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

LI Weimiao, HAN Sheng, SHI Luwen, CHEN Jing. Joint Clinical Assessment in Europe and Their Implications for China[J]. Progress in Pharmaceutical Sciences, 2025, 49(5): 330-336. DOI: 10.20053/j.issn1001-5094.20250043
Citation: LI Weimiao, HAN Sheng, SHI Luwen, CHEN Jing. Joint Clinical Assessment in Europe and Their Implications for China[J]. Progress in Pharmaceutical Sciences, 2025, 49(5): 330-336. DOI: 10.20053/j.issn1001-5094.20250043

Joint Clinical Assessment in Europe and Their Implications for China

  • 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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