多起死亡事件后，一批中药注射液或被淘汰

Core Viewpoint - The recent regulatory measures for traditional Chinese medicine (TCM) injection solutions aim to enhance safety and efficacy research, addressing public concerns over adverse reactions and ensuring better patient outcomes [2][4][19]. Regulatory Changes - The National Medical Products Administration, National Health Commission, and National Administration of Traditional Chinese Medicine issued a draft requiring post-marketing studies for TCM injection solutions that were approved before the 2019 revision of the Drug Administration Law [2][19]. - This marks the strictest regulatory approach to TCM injection solutions, which have historically been linked to serious adverse reactions [2][4]. Industry Background - TCM injection solutions emerged during the wartime period, with over 130 varieties currently available, some generating annual sales exceeding 1 billion [2][3]. - Despite their prevalence, TCM injection solutions have faced scrutiny regarding their safety and efficacy, with 12% of adverse reactions attributed to TCM, a quarter of which are linked to injection solutions [3][4]. Adverse Reactions - Serious adverse reactions, including anaphylactic shock and acute liver failure, have been reported, raising public concern and prompting calls for stricter regulations [3][4][19]. - Notable cases include a patient who died after receiving a TCM injection, highlighting the potential risks associated with these products [3][4]. Market Dynamics - The market for TCM injection solutions has seen a decline, with a drop from over 100 billion in 2016 to half of that figure in recent years due to regulatory and reimbursement pressures [11][19]. - Companies are now facing challenges in adapting to the new regulatory landscape, with many unsure about how to conduct post-marketing studies effectively [11][19]. Research and Evaluation - The post-marketing research will involve both non-clinical and clinical studies, focusing on safety and efficacy evaluations [11][12]. - The complexity of TCM formulations poses challenges for clinical trials, as traditional metrics for efficacy may not apply [13][14]. Future Implications - The new regulations are expected to lead to a significant reshaping of the TCM injection market, potentially eliminating low-quality products and companies that cannot meet the new standards [19]. - The establishment of a dedicated expert group for TCM injection evaluation signifies a commitment to improving the quality and safety of these products [18][19].