不良反应等“尚不明确”的中成药或将被调出医保目录

Core Viewpoint - The National Healthcare Security Administration (NHSA) is set to adjust the National Medical Insurance Drug List in 2026, focusing on optimizing the review process and ensuring alignment with the current healthcare fund capabilities and drug supply conditions [1][4]. Group 1: Drug List Adjustment - The adjustment will prioritize Traditional Chinese Medