王政. 我国仿制药上市审批等待期问题研究[J]. 内江师范学院学报, 2025, 40(11): 120-126. DOI: 10.13603/j.cnki.51-1621/z.2025.11.018
    引用本文: 王政. 我国仿制药上市审批等待期问题研究[J]. 内江师范学院学报, 2025, 40(11): 120-126. DOI: 10.13603/j.cnki.51-1621/z.2025.11.018
    WANG Zheng. On the Waiting Period in the Listing Approval Process for Generic Drugs in China[J]. Journal of Neijiang Normal University, 2025, 40(11): 120-126. DOI: 10.13603/j.cnki.51-1621/z.2025.11.018
    Citation: WANG Zheng. On the Waiting Period in the Listing Approval Process for Generic Drugs in China[J]. Journal of Neijiang Normal University, 2025, 40(11): 120-126. DOI: 10.13603/j.cnki.51-1621/z.2025.11.018

    我国仿制药上市审批等待期问题研究

    On the Waiting Period in the Listing Approval Process for Generic Drugs in China

    • 摘要: 我国新《专利法》确立了药品专利纠纷早期解决机制。仿制药上市审批等待期作为早期解决机制中的配套制度对平衡原研药企、仿制药企与社会公众三方利益具有重要作用。目前等待期制度的程序框架缺乏系统性,因此有必要对等待期制度在实际运行中的程序进行梳理。在实践中等待期制度还存在一些不足,如等待期时长设置不合理、缺乏原研药企滥用等待期的法律规制、相关部门职能协调不足等。在完善药品专利纠纷早期解决机制实施过程中,建议设置弹性等待期时长、完善原研药企滥用等待期的法律规制、强化各部门之间的职能协调性。

       

      Abstract: The newly revised Patent Law of the People’s Republic of China has established an early resolution mechanism for pharmaceutical patent disputes. The waiting period for the marketing approval of generic drugs serves as a supporting system within this early resolution mechanism. The waiting period plays a crucial role in balancing the interests of original drug manufacturers, generic drug manufacturers, and the general public. The current procedural framework of the system for the waiting period lacks systematic design. It is thus necessary to clarify and streamline the procedures governing its actual operation. In practice, the waiting period system still exhibits several deficiencies. These include unreasonable duration settings, a lack of legal safeguards against abuse by original drug manufacturers, and insufficient coordination among relevant departments. The improvement of early resolution mechanism for the pharmaceutical patent should include the establishment of a flexible waiting period. This must be supported by stronger legal regulations against abuse of this period by originator companies and improved functional coordination across departments.

       

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