大批中成药将被淘汰

Core Viewpoint - The article discusses the impending implementation of the State Drug Administration's regulations on traditional Chinese medicine (TCM) registration, which will significantly impact the market by eliminating over 70% of existing TCM products that lack clear safety information in their labeling [1][3]. Summary by Sections - The new regulation, referred to as the "life and death clause" for TCM, will take effect on July 1, 2026, and mandates that any TCM product with unclear safety information in its instructions will not be eligible for re-registration after three years from the regulation's enforcement [1][3]. - Currently, approximately 57,000 TCM products have valid approval numbers, with over 70% facing potential elimination due to safety information issues [1][3]. - A study indicated that in the 2018 version of the National Essential Medicines List, only 20.64% of TCM products had adverse reaction labels, 30.1% had contraindications, and a mere 1.07% addressed drug interactions, highlighting the reliance on vague statements for market circulation [1][3]. - The regulatory changes are aimed at ending the era of ambiguous disclaimers in TCM product labeling, compelling manufacturers to provide comprehensive post-marketing safety data [1][3]. - In addition to labeling requirements, the regulatory scope will extend to the entire TCM industry chain, with new regulations on the production supervision of TCM set to be enforced on March 1, 2026, raising industry entry barriers [4].