醫(yī)療器械注冊使用境外臨床試驗數(shù)據(jù)的基本原則

test4

　　為了避免或減少申請人通過醫(yī)療器械境外臨床試驗數(shù)據(jù)申報注冊過程中重復性臨床試驗，加快醫(yī)療器械在我國上市進程，國家食品藥品監(jiān)督管理總局組織制定了接受醫(yī)療器械境外臨床試驗數(shù)據(jù)技術指導原則。其中涉及的境外臨床試驗數(shù)據(jù)是指，全部或同期在境外具備臨床試驗開展所在國家（地區(qū)）要求條件的臨床試驗機構中，對擬在我國申報注冊的醫(yī)療器械在正常使用條件下的安全有效性進行確認的過程中所產(chǎn)生的研究數(shù)據(jù)，需要符合下列基本原則。

　　一、倫理原則

　　境外臨床試驗應當遵循《世界醫(yī)學大會赫爾辛基宣言》確定的倫理準則。申請人同時需說明采用的臨床試驗開展所在國家（地區(qū)）的倫理、法律、法規(guī)所制定的規(guī)范和標準，或國際規(guī)范和標準。

　　二、依法原則

　　境外臨床試驗應當在有臨床試驗質量管理的國家（地區(qū)）開展，并且符合我國醫(yī)療器械（含體外診斷試劑）臨床試驗監(jiān)管要求，若臨床試驗所符合的臨床試驗質量管理文件與《醫(yī)療器械臨床試驗質量管理規(guī)范》（GCP）有差異，應詳細說明差異內容，并充分證明差異內容不影響研究結果的真實性、科學性、可靠性及可追溯性，且能夠保障受試者權益。申請人及臨床試驗機構應接受國家食品藥品監(jiān)督管理總局的監(jiān)督檢查。

　　三、科學原則

　　境外臨床試驗數(shù)據(jù)應真實、科學、可靠、可追溯，申請人應提供完整的試驗數(shù)據(jù)，不得篩選。而且申請人應確保在境外開展的臨床試驗目的適當，試驗設計科學合理，試驗結論清晰，受試者的權益得到保障，其他人員可能遭受的風險得以保護。

