醫(yī)療器械注冊使用境外臨床試驗數據的基本原則

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據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據技術指導原則。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(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

　　境外臨床試驗數據應真實、科學、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。

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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 簡歷製作
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