凯发app

  • 法律法规

药物临床试验机构管理规定

发布时间 : 2020-02-26 12:27 点击次数 :

YAOWULINCHUANGSHIYANJIGOUGUANLIGUIDING

  第一章 总 则

凯发app   DIYITIAO WEIJIAQIANGYAOWULINCHUANGSHIYANJIGOUDEJIANDUGUANLI,GENJU《ZHONGHUARENMINGONGHEGUOYAOPINGUANLIFA》《ZHONGHUARENMINGONGHEGUOYIMIAOGUANLIFA》《ZHONGHUARENMINGONGHEGUOYAOPINGUANLIFASHISHITIAOLI》《YILIAOJIGOUGUANLITIAOLI》,YIJIZHONGGONGZHONGYANGBANGONGTING、GUOWUYUANBANGONGTING《KAIFAappSHENHUASHENPINGSHENPIZHIDUGAIGEGULIYAOPINYILIAOQIXIECHUANGXINDEYIJIAN》,ZHIDINGBENGUIDING。

  DIERTIAO YAOWULINCHUANGSHIYANJIGOUSHIZHIJUBEIXIANGYINGTIAOJIAN,ANZHAO《YAOWULINCHUANGSHIYANZHILIANGGUANLIGUIFAN》(GCP)HEYAOWULINCHUANGSHIYANXIANGGUANJISHUZHIDAOYUANZEDENGYAOQIU,KAIZHANYAOWULINCHUANGSHIYANDEJIGOU。

  DISANTIAO CONGSHIYAOPINYANZHIHUODONG,ZAIZHONGHUARENMINGONGHEGUOJINGNEIKAIZHANJINGGUOJIAYAOPINJIANDUGUANLIJUPIZHUNDEYAOWULINCHUANGSHIYAN(BAOKUOBEIANHOUKAIZHANDESHENGWUDENGXIAOXINGSHIYAN),YINGDANGZAIYAOWULINCHUANGSHIYANJIGOUZHONGJINXING。YAOWULINCHUANGSHIYANJIGOUYINGDANGFUHEBENGUIDINGTIAOJIAN,SHIXINGBEIANGUANLI。JINKAIZHANYUYAOWULINCHUANGSHIYANXIANGGUANDESHENGWUYANGBENDENGFENXIDEJIGOU,WUXUBEIAN。

  DISITIAO YAOPINJIANDUGUANLIBUMEN、WEISHENGJIANKANGZHUGUANBUMENGENJUGEZIZHIZEFUZEYAOWULINCHUANGSHIYANJIGOUDEJIANDUGUANLIGONGZUO。

  第二章 条件和备案

凯发app   DIWUTIAO YAOWULINCHUANGSHIYANJIGOUYINGDANGJUBEIDEJIBENTIAOJIANBAOKUO:

凯发app   (YI)JUYOUYILIAOJIGOUZHIYEXUKEZHENG,JUYOUERJIJIADENGYISHANGZIZHI,SHIYANCHANGDIYINGDANGFUHESUOZAIQUYUWEISHENGJIANKANGZHUGUANBUMENDUIYUANQU(CHANGDI)GUANLIGUIDING。KAIZHANYIHUANZHEWEISHOUSHIZHEDEYAOWULINCHUANGSHIYANDEZHUANYEYINGDANGYUYILIAOJIGOUZHIYEXUKEDEZHENLIAOKEMUXIANGYIZHI。KAIZHANJIANKANGSHOUSHIZHEDEⅠQIYAOWULINCHUANGSHIYAN、SHENGWUDENGXIAOXINGSHIYANYINGDANGWEIⅠQILINCHUANGSHIYANYANJIUSHIZHUANYE;

  (ER)JUYOUYUKAIZHANYAOWULINCHUANGSHIYANXIANGSHIYINGDEZHENLIAOJISHUNENGLI;

凯发app   (SAN)JUYOUYUYAOWULINCHUANGSHIYANXIANGSHIYINGDEDULIDEGONGZUOCHANGSUO、DULIDELINCHUANGSHIYANYONGYAOFANG、DULIDEZILIAOSHI,YIJIBIYAODESHEBEISHESHI;

