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谢伏瞻
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李培林
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    我国药品上市许可人制度研究

    摘要

    基于我国上市许可人与生产许可人合并管理模式和发达国家药品上市许可制度的对比和分析,本文认为实施上市许可制度将会带来各主体权责明晰、监管效率和力度的提高,促进技术转让市场化发展以及促进专业分工和资源合理配置等优势。我国在引入上市许可制度要设立准入资格、建立生产和上市许可分离申请程序、探索强制性保险机制、明确境外申请人责任、促进上市许可人成为技术转让和委托生产市场的主导,建立相应配套规制性法规。

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    Abstract

    Based on the comparative analysis between the Marketing Authorization Holder (MAH) system of developed countries and Chinese binding management mode of MAH and Production License Holder,the author discussed the advantage of MAH system to be established. If MAH system was established in China,it would promote the enhancing of administration,defining of company legal behavior,marketing developing of the technology transferring,specializing deeply of division of labor and the good resource allocation. Based on the above mentioned,the author suggested that Chinese drug administration should establish the related regulations,such as admittance MAH system,applying program of separating between production and marketing,enforcing insurance system,making MAH being the leading of the production and marketing,building the regulations of MAH system,and so on.

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    作者简介
    邵蓉:
    陈永法:
    信明慧:
    王文沛:
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