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                可吸收止血类产品应提交何种资料证明产品的止血作用机理?

                  申请人应提交能够有效证明或阐述该申报产品的止血作用原理的技术或证明性资料。申请人应详细阐↓明申报产品的止血机理,描述产品如何影响止血过程,产品在止血过程中的优势作用,确认该止血机理结合所申报产品应用是否科学合理。对支持该止血原理的国内外研究文献进行综述,并提交具体支持该止血原理的相关科学文献原文及中文翻译件。阐明是否已有应用相同止血原理的产品在境内外上市,并研究所申报产品是否会可能引起血栓形成、凝血障碍等与其使用相关的不良反应。

                  2017-11-02 14:23