凯发app   (SI)JUYOUZHANGWOYAOWULINCHUANGSHIYANJISHUYUXIANGGUANFAGUI,NENGCHENGDANYAOWULINCHUANGSHIYANDEYANJIURENYUAN;QIZHONGZHUYAOYANJIUZHEYINGDANGJUYOUGAOJIZHICHENGBINGCANJIAGUO3GEYISHANGYAOWULINCHUANGSHIYAN;

凯发app   (WU)KAIZHANYAOWULINCHUANGSHIYANDEZHUANYEJUYOUYUCHENGDANYAOWULINCHUANGSHIYANXIANGSHIYINGDECHUANGWEISHU、MENJIZHENLIANG;

  (LIU)JUYOUJIWEIZHONGBINGZHENGQIANGJIUDESHESHISHEBEI、RENYUANYUCHUZHINENGLI;

  (QI)JUYOUCHENGDANYAOWULINCHUANGSHIYANZUZHIGUANLIDEZHUANMENBUMEN;

凯发app   (BA)JUYOUYUKAIZHANYAOWULINCHUANGSHIYANXIANGSHIYINGDEYIJIKESHI,WEITUOYIXUEJIANCEDECHENGDANJIGOUYINGDANGJUBEIXIANGYINGZIZHI;

  (JIU)JUYOUFUZEYAOWULINCHUANGSHIYANLUNLISHENCHADELUNLIWEIYUANHUI;

凯发app   (SHI)JUYOUYAOWULINCHUANGSHIYANGUANLIZHIDUHEBIAOZHUNCAOZUOGUICHENG;

凯发app   (SHIYI)JUYOUFANGFANHECHULIYAOWULINCHUANGSHIYANZHONGTUFASHIJIANDEGUANLIJIZHIYUCUOSHI;

凯发app   (SHIER)WEISHENGJIANKANGZHUGUANBUMENGUIDINGDEYIWURENYUANGUANLI、CAIWUGUANLIDENGQITATIAOJIAN。

凯发app   YAOWULINCHUANGSHIYANJIGOUWEIJIBINGYUFANGKONGZHIJIGOUDE,YINGDANGWEISHENGJIYISHANGJIBINGYUFANGKONGZHIJIGOU,BUYAOQIUBENTIAOQIANKUANDIYIXIANG、DIWUXIANG、DILIUXIANGTIAOJIAN。

凯发app   DILIUTIAO GUOJIAYAOPINJIANDUGUANLIBUMENFUZEJIANLI“YAOWULINCHUANGSHIYANJIGOUBEIANGUANLIXINXIPINGTAI”(JIANCHENGBEIANPINGTAI),YONGYUYAOWULINCHUANGSHIYANJIGOUDENGJIBEIANHEYUNXINGGUANLI,YIJIYAOPINJIANDUGUANLIBUMENHEWEISHENGJIANKANGZHUGUANBUMENJIANDUJIANCHADEXINXILURU、GONGXIANGHEGONGKAI。

  DIQITIAO YAOWULINCHUANGSHIYANJIGOUYINGDANGZIXINGHUOZHEPINQINGDISANFANGDUIQILINCHUANGSHIYANJIGOUJIZHUANYEDEJISHUSHUIPING、SHESHITIAOJIANJITEDIANJINXINGPINGGU,PINGGUFUHEBENGUIDINGYAOQIUHOUBEIAN。

凯发app   DIBATIAO YAOWULINCHUANGSHIYANJIGOUANZHAOBEIANPINGTAIYAOQIUZHUCEJIGOUYONGHU,WANCHENGJIBENXINXIBIAOTIANXIE,TIJIAOYILIAOJIGOUZHIYEXUKEZHENGDENGBEIANTIAOJIANDEZIZHIZHENGMINGWENJIAN,JINGBEIANPINGTAISHENHETONGGUOHOUJIHUOZHANGHAO,ANZHAOBEIANPINGTAIYAOQIUTIANXIEZUZHIGUANLIJIAGOU、SHEBEISHESHI、YANJIURENYUAN、LINCHUANGSHIYANZHUANYE、LUNLIWEIYUANHUI、BIAOZHUNCAOZUOGUICHENGDENGBEIANXINXI,SHANGCHUANPINGGUBAOGAO,BEIANPINGTAIJIANGZIDONGSHENGCHENGBEIANHAO。

