创新链/学科链/研发链/产业链

新药研发前沿动态 / 医药领域趋势进展

欧洲联合临床评估实践及对我国的启示

Joint Clinical Assessment in Europe and Their Implications for China

  • 摘要: 欧洲联合临床评估(Joint Clinical Assessment,JCA)制度是欧盟卫生技术评估领域的重要改革措施,其成功实施对全球医疗技术准入模式具有深远影响。针对欧盟JCA制度的政策演进与关键实践,通过文献综述与政策分析,系统梳理欧盟法规及JCA核心内容,并结合试点案例评估其运行、影响与挑战。研究发现,JCA可以避免重复审查、降低人力成本、统一评估标准和流程。然而,在实施过程中,仍面临成员国之间的协调难度、数据隐私及技术能力差异等挑战。中国可借鉴其经验,加强跨部门协作与数据标准化,构建更加高效公平的评估机制。

     

    Abstract: The Joint Clinical Assessments (JCA) system in Europe is a significant reform in the EU's Health Technology Assessment (HTA) field, and its successful implementation has profound implications for global medical technology access models. This article focuses on the policy evolution and key practices of the EU JCA system. Through a literature review and policy analysis, it systematically outlines the EU regulatory framework and core JCA content, and evaluates its operation, impact, and challenges using pilot cases. The findings indicate that the implementation of JCA can reduce duplicative assessments, lower human resource costs, and harmonize clinical standards. However, challenges such as coordination among member states, data privacy concerns, and disparities in technical capacities remain significant obstacles to further optimization. China can draw on the JCA experience to enhance interdepartmental collaboration and data standardization, creating a more efficient and equitable evaluation system.

     

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