中成药说明书规范修订
Search documents
中成药“尚不明确”退场倒计时!记者实探:部分常用药仍有标注
Qi Lu Wan Bao· 2026-01-29 11:59
Core Viewpoint - The implementation of the new regulations on traditional Chinese medicine (TCM) product labeling aims to eliminate the "unclear" status in safety information, enhancing the quality and safety of TCM products in the market [1][2][13]. Regulatory Changes - The new regulations, effective from July 1, 2023, require TCM product holders to manage the entire lifecycle of their products and improve the safety information in their labeling, specifically regarding contraindications, adverse reactions, and precautions [1][2]. - By July 1, 2026, any TCM product with "unclear" safety information will not be eligible for re-registration, emphasizing the urgency for companies to update their product labels [1][2]. Industry Response - Many pharmaceutical companies have begun revising their product labels to comply with the new regulations. For instance, companies like Rongchang Pharmaceutical and Yiling Pharmaceutical have completed revisions for their core products, ensuring clear safety information [11][12]. - The industry is adapting by adjusting procurement strategies to focus on compliant products and gradually reducing the inventory of those with high re-registration risks [14]. Market Observations - Despite the new regulations, some commonly used TCM products still display "unclear" safety information, indicating a gap in compliance that needs to be addressed [7][8]. - Reports indicate that TCM accounts for 12% of adverse drug reaction reports, highlighting the need for clearer safety information to mitigate risks associated with TCM usage [7][13]. Future Outlook - The new regulations are expected to promote a shift in the TCM industry from quantity expansion to quality prioritization, ultimately benefiting public health by providing clearer safety guidelines [13][14]. - The elimination of "unclear" labels is anticipated to enhance consumer confidence in TCM products, reducing the risk of unreasonable medication use [14].