中成药说明书“尚不明确”?那就再见吧

Policy Regulations - The new regulation, effective from July 1, 2023, mandates that any traditional Chinese medicine (TCM) with "unclear" labels in contraindications, adverse reactions, or precautions will not be re-registered after three years [3][4] - The regulation aims to enhance the management of TCM throughout its lifecycle, requiring holders to monitor and evaluate safety risks and update labels accordingly [3][4] Market Situation - Despite the impending deadline, some commonly used TCMs still carry "unclear" labels, indicating a need for compliance [5][6] - A survey of pharmacies revealed that several TCM products, including those from well-known brands, still have safety information marked as "unclear" [6][7] Industry Response - Pharmaceutical companies are actively working to revise their product labels in compliance with the new regulations, with many already completing updates for core products [9] - Companies like Rongchang Pharmaceutical and Yiling Pharmaceutical have reported that they are updating their product information to eliminate "unclear" labels and enhance consumer understanding [9] Industry Outlook - The new regulation is seen as a necessary shift from quantity expansion to quality prioritization in the TCM industry, promoting safer medication practices [10] - The implementation of this policy is expected to phase out low-quality products lacking safety data, thereby concentrating resources on higher-quality enterprises and products [10]