Industry Overview - The "Special Regulations on the Registration Management of Traditional Chinese Medicine" is set to reshape the Chinese medicine industry, with a deadline of July 1, 2026, for compliance [1] - The regulation mandates that any traditional Chinese medicine (TCM) with unclear safety information in its instructions will not be re-registered after three years from its implementation on July 1, 2023 [1] Safety and Quality Concerns - Concerns have been raised about the safety of TCM; however, data shows that TCM accounts for only 12% of adverse drug reactions, compared to 81% for chemical drugs, indicating relative safety [2] - The core purpose of the new regulation is to enhance the safety information in TCM product instructions, promoting high-quality development in the industry [2] Company Responses - Leading companies like Yiling Pharmaceutical and Rongchang Pharmaceutical have proactively updated their product instructions to comply with the new regulations, ensuring clear statements on contraindications, adverse reactions, and precautions [3] - Yiling Pharmaceutical has 17 patented TCM products that have been revised according to regulatory requirements, while Rongchang Pharmaceutical has simplified instructions for better consumer understanding [3] Industry Transformation - The industry is at a crossroads, facing short-term compliance pressures while needing to balance innovation and regulation in the long term [4] - The government encourages high-quality development and innovation in TCM, suggesting that products with clear evidence of safety and efficacy will gain a competitive edge in the market [4] - Although the policy changes may cause short-term challenges, they are expected to lead to healthier industry development by eliminating outdated practices and improving product quality [4]

随着2026年的日历翻过一页，医药行业正屏息以待那个即将到来的关键节点。距离2026年7月1日—— 《中药注册管理专门规定》第七十五条的最终落地期限，已不足半年。 这一被业内称为中成药"生死条款"的规定，早在2023年7月1日就已正式实施。规定明确指出：自实施之 日起满3年后（即2026年7月1日），药品说明书中的【禁忌】【不良反应】【注意事项】中任何一项仍 标注"尚不明确"的，将依法不予再注册。 这意味着，数万个曾以"尚不明确"作为护身符的中成药批文，如果不能在未来几个月内拿出确凿的临床 数据并完成修订，将彻底退出历史舞台。据中国中药协会此前监测数据显示，截至2025年底，我国中成 药有效批准文号约5.7万个，其中曾有超过4万个批文在上述安全项目中存在信息缺失。如今，留给这些 药品的窗口期已稍纵即逝。 补齐短板，非"洪水猛兽" 对于由于历史原因长期在说明书中均标注"尚不明确"的中成药而言，这不仅是一次合规大考，更是一场 关乎生死的"淘汰赛"。在这场倒计时中，记者深入探访发现，不同于部分中小药企的仓促应对，以岭药 业、荣昌制药等行业头部企业早已完成布局，率先告别了"模糊安全时代"。 "生死条款"倒计时：告别" ...