ohnfb

頂一個先吧

oiokd

http://www.longyin.net/thread-3801089-1-3.html
http://www.longyin.net/thread-3801090-1-3.html
http://www.longyin.net/thread-3801091-1-3.html
http://www.longyin.net/thread-3801092-1-3.html
http://www.longyin.net/thread-3801093-1-3.html
http://www.longyin.net/thread-3801094-1-3.html
http://www.longyin.net/thread-3801095-1-3.html
http://www.longyin.net/thread-3801096-1-3.html
http://www.longyin.net/thread-3801097-1-3.html
http://www.longyin.net/thread-3801098-1-3.html
http://www.longyin.net/thread-3801099-1-3.html
http://www.longyin.net/thread-3801100-1-3.html
http://www.longyin.net/thread-3801101-1-3.html
http://www.longyin.net/thread-3801102-1-3.html
http://www.longyin.net/thread-3801103-1-3.html
http://www.longyin.net/thread-3801105-1-3.html
http://www.longyin.net/thread-3801106-1-3.html
http://www.longyin.net/thread-3801107-1-3.html
http://www.longyin.net/thread-3801129-1-3.html
http://www.longyin.net/thread-3801130-1-3.html
http://www.longyin.net/thread-3801284-1-3.html
http://www.longyin.net/thread-3801285-1-3.html
http://www.longyin.net/thread-3801286-1-3.html
http://www.longyin.net/thread-3801287-1-3.html
http://www.longyin.net/thread-3801288-1-3.html
http://www.longyin.net/thread-3801289-1-3.html
http://www.longyin.net/thread-3801290-1-3.html
http://www.longyin.net/thread-3801291-1-3.html
http://www.longyin.net/thread-3801292-1-3.html
http://www.longyin.net/thread-3801293-1-3.html
http://www.longyin.net/thread-3801294-1-3.html
http://www.longyin.net/thread-3801295-1-3.html
http://www.longyin.net/thread-3801297-1-3.html
http://www.longyin.net/thread-3801300-1-3.html
http://www.longyin.net/thread-3801302-1-3.html
http://www.longyin.net/thread-3801303-1-3.html
http://www.longyin.net/thread-3801305-1-3.html
http://www.longyin.net/thread-3801307-1-3.html
http://www.longyin.net/thread-3801309-1-3.html
http://www.longyin.net/thread-3801311-1-3.html
http://www.longyin.net/thread-3801313-1-2.html
http://www.longyin.net/thread-3801315-1-2.html
http://www.longyin.net/thread-3801317-1-2.html
http://www.longyin.net/thread-3801318-1-2.html
http://www.longyin.net/thread-3801320-1-2.html
http://www.longyin.net/thread-3801322-1-2.html
http://www.longyin.net/thread-3801324-1-2.html
http://www.longyin.net/thread-3801326-1-2.html
http://www.longyin.net/thread-3801328-1-2.html
http://www.longyin.net/thread-3801330-1-2.html
http://www.longyin.net/thread-3801332-1-2.html
http://www.longyin.net/thread-3801336-1-2.html
http://www.longyin.net/thread-3801338-1-2.html
http://www.longyin.net/thread-3801340-1-2.html
http://www.longyin.net/thread-3801342-1-2.html
http://www.longyin.net/thread-3801344-1-2.html
http://www.longyin.net/thread-3801346-1-2.html
http://www.longyin.net/thread-3801348-1-2.html
http://www.longyin.net/thread-3801350-1-2.html
http://www.longyin.net/thread-3801352-1-2.html
http://www.longyin.net/thread-3801354-1-2.html
http://www.longyin.net/thread-3801356-1-2.html
http://www.longyin.net/thread-3801358-1-2.html
http://www.longyin.net/thread-3801361-1-2.html
http://www.longyin.net/thread-3801363-1-2.html
http://www.longyin.net/thread-3801365-1-2.html
http://www.longyin.net/thread-3801367-1-2.html
http://www.longyin.net/thread-3801369-1-2.html
http://www.longyin.net/thread-3801372-1-2.html
http://www.longyin.net/thread-3801374-1-2.html
http://www.longyin.net/thread-3801376-1-2.html
http://www.longyin.net/thread-3801378-1-2.html
http://www.longyin.net/thread-3801380-1-2.html
http://www.longyin.net/thread-3801382-1-2.html
http://www.longyin.net/thread-3801384-1-2.html
http://www.longyin.net/thread-3801386-1-2.html
http://www.longyin.net/thread-3801388-1-2.html
http://www.longyin.net/thread-3801390-1-2.html
http://www.longyin.net/thread-3801392-1-2.html
http://www.longyin.net/thread-3801395-1-2.html
http://www.longyin.net/thread-3801397-1-1.html
http://www.longyin.net/thread-3801399-1-1.html
http://www.longyin.net/thread-3801402-1-1.html
http://www.longyin.net/thread-3801404-1-1.html
http://www.longyin.net/thread-3801406-1-1.html
http://www.longyin.net/thread-3801408-1-1.html
http://www.longyin.net/thread-3801410-1-1.html
http://www.longyin.net/thread-3801413-1-1.html
http://www.longyin.net/thread-3801415-1-1.html
http://www.longyin.net/thread-3801417-1-1.html
http://www.longyin.net/thread-3801419-1-1.html
http://www.longyin.net/thread-3801421-1-1.html
http://www.longyin.net/thread-3801423-1-1.html
http://www.longyin.net/thread-3801425-1-1.html
http://www.longyin.net/thread-3801427-1-1.html
http://www.longyin.net/thread-3801430-1-1.html
http://www.longyin.net/thread-3801432-1-1.html
http://www.longyin.net/thread-3801434-1-1.html
http://www.longyin.net/thread-3801436-1-1.html
http://www.longyin.net/thread-3801438-1-1.html
http://www.longyin.net/thread-3801440-1-1.html
http://www.longyin.net/thread-3801442-1-1.html
http://www.longyin.net/thread-3801444-1-1.html
http://www.longyin.net/thread-3801446-1-1.html
http://www.longyin.net/thread-3801448-1-1.html
http://www.longyin.net/thread-3801450-1-1.html
http://www.longyin.net/thread-3801452-1-1.html
http://www.longyin.net/thread-3801454-1-1.html
http://www.longyin.net/thread-3801456-1-1.html
http://www.longyin.net/thread-3801458-1-1.html
http://www.longyin.net/thread-3801460-1-1.html
http://www.longyin.net/thread-3801462-1-1.html
http://www.longyin.net/thread-3801464-1-1.html
http://www.longyin.net/thread-3801466-1-1.html
http://www.longyin.net/thread-3801468-1-1.html
http://www.longyin.net/thread-3801476-1-1.html
http://www.longyin.net/thread-3801478-1-1.html
http://www.longyin.net/thread-3801480-1-1.html
http://www.longyin.net/thread-3801482-1-1.html
http://www.longyin.net/thread-3801484-1-1.html

