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].

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].

Core Viewpoint - The safety concerns surrounding traditional Chinese medicine (TCM) injection solutions, particularly the case of a patient who died after receiving a Schisandra injection, have reignited discussions about the risks associated with these products and the need for improved regulatory oversight [1][3][11]. Industry Overview - The market for TCM injection solutions has seen a significant decline, with total market size dropping from 831.3 billion in 2015 to 479.8 billion in 2023, a nearly 50% reduction [7]. - Major companies in the sector, such as ST Longjin and Dali Pharmaceutical, have faced severe financial difficulties, with ST Longjin's revenue declining by 36.19% to 0.48 billion in 2024 [8][9]. - Despite the challenges, some companies remain optimistic about the potential for TCM injections, with predictions that products like Kanyuan Pharmaceutical's Hot Toxic Ning injection could benefit from increased insurance coverage and expanded indications [5]. Regulatory Environment - The National Medical Products Administration (NMPA) has been actively revising the instructions for TCM injections, adding warnings about severe allergic reactions and requiring monitoring after administration [11][12]. - Recent changes in the 2023 medical insurance drug directory have relaxed some payment restrictions on TCM injections, allowing for broader use in clinical settings [13][14]. - However, the existing risk management system still has shortcomings, such as delayed implementation of revised instructions and insufficient training for medical staff on proper medication use [12]. Safety Concerns - Reports indicate that adverse reactions to TCM injections, particularly allergic reactions, are common, especially among older patients [3][6]. - The complexity of TCM injection formulations and the potential for contamination during production contribute to safety risks [6][10]. - The industry faces ongoing scrutiny regarding the quality control of TCM injections, with calls for stricter regulations and better monitoring of adverse reactions [10][15]. Future Outlook - The TCM injection industry must navigate its way out of the current downturn by focusing on product upgrades, regulatory compliance, and enhancing safety monitoring systems [10][16]. - Companies are encouraged to adopt modern scientific methods to assess the safety of TCM injections and to implement stricter quality control measures [16].