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日韩再生医学“双轨制”监管模式介绍及对我国的启示
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| 篇名： | 日韩再生医学“双轨制”监管模式介绍及对我国的启示 |
| TITLE： | “Dual-track regulatory”models for regenerative medicine in Japan and the Republic of Korea and their impli-cations for China |
| 摘要： | 目的 为完善我国细胞与基因治疗产品、疗法的监管提供参考和建议。方法系统梳理日本和韩国对再生医学产品、疗法的“双轨制”监管框架，总结二者的有益经验并探索形成对我国监管工作的优化建议。结果与结论日本和韩国针对“再生医学产品的注册临床试验”和“再生医学疗法的临床研究”两个路径均建立了清晰的管理流程，并遵循“风险分级”和“全过程管理”的共性思路。据此，建议我国完善顶层立法，明确细胞与基因治疗产品、疗法的监管范畴；厘清各部门的监管职责，提升监管的科学性；合理把握监管尺度，坚持规范和激励并重，加速再生医学产品的临床转化。 |
| ABSTRACT： | OBJECTIVE To provide references and recommendations for improving the regulatory framework for cell and gene therapy products and treatments in China. METHODS This study systematically examined the “dual-track regulatory” frameworks for regenerative medicine products and treatments in Japan and the Republic of Korea， summarized their beneficial experiences， and explored optimization strategies for China’s regulatory practices. RESULTS & CONCLUSIONS Both Japan and the Republic of Korea have established clear management processes for two distinct pathways “registered clinical trials for regenerative medicine products” and “clinical research on regenerative medicine treatments” guided by shared principles of “risk stratification” and “full lifecycle oversight”. Based on these findings， it is recommended that China： strengthen top-tier legislative framework to explicitly delineate the regulatory scope governing cell and gene therapy products and treatments； clarify the jurisdictional responsibilities of relevant regulatory bodies to enhance oversight efficacy； appropriately calibrate the regulatory scope， and adopt a balanced regulatory approach that harmonizes standardization with innovation incentives， thereby accelerating the clinical translation of regenerative medicine products. |
| 期刊： | 2025年第36卷第15期 |
| 作者： | 杨伊凡；谢金平；邵蓉 |
| AUTHORS： | YANG Yifan，XIE Jinping，SHAO Rong |
| 关键字： | 再生医学；细胞与基因治疗；双轨制；监管科学；日本；韩国 |
| KEYWORDS： | regenerative medicine； cell and gene therapy； dual-track regulatory； regulatory science； Japan； the Republic of |
| 阅读数： | 4 次 |
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