更好保障公众安全用中药

Core Viewpoint - A significant number of traditional Chinese medicine (TCM) products are expected to exit the market due to new regulations from the National Medical Products Administration, which will require clearer safety information in product instructions by July 1, 2026 [1] Group 1: Regulatory Impact - The new regulation aims to improve the clarity of contraindications, adverse reactions, and precautions in TCM product instructions, addressing the current issue of many entries marked as "unclear" [1] - Experts believe that this regulation will not lead to a mass withdrawal of TCM products but will facilitate the orderly exit of "zombie approvals" that have low clinical value and have not been produced for a long time [1] Group 2: Industry Transformation - The regulation is expected to enhance patient safety through clearer risk warnings, improve quality control of TCM, and promote a shift from quantity expansion to quality prioritization in the industry [1] - This shift will encourage resources to concentrate on companies with high clinical value, strong research foundations, and superior quality systems, fostering a high-quality transformation of the TCM industry [1] Group 3: Recommendations for Pharmaceutical Companies - Pharmaceutical companies are advised to prioritize the review of main products, conduct real-world studies, literature reviews, and necessary toxicology tests, and revise product instructions accordingly [2] - Companies should also establish robust pharmacovigilance systems to ensure drug safety and compliance with regulations, while evaluating and canceling low-value approvals to focus on high-quality products that meet clinical needs [2] Group 4: Understanding TCM - There is a need to recognize the fundamental differences in treatment logic between TCM and Western medicine, with TCM's efficacy heavily relying on syndrome differentiation [2] - Classic formulations with proven efficacy and a long history of use generally have lower risks and are easier to revise, while products with unclear sources and arbitrary formulations require more attention [2] Group 5: Broader Responsibilities - To ensure effective use of TCM, both companies and the medical sector must enhance their capabilities in syndrome differentiation and avoid empirical prescribing that deviates from syndrome-based treatment [3] - Public education is essential to improve understanding of TCM and promote safe medication practices, contributing to the orderly development of the TCM industry [3]