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中成药说明书“尚不明确”?那就再见吧
Qi Lu Wan Bao· 2026-02-01 16:27
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]
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].
张贵民在北京大学开讲:中医药价值重构与企业新价值论
Qi Lu Wan Bao Wang· 2025-05-15 08:47
Group 1 - The core value of a company lies in providing high-quality products and services to society, emphasizing "value creation" as the central theme of the new value theory [1] - Zhang Guimin highlights the holistic view of traditional Chinese medicine (TCM) and its core principle of achieving balance in the human body, with a significant advantage in "preventive treatment" [1][2] - The digitalization rate of traditional Chinese medicine extraction at Runan Pharmaceutical reaches 95%, achieving full-process automation, indicating the integration of TCM with modern technology [2] Group 2 - The new value theory recognizes the importance of innovative thinking and the transformation of created value into shares and wealth, as emphasized by industry experts [2] - The book "New Value Theory" is described as a vital local management work that provides deep insights into "value creation," "value evaluation and distribution," and "value reconstruction" [3] - The inclusion of Zhang Guimin's "New Value Theory" in the collection of Peking University Library signifies its recognition and contribution to the field of enterprise management theory [3]