  BEIANDEYAOWULINCHUANGSHIYANJIGOUZENGJIALINCHUANGSHIYANZHUANYE,YINGDANGXINGCHENGXINZENGZHUANYEPINGGUBAOGAO,ANZHAOBEIANPINGTAIYAOQIUTIANLUXIANGGUANXINXIJISHANGCHUANPINGGUBAOGAO。

  SHENGJIYISHANGJIBINGYUFANGKONGZHIJIGOUKELINXUANHEPINGGUSHUDIJUBEIYIMIAOYUFANGJIEZHONGZIZHIDEJIGOUZUOWEISHIYANXIANCHANGDANWEI,ZAIBEIANPINGTAISHANGJINXINGDENGJIBEIAN,SHIYANXIANCHANGDANWEICANZHAOLINCHUANGSHIYANZHUANYEGUANLI。

  DIJIUTIAO YAOWULINCHUANGSHIYANJIGOUDUIZAIBEIANPINGTAISUOTIANXIEXINXIDEZHENSHIXINGHEZHUNQUEXINGCHENGDANQUANBUFALVZEREN。BEIANDEYAOWULINCHUANGSHIYANJIGOUMINGCHENG、DIZHI、LIANXIREN、LIANXIFANGSHIHELINCHUANGSHIYANZHUANYE、ZHUYAOYANJIUZHEDENGJIBENXINXIXIANGSHEHUIGONGKAI,JIESHOUGONGZHONGDECHAYUE、JIANDU。

凯发app   DISHITIAO YAOWULINCHUANGSHIYANJIGOUMINGCHENG、JIGOUDIZHI、JIGOUJIBIE、JIGOUFUZERENYUAN、LUNLIWEIYUANHUIHEZHUYAOYANJIUZHEDENGBEIANXINXIFASHENGBIANHUASHI,YAOWULINCHUANGSHIYANJIGOUYINGDANGYU5GEGONGZUORINEIZAIBEIANPINGTAIZHONGANYAOQIUTIANXIEBINGTIJIAOBIANGENGQINGKUANG。

  第三章 运行管理

凯发app   DISHIYITIAO YAOWULINCHUANGSHIYANJIGOUBEIANHOU,YINGDANGANZHAOXIANGGUANFALVFAGUIHE《YAOWULINCHUANGSHIYANZHILIANGGUANLIGUIFAN》YAOQIU,ZAIBEIANDIZHIHEXIANGYINGZHUANYENEIKAIZHANYAOWULINCHUANGSHIYAN,QUEBAOYANJIUDEKEXUEXING,FUHELUNLI,QUEBAOYANJIUZILIAODEZHENSHIXING、ZHUNQUEXING、WANZHENGXING,QUEBAOYANJIUGUOCHENGKEZHUISUXING,BINGCHENGDANXIANGYINGFALVZEREN。JIBINGYUFANGKONGZHIJIGOUKAIZHANYIMIAOLINCHUANGSHIYAN,YINGDANGFUHEYIMIAOLINCHUANGSHIYANZHILIANGGUANLIXIANGGUANZHIDAOYUANZE,YOUBEIANDESHENGJIYISHANGJIBINGYUFANGKONGZHIJIGOUFUZEYAOWULINCHUANGSHIYANDEGUANLI,BINGCHENGDANZHUYAOFALVZEREN;SHIYANXIANCHANGDANWEICHENGDANZHIJIEFALVZEREN。

凯发app   DISHIERTIAO YAOWULINCHUANGSHIYANJIGOUSHELIHUOZHEZHIDINGDEYAOWULINCHUANGSHIYANZUZHIGUANLIZHUANMENBUMEN,TONGCHOUYAOWULINCHUANGSHIYANDELIXIANGGUANLI、SHIYANYONGYAOPINGUANLI、ZILIAOGUANLI、ZHILIANGGUANLIDENGXIANGGUANGONGZUO,CHIXUTIGAOYAOWULINCHUANGSHIYANZHILIANG。

