醫療器械注冊使用境外臨床試驗數據的基本原則

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　　為了避免或減少申請人通過(guò)醫療器械境外臨床試驗數據申報注冊過(guò)程中重復性臨床試驗，加快醫療器械在我國上市進(jìn)程，國家食品藥品監督管理總局組織制定了接受醫療器械境外臨床試驗數據技術(shù)指導原則。其中涉及的境外臨床試驗數據是指，全部或同期在境外具備臨床試驗開(kāi)展所在國家（地區）要求條件的臨床試驗機構中，對擬在我國申報注冊的醫療器械在正常使用條件下的安全有效性進(jìn)行確認的過(guò)程中所產(chǎn)生的研究數據，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《世界醫學(xué)大會(huì )赫爾辛基宣言》確定的倫理準則。申請人同時(shí)需說(shuō)明采用的臨床試驗開(kāi)展所在國家（地區）的倫理、法律、法規所制定的規范和標準，或國際規范和標準。

　　二、依法原則

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

　　三、科學(xué)原則

　　境外臨床試驗數據應真實(shí)、科學(xué)、可靠、可追溯，申請人應提供完整的試驗數據，不得篩選。而且申請人應確保在境外開(kāi)展的臨床試驗目的適當，試驗設計科學(xué)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(fēng)險得以保護。

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smlqf3 發(fā)表于 2018-9-8 00:52
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