中药注射剂正迎来一场关乎行业命运的系统性重塑。 《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》日前发布，其中用两段文字解决"药品注 射剂"问题，第十一条、第二十五条均指向了注射剂的管理：未来口服制剂能够满足临床需求的，不批 准注射制剂上市；肌肉注射制剂能够满足临床需求的，不批准静脉注射制剂上市；此外，还将力争用 5~10年，对已上市的药品注射剂进行再评价。 中药注射剂正迎来一场关乎行业命运的系统性重塑。从2009年首轮安全性再评价启动，到2021年《中药 注射剂上市后再评价技术指导原则（试行）》构建起"法律—法规—指南"三层政策体系，再到当前常态 化监管下的分类施策，这场历时十余年的监管升级，本质上是对中药注射剂"安全、有效、质量可控"核 心属性的回归校准，也为行业从"野蛮生长"迈向高质量发展立下了刚性标尺。 面对这场"生死大考"，药企需从战略、执行、合规三个维度构建应对体系。战略层面，应摒弃侥幸心 理，成立高层牵头的专项工作组，对产品进行分类评估，集中资源保障核心品种通过再评价，果断剥离 边缘产品；中小企业可通过与CRO机构、科研院所、大型药企合作，实现资源共享、成本分摊，无力 承担再评价成本的企业 ...

Core Viewpoint - The National Medical Products Administration (NMPA) of China is accelerating the post-marketing research and evaluation of traditional Chinese medicine (TCM) injections, signaling a push for improved safety and efficacy standards in the industry [1][5][9]. Regulatory Developments - The NMPA, along with the National Health Commission and the State Administration of Traditional Chinese Medicine, has drafted a proposal to enhance post-marketing research for TCM injections, which is currently open for public consultation [1][5]. - A "淘汰令" (elimination order) has been introduced, stating that TCM injections that do not comply with research and evaluation requirements may face deregistration or cancellation of their drug registration certificates [5][7]. Industry Context - TCM injections have been controversial in China, with a history of safety concerns, including reported deaths following their use. The NMPA has highlighted the need for ongoing monitoring and evaluation of these products [3][5]. - The market for TCM injections has grown significantly, with annual sales exceeding 100 billion RMB, indicating a substantial commercial scale despite regulatory scrutiny [3][9]. Product Focus - The proposal prioritizes TCM injections listed in the National Essential Medicines List and the National Medical Insurance Catalog, such as Qingkailing Injection and Heduoning Injection, for post-marketing research [6][7]. - The National Essential Medicines List includes 10 TCM injections, while the National Medical Insurance Catalog includes 58, indicating a broad scope for evaluation [7]. Market Impact - The acceleration of post-marketing research may lead to the exit of less viable products from the market, promoting a competitive environment that favors high-quality offerings [8][9]. - Major TCM injections have historically generated significant revenue, with products like Qingkailing Injection projected to exceed 1 billion RMB in sales in 2024 [9][11]. Historical Context - Previous regulatory actions have included the proposal to eliminate certain TCM injection products, reflecting ongoing efforts to ensure safety and efficacy in the market [12][13].