醫(yī)療器械注冊(cè)使用境外臨床試驗(yàn)數(shù)據(jù)的基本原則

test4

　　為了避免或減少申請(qǐng)人通過(guò)醫(yī)療器械境外臨床試驗(yàn)數(shù)據(jù)申報(bào)注冊(cè)過(guò)程中重復(fù)性臨床試驗(yàn)，加快醫(yī)療器械在我國(guó)上市進(jìn)程，國(guó)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(yàn)數(shù)據(jù)技術(shù)指導(dǎo)原則。其中涉及的境外臨床試驗(yàn)數(shù)據(jù)是指，全部或同期在境外具備臨床試驗(yàn)開展所在國(guó)家（地區(qū)）要求條件的臨床試驗(yàn)機(jī)構(gòu)中，對(duì)擬在我國(guó)申報(bào)注冊(cè)的醫(yī)療器械在正常使用條件下的安全有效性進(jìn)行確認(rèn)的過(guò)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(yàn)應(yīng)當(dāng)遵循《世界醫(yī)學(xué)大會(huì)赫爾辛基宣言》確定的倫理準(zhǔn)則。申請(qǐng)人同時(shí)需說(shuō)明采用的臨床試驗(yàn)開展所在國(guó)家（地區(qū)）的倫理、法律、法規(guī)所制定的規(guī)范和標(biāo)準(zhǔn)，或國(guó)際規(guī)范和標(biāo)準(zhǔn)。

　　二、依法原則

　　境外臨床試驗(yàn)應(yīng)當(dāng)在有臨床試驗(yàn)質(zhì)量管理的國(guó)家（地區(qū)）開展，并且符合我國(guó)醫(yī)療器械（含體外診斷試劑）臨床試驗(yàn)監(jiān)管要求，若臨床試驗(yàn)所符合的臨床試驗(yàn)質(zhì)量管理文件與《醫(yī)療器械臨床試驗(yàn)質(zhì)量管理規(guī)范》（GCP）有差異，應(yīng)詳細(xì)說(shuō)明差異內(nèi)容，并充分證明差異內(nèi)容不影響研究結(jié)果的真實(shí)性、科學(xué)性、可靠性及可追溯性，且能夠保障受試者權(quán)益。申請(qǐng)人及臨床試驗(yàn)機(jī)構(gòu)應(yīng)接受國(guó)家食品藥品監(jiān)督管理總局的監(jiān)督檢查。

　　三、科學(xué)原則

　　境外臨床試驗(yàn)數(shù)據(jù)應(yīng)真實(shí)、科學(xué)、可靠、可追溯，申請(qǐng)人應(yīng)提供完整的試驗(yàn)數(shù)據(jù)，不得篩選。而且申請(qǐng)人應(yīng)確保在境外開展的臨床試驗(yàn)?zāi)康倪m當(dāng)，試驗(yàn)設(shè)計(jì)科學(xué)合理，試驗(yàn)結(jié)論清晰，受試者的權(quán)益得到保障，其他人員可能遭受的風(fēng)險(xiǎn)得以保護(hù)。

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smlqf3 發(fā)表于 2018-9-8 00:52
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自薦信   http://www.gfgfgf.com.tw/mzyy/   2018年09月08日 簡(jiǎn)歷製作
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