Long Xiaohong, Zhang Jie, Yang Li
School of Business Administration, Shenyang Pharmaceutical University, Shenyang, China.
Front Med (Lausanne). 2025 Jun 16;12:1559703. doi: 10.3389/fmed.2025.1559703. eCollection 2025.
The reform of the development and approval system for traditional Chinese medicines (TCMs) has been in progress for several years. This reform has restructured the registration classifications and established a distinctive evaluation and registration evidence system for TCMs. This study compiled comprehensive data on all new TCMs approved in China from January 2013 to November 2024, analyzing drug characteristics and the changes in development and review timelines before and after the reform. The focus was particularly on the evaluation and registration evidence requirements, clinical development pathways, and the application of pivotal clinical and real-world evidence in supporting TCM approvals. Between 2013 and 2024, 77 new TCMs were approved for marketing. Post-reform, there has been a gradual increase in the number of new TCMs, with a notably significant rise in ancient classic formulas. Following 2020, the establishment of the "three-in-one" evaluation and registration evidence system was implemented to accommodate the distinct characteristics of TCMs. This system revealed significant discrepancies in the registration classifications for new TCMs, particularly concerning TCM theory, human use experience, and clinical trials. These discrepancies have led to varied clinical development pathways. Importantly, the findings suggest that the marketing approval of new TCMs is no longer solely reliant on Randomized Controlled Trials. Instead, TCM theories and empirical human use experience constitute critical evidence for TCM approval. Additionally, evidence derived from real-world studies has become instrumental in supporting the marketing of TCMs. Although the review time for TCMs has significantly decreased after the reform, the overall development time has increased. Simultaneously, this article proposed specific recommendations to address the array of challenges encountered by new TCMs in the realms of development and approval.
中药研发与审批制度改革已推进数年。此次改革重构了注册分类，建立了独特的中药评价与注册证据体系。本研究收集了2013年1月至2024年11月在中国获批的所有新型中药的综合数据，分析了药物特性以及改革前后研发和审评时间线的变化。重点尤其关注评价与注册证据要求、临床研发路径，以及关键临床试验和真实世界证据在支持中药获批方面的应用。2013年至2024年期间，有77种新型中药获批上市。改革后，新型中药数量逐渐增加，其中古代经典名方的增长尤为显著。2020年之后，实施了“三合一”评价与注册证据体系，以适应中药的独特特性。该体系显示新型中药在注册分类方面存在显著差异，特别是在中医理论、人用经验和临床试验方面。这些差异导致了不同的临床研发路径。重要的是，研究结果表明新型中药的上市批准不再仅仅依赖随机对照试验。相反，中医理论和人用经验构成了中药获批的关键证据。此外，来自真实世界研究的证据在支持中药上市方面发挥了重要作用。虽然改革后中药的审评时间大幅缩短，但整体研发时间有所增加。同时，本文针对新型中药在研发和审批领域遇到的一系列挑战提出了具体建议。