oiokd

http://www.yjsqsn.com/bazisuanming/3386.html
http://www.yjsqsn.com/bazisuanming/3387.html
http://www.zqxszx.com/lianxi/302.html
http://www.zqxszx.com/lianxi/303.html
https://www.03ky.com/bbs-3693-1-1.html

o拼多多券商城k

♀騙販子團隊
騙子QQ723323134,騙子微信kkk111223
845725254
67537346
1336510365
820112280
723323134
505761913
微信 k91551
464250413
766481639
547625716
582668028
770037091

拼多多優(yōu)惠券商城 全場都有券

免拼團 一個也拼的拼多多

自己搜索好貨

電腦端入口http://www.wz10086.top保存下圖手機版入口二維碼防走丟

www.pinduoduo10086.xyz
www.sihu45.online
www.weixinqun.online
www.youhuiquan.我愛你

www.youhuiquan.xn--6qq986b3xl

q拼多多券商城j

◎騙販子團隊
騙子QQ723323134,騙子微信kkk111223
845725254
67537346
1336510365
820112280
723323134
505761913
微信 k91551
464250413
766481639
547625716
582668028
770037091

拼多多優(yōu)惠券商城 全場都有券

免拼團 一個也拼的拼多多

自己搜索好貨

電腦端入口http://www.wz10086.top保存下圖手機版入口二維碼防走丟

www.pinduoduo10086.xyz
www.sihu45.online
www.weixinqun.online
www.youhuiquan.我愛你

www.youhuiquan.xn--6qq986b3xl

vvsqw

哪里有出售純冰頭子小果子QQ913613462 武哥
長期出售高/純度鉆石黃白牙簽冰糖果丸子性用品
純/冰小果子白冰豬肉QQ913613462,冰
(植 物 冰)350一克(白黃牙簽)250一克
QQ913613462 武哥，質量保證，非誠勿擾！誠意合作聯(lián)系手機
哪里有出售豬肉冰糖牙簽果子4號鉆石 QQ913613462純冰出售

澳門生活網(wǎng)b

知道了 不錯~~~













淘客機器人、淘客返利機器人、淘寶客機器人 聯(lián)系客服QQ：4000017854

定洲備

真不錯，贊一個，繼續(xù)努力啊












本站發(fā)布紅包，見者有份！

每人每天都可免費領取一次！

test4

smlqf3 發(fā)表于 2018-9-8 00:52
好貼阿樓主，代表大家謝謝您

smlqf3

好貼阿樓主，代表大家謝謝您











自薦信   http://www.gfgfgf.com.tw/mzyy/   2018年09月08日 簡歷製作
中醫(yī)五穀雜糧養(yǎng)生    謎語大全 http://www.gfgfgf.com.tw/zyxx/ycsc/  個性髮型   中醫(yī)男性       http://www.gfgfgf.com.tw/zybj/nxbj/  節(jié)日祝福語