  DISHISANTIAO YAOWULINCHUANGSHIYANJIGOUSHIYAOWULINCHUANGSHIYANZHONGSHOUSHIZHEQUANYIBAOHUDEZERENZHUTI。LUNLIWEIYUANHUIFUZESHENCHAYAOWULINCHUANGSHIYANFANGANDEKEXUEXINGHELUNLIHELIXING,SHENHEHEJIANDUYAOWULINCHUANGSHIYANYANJIUZHEDEZIZHI,JIANDUYAOWULINCHUANGSHIYANKAIZHANQINGKUANG,BAOZHENGLUNLISHENCHAGUOCHENGDULI、KEGUAN、GONGZHENG。LUNLIWEIYUANHUIYINGDANGANZHAO《SHEJIRENDESHENGWUYIXUEYANJIULUNLISHENCHABANFA》YAOQIUZAIYIXUEYANJIUDENGJIBEIANXINXIXITONGGONGKAIYOUGUANXINXI,JIESHOUBENJIGOUHEWEISHENGJIANKANGZHUGUANBUMENDEGUANLIHEGONGZHONGJIANDU。

  DISHISITIAO ZHUYAOYANJIUZHEYINGDANGJIANDUYAOWULINCHUANGSHIYANSHISHIJIGEYANJIURENYUANLVXINGQIGONGZUOZHIZEDEQINGKUANG,BINGCAIQUCUOSHISHISHIYAOWULINCHUANGSHIYANDEZHILIANGGUANLI,QUEBAOSHUJUDEKEKAO、ZHUNQUE。

  DISHIWUTIAO XINYAOⅠQILINCHUANGSHIYANHUOZHELINCHUANGFENGXIANJIAOGAOXUYAOLINCHUANGMIQIEJIANCEDEYAOWULINCHUANGSHIYAN,YINGDANGYOUSANJIYILIAOJIGOUSHISHI。YIMIAOLINCHUANGSHIYANYINGDANGYOUSANJIYILIAOJIGOUHUOZHESHENGJIYISHANGJIBINGYUFANGKONGZHIJIGOUSHISHIHUOZHEZUZHISHISHI。ZHUCESHENQINGRENWEITUOBEIANDEYAOWULINCHUANGSHIYANJIGOUKAIZHANYAOWULINCHUANGSHIYAN,KEZIXINGHUOZHEPINQINGDISANFANGDUIWEITUODEYAOWULINCHUANGSHIYANJIGOUJINXINGPINGGU。

凯发app   DISHILIUTIAO YAOWULINCHUANGSHIYANJIGOUYINGDANGYUMEINIAN1YUE31RIQIANZAIBEIANPINGTAITIANBAOSHANGYINIANDUKAIZHANYAOWULINCHUANGSHIYANGONGZUOZONGJIEBAOGAO。

  DISHIQITIAO YAOWULINCHUANGSHIYANJIGOUJIEDAOJINGWAIYAOPINJIANDUGUANLIBUMENJIANCHAYAOWULINCHUANGSHIYANYAOQIUDE,YINGDANGZAIJIESHOUJIANCHAQIANJIANGXIANGGUANXINXILURUBEIANPINGTAI,BINGZAIJIEDAOJIANCHAJIEGUOHOU5GEGONGZUORINEIJIANGJIANCHAJIEGUOXINXILURUBEIANPINGTAI。

  第四章 监督检查

  DISHIBATIAO GUOJIAYAOPINJIANDUGUANLIJUHUITONGGUOJIAWEISHENGJIANKANGWEIJIANLIYAOWULINCHUANGSHIYANJIGOUGUOJIAJIANCHAYUANKU,GENJUJIANGUANHESHENPINGXUYAO,YIJUZHIZEDUIYAOWULINCHUANGSHIYANJIGOUJINXINGJIANDUJIANCHA。

  DISHIJIUTIAO SHENGJIYAOPINJIANDUGUANLIBUMEN、SHENGJIWEISHENGJIANKANGZHUGUANBUMENGENJUYAOWULINCHUANGSHIYANJIGOUZIWOPINGGUQINGKUANG、KAIZHANYAOWULINCHUANGSHIYANQINGKUANG、JIWANGJIANDUJIANCHAQINGKUANGDENG,YIJUZHIZEZUZHIDUIBENXINGZHENGQUYUNEIYAOWULINCHUANGSHIYANJIGOUKAIZHANRICHANGJIANDUJIANCHA。DUIYUXINBEIANDEYAOWULINCHUANGSHIYANJIGOUHUOZHEZENGJIALINCHUANGSHIYANZHUANYE、DIZHIBIANGENGDE,YINGDANGZAI60GEGONGZUORINEIKAIZHANSHOUCIJIANDUJIANCHA。

