记者丨 唐唯珂 编辑丨季媛媛 中成药淘汰赛序幕拉开！大批中成药将退出市场。 距离2026年7月1日仅剩半年时间，国家药监局《中药注册管理专门规定》第七十五条的 落地进入最后窗口期。 这一被业内称为中成药"生死条款"的规定明确，自2023年7月1日施行满三年起，说明书 【禁忌】【不良反应】【注意事项】任意一项仍标注"尚不明确"的中成药，再注册申请 将依法不予通过。这意味着，国内现存约5 . 7万个中成药有效批准文号中，超7 0%存在安 全信息标注问题的批文将面临淘汰，一场由监管驱动的中药产业深度出清正式进入攻坚 阶段。 此次监管新政的核心，是彻底终结中成药说明书长期以来的"尚不明确"时代，倒逼药品 持有人补齐上市后安全数据短板。 中国食品药品监管杂志此前研究显示，2018年版《国家基本药物目录》中2 6 8个中成药品 种的465份说明书里，不良反应、禁忌、药物相互作用的标注率仅为2 0 . 6 4%、3 0 . 1%和 1 . 0 7% ， 大 量 品 种 依 靠 模 糊 表 述 完 成 上 市 后 的 市 场 流 通 。 而 随 着 再 注 册 大 考 临 近 ， 这 种"模糊免责"的模式已彻底失去生存空间。 ...

21世纪经济报道记者唐唯珂 距离2026年7月1日仅剩半年时间，国家药监局《中药注册管理专门规定》第七十五条的落地进入最后窗 口期。 这一被业内称为中成药"生死条款"的规定明确，自2023年7月1日施行满三年起，说明书【禁忌】【不良 反应】【注意事项】任意一项仍标注"尚不明确"的中成药，再注册申请将依法不予通过。这意味着，国 内现存约5.7万个中成药有效批准文号中，超70%存在安全信息标注问题的批文将面临淘汰，一场由监 管驱动的中药产业深度出清正式进入攻坚阶段。 此次监管新政的核心，是彻底终结中成药说明书长期以来的"尚不明确"时代，倒逼药品持有人补齐上市 后安全数据短板。 中国食品药品监管杂志此前研究显示，2018年版《国家基本药物目录》中268个中成药品种的465份说明 书里，不良反应、禁忌、药物相互作用的标注率仅为20.64%、30.1%和1.07%，大量品种依靠模糊表述 完成上市后的市场流通。而随着再注册大考临近，这种"模糊免责"的模式已彻底失去生存空间。 国家药监局的监管动作已提前落地，2025年全年发布多批中成药说明书修订公告，活力苏口服液、固肾 生发丸、小活络制剂等多款常用品种均被要求补充三大核心 ...

Core Viewpoint - The article emphasizes the integration of traditional Chinese medicine (TCM) with modern technology and innovation, showcasing Tong Ren Tang's efforts in smart manufacturing, talent development, and sustained research and development (R&D) investments to enhance productivity and maintain its industry leadership [12]. Group 1: Smart Manufacturing - Tong Ren Tang has established multiple smart manufacturing production lines, including the first domestic online detection production line for large honey pills, demonstrating a commitment to technological advancement in TCM production [5][6]. - The Daxing factory has transitioned from digital smart production lines to data-driven smart workshops, utilizing real-time monitoring systems to enhance production efficiency and quality [5][6]. - The integration of AI algorithms allows for real-time monitoring of production parameters, improving overall product quality and standardization [5]. Group 2: Talent Development - The company recognizes the importance of talent in driving innovation and has implemented a dual-channel approach for talent acquisition and development, focusing on reducing internal inefficiencies [7]. - Tong Ren Tang has established a comprehensive training system for professional skills, covering various aspects of TCM production, and has actively participated in national skill competitions, achieving notable success [8]. - The company has also introduced a contractual management system for managerial positions to enhance organizational efficiency and foster a culture of innovation [7]. Group 3: Research and Development - During the 14th Five-Year Plan period, Tong Ren Tang has invested over 1.6 billion yuan in R&D, reinforcing its commitment to scientific innovation and the integration of industry, academia, and research [9]. - The company has established long-term collaborations with academic institutions and research teams to focus on new product development and post-market evaluation [10]. - Recent achievements include the registration of several products in Canada, indicating the company's expanding international presence and commitment to quality [11].

Group 1 - The core idea of the articles revolves around the health implications and recommendations associated with the "White Dew" solar term, emphasizing the need for dietary and lifestyle adjustments to adapt to the changing weather conditions [1][2] - The article highlights the significance of "White Dew" as a transitional period into autumn and winter, where the focus should be on preventing dryness, nourishing the lungs, and maintaining warmth [2] - Recommendations for diet include increasing the intake of moistening foods such as pears, honey, and various herbs, while avoiding spicy and cold foods to prevent lung and spleen issues [1][2] Group 2 - Common health issues during the "White Dew" period include respiratory and digestive problems, with symptoms like dry throat, nasal bleeding, and dry skin being prevalent [2] - The article suggests remedies such as consuming lily and pear soup or herbal teas to alleviate symptoms, and emphasizes the importance of maintaining a balanced diet for those with weak digestive systems [2] - Emotional well-being is also addressed, with suggestions for outdoor activities and social interactions to combat the "autumn blues," promoting a positive mindset during this transitional season [2]