中成药“生死大考”倒计时:行业洗牌加速 头部企业率先突围
Zheng Quan Ri Bao Wang·2026-02-03 11:15

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changes may cause short-term challenges, they are expected to lead to healthier industry development by eliminating outdated practices and improving product quality [4]

中成药“生死大考”倒计时:行业洗牌加速 头部企业率先突围 - Reportify