凯发app   DIERSHITIAO YAOWULINCHUANGSHIYANJIGOUWEIZUNSHOU《YAOWULINCHUANGSHIYANZHILIANGGUANLIGUIFAN》DE,YIZHAO《YAOPINGUANLIFA》DIYIBAIERSHILIUTIAOGUIDINGCHUFA。

  DIERSHIYITIAO YAOWULINCHUANGSHIYANJIGOUWEIANZHAOBENGUIDINGBEIANDE,GUOJIAYAOPINJIANDUGUANLIBUMENBUJIESHOUQIWANCHENGDEYAOWULINCHUANGSHIYANSHUJUYONGYUYAOPINXINGZHENGXUKE。

凯发app   DIERSHIERTIAO WEIFANBENGUIDING,YINMANZHENSHIQINGKUANG、CUNZAIZHONGDAYILOU、TIGONGWUDAOXINGHUOZHEXUJIAXINXIHUOZHECAIQUQITAQIPIANSHOUDUANQUDEBEIANDE,YIJICUNZAIQUEXIANBUSHIYIJIXUCHENGDANYAOWULINCHUANGSHIYANDE,QUXIAOQIYAOWULINCHUANGSHIYANJIGOUHUOZHEXIANGGUANLINCHUANGSHIYANZHUANYEDEBEIAN,YIFACHULI。

凯发app   DIERSHISANTIAO SHENGJIYISHANGYAOPINJIANDUGUANLIBUMEN、SHENGJIYISHANGWEISHENGJIANKANGZHUGUANBUMENDUIYAOWULINCHUANGSHIYANJIGOUJIANDUJIANCHAJIEGUOJICHULIQINGKUANG,YINGDANGJISHILURUBEIANPINGTAIBINGXIANGSHEHUIGONGBU。

  第五章 附 则

  DIERSHISITIAO YAOWULINCHUANGSHIYANJIGOUBEIANHAOGESHIWEI: YAOLINJIGOUBEI+4WEINIANDAIHAO+5WEISHUNXUBIANHAO。

  DIERSHIWUTIAO ZHONGYANGJUNWEIHOUQINBAOZHANGBUWEISHENGJU、ZHONGGUORENMINWUZHUANGJINGCHABUDUIHOUQINBUWEISHENGJUFENBIEDUIJUNDUI、WUJINGSUOSHUYAOWULINCHUANGSHIYANJIGOU,LVXINGBENGUIDINGZHONGSHENGJIYAOPINJIANDUGUANLIBUMENHEWEISHENGJIANKANGZHUGUANBUMENDEJIANDUJIANCHAZHIZE。

  DIERSHILIUTIAO DUIJIEDUDENGTESHUYAOWUXUZAITEDINGJIGOUKAIZHANYAOWULINCHUANGSHIYAN,YINGDANGJUYOUXIANGYINGYEWUZHUGUANBUMENFAFANGDEJIGOUZIZHI,CANZHAOBENGUIDINGGUANLI。

凯发app   DIERSHIQITIAO YAOPINJIANDUGUANLIBUMEN、WEISHENGJIANKANGZHUGUANBUMENDUIYUYAOWULINCHUANGSHIYANJIGOUBEIANHEJIANDUJIANCHA,BUSHOUQUFEIYONG。

  DIERSHIBATIAO BENGUIDINGZI2019NIAN12YUE1RIQISHIXING。《YAOWULINCHUANGSHIYANJIGOUZIGERENDINGBANFA(SHIXING)》(GUOSHIYAOJIANAN〔2004〕44HAO)、《KAIFAappKAIZHANYAOWULINCHUANGSHIYANJIGOUZIGERENDINGFUHEJIANCHAGONGZUODETONGZHI》(GUOSHIYAOJIANZHU〔2009〕203HAO)HE《KAIFAappYINFAYICIXINGYIMIAOLINCHUANGSHIYANJIGOUZIGERENDINGGUANLIGUIDINGDETONGZHI》(SHIYAOJIANYAOHUAGUAN〔2013〕248HAO)TONGSHIFEIZHI。