Core Viewpoint - The recent announcement by the National Medical Products Administration, National Health Commission, and National Administration of Traditional Chinese Medicine regarding the post-marketing research and evaluation of traditional Chinese medicine (TCM) injections marks the strictest regulatory measures in history, aiming to enhance the safety and efficacy of these products for patients [1][2][3]. Group 1: Regulatory Changes - The new policy mandates that all TCM injections approved before the 2019 revision of the Drug Administration Law must undergo post-marketing research, which includes proactive evaluations, mandatory assessments, and legal eliminations of certain products [1][2]. - The policy's implementation is a response to the frequent severe adverse reactions associated with TCM injections, which have raised public concerns about their safety [3][12]. Group 2: Market Impact - The market for TCM injections was over 100 billion in public medical institutions in 2016, but has since halved due to regulatory and reimbursement policies [7][11]. - The new regulations may lead to a significant reshaping of the TCM injection industry, potentially eliminating low-quality products and companies that cannot meet the new standards [13]. Group 3: Safety Concerns - Adverse reactions from TCM injections account for 12% of all reported adverse reactions, with a quarter of these stemming from injections, highlighting the serious risks involved [2]. - The complexity of TCM injection components and their direct intravenous administration increase the likelihood of severe allergic reactions compared to oral TCM [2][6]. Group 4: Research and Evaluation Challenges - Companies face challenges in conducting post-marketing research due to high costs and unclear guidelines for evaluating efficacy, which complicates the process of proving the effectiveness of TCM injections [7][8][11]. - The evaluation process will require a clear understanding of adverse reactions and their causes, as well as the establishment of quality management throughout the production process [12][13]. Group 5: Historical Context - The call for re-evaluation of TCM injections has been ongoing for nearly two decades, with previous attempts failing due to various industry challenges [11][12]. - The establishment of an expert working group in December 2023 signifies a renewed commitment to addressing the safety and efficacy of TCM injections [12].

作者： 张铃 封图：图虫创意 传统中药多为口服，消化系统代谢能显著降低毒性，而中药注 射液成分复杂，直接注入静脉，易引发过敏性休克等严重速发 型过敏反应。近几年，张铭就耳闻目睹了多起与中药注射液相 关的严重不良反应/事件，其中包括一些引发过较大舆情的案 例。 "让中药注射液做更充分的安全性和有效性研究，对患者是件大好事。"10月16日，看到有关部门近日发布 的一份征求意见稿后，华中地区某三甲医院主任医师张铭忍不住叫好。 10月9日，国家药监局、国家卫健委与国家中医药局联合发布了《关于进一步推进药品上市许可持有人加 快开展中药注射剂上市后研究和评价工作的公告（征求意见稿）》。这份意见稿要求在《中华人民共和国 药品管理法》（2019年修订）实施前上市的中药注射液都需要进行上市后研究——主动评价一批、责令评 价一批、依法淘汰一批。这是史上最严的中药注射液监管措施。 中药注射液是特殊历史时期的产物，第一支中药注射液诞生于1941年，属于抗战时期的应急药品。此后几 十年，中药注射液行业野蛮生长，目前，有超过130种中药注射液品种，其中包括多款年销售额超10亿元 的重磅品种。这些注射液覆盖心脑血管病、肿瘤、感染疾病等多种 ...