAIFAFANGYAOPINGMP、GSPZHENGSHU。2019NIAN12YUE1RIYIQIANSHOULIDERENZHENGSHENQING,ANZHAOYUANYAOPINGMP、GSPRENZHENGYOUGUANGUIDINGBANLI。2019NIAN12YUE1RIQIANWANCHENGXIANCHANGJIANCHABINGFUHEYAOQIUDE,FAFANGYAOPINGMP、GSPZHENGSHU。FANXIANXINGFAGUIYAOQIUJINXINGXIANCHANGJIANCHADE,2019NIAN12YUE1RIHOUYINGDANGJIXUKAIZHANXIANCHANGJIANCHA,BINGJIANGXIANCHANGJIANCHAJIEGUOTONGZHIQIYE;JIANCHABUFUHEYAOQIUDE,ANZHAOGUIDINGYIFAYUYICHULI。

四、關于化學原料藥一并審評審批

秒速赛车控制器2019NIAN12YUE1RIQI,DUIHUAXUEYUANLIAOYAOBUZAIFAFANGYAOPINZHUCEZHENGSHU,YOUHUAXUEYUANLIAOYAOSHENGCHANQIYEZAIYUANFUBAODENGJIPINGTAISHANGDENGJI,SHIXINGYIBINGSHENPINGSHENPI。

五、關于藥品違法行為查處

秒速赛车控制器YAOPINYANZHI、SHENGCHAN、JINGYING、SHIYONGWEIFAXINGWEIFASHENGZAI2019NIAN12YUE1RIYIQIANDE,SHIYONGXIUDINGQIANDEYAOPINGUANLIFA,DANXINXIUDINGDEYAOPINGUANLIFABURENWEIWEIFAHUOZHECHUFAJIAOQINGDE,SHIYONGXINXIUDINGDEYAOPINGUANLIFA。WEIFAXINGWEIFASHENGZAI12YUE1RIYIHOUDE,SHIYONGXINXIUDINGDEYAOPINGUANLIFA。

GEJIYAOPINJIANGUANBUMENYAOJIANJUEGUANCHEYAOPINANQUAN“SIGEZUIYAN”YAOQIU,JIAQIANGXINXIUDINGDEYAOPINGUANLIFADEXUANCHUANGUANCHEGONGZUO,JINYIBUJIADAJIANDUJIANCHALIDU,DUCUQIYESHENGCHANJINGYINGXINGWEICHIXUHEGUI,YIFAYANLICHACHUGELEIWEIFAWEIGUIXINGWEI,QIESHIWEIHUGUANGDARENMINQUNZHONGYONGYAOANQUAN。

TECIGONGGAO。

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秒速赛车控制器2019NIAN11YUE29RI

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