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(shù)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(gòu)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(yīng)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(yīng)當在有臨床試驗質(zhì)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(zhì)量管理文件與《醫(yī)療器械臨床試驗質(zhì)量管理規(guī)范》（GCP）有差異，應(yīng)詳細說明差異內(nèi)容，并充分證明差異內(nèi)容不影響研究結(jié)果的真實性、科學性、可靠性及可追溯性，且能夠保障受試者權(quán)益。申請人及臨床試驗機構(gòu)應(yīng)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(yīng)真實、科學、可靠、可追溯，申請人應(yīng)提供完整的試驗數(shù)據(jù)，不得篩選。而且申請人應(yīng)確保在境外開展的臨床試驗?zāi)康倪m當，試驗設(shè)計科學合理，試驗結(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險得以保護。

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自薦信   http://www.gfgfgf.com.tw/mzyy/   2018年09月08日 簡歷製作
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