超75%中成药打响“保命战”

Core Viewpoint - A significant number of traditional Chinese medicine (TCM) products are at risk of being eliminated from the market due to new regulatory requirements that will take effect in July 2026, which mandate clearer safety information in product descriptions [3][10]. Industry Overview - The new regulations, effective from July 2023, require that any TCM product with unclear safety information (labeled as "unclear") will not be eligible for re-registration after July 1, 2026 [3][10]. - Approximately 75% of TCM products currently on the market have safety information marked as "unclear," which poses a substantial risk of elimination for these products [5][10]. Market Impact - The impending regulatory changes are expected to lead to a significant reshuffling of market shares within the TCM industry, as many companies may not be able to meet the new requirements [10][11]. - Notable products facing potential withdrawal include those with substantial sales figures, such as Longmu Bone Strengthening Granules, which is projected to exceed 1 billion yuan in retail sales in 2024 but has unclear safety information [7][10]. Regulatory Context - The regulatory changes aim to enhance the quality of TCM products rather than a blanket elimination of all products, allowing companies to submit additional research and safety reports to comply [10][12]. - The policy encourages companies to invest in research and development to clarify the efficacy and safety of their products, thereby improving the overall scientific standards of TCM [12][13]. Future Developments - Many leading TCM companies have already begun to prepare for compliance with the new regulations, with some having successfully updated their product safety information [14]. - The regulatory framework is expected to foster a more competitive environment, potentially benefiting companies that can adapt and innovate while disadvantaging those that cannot meet the new standards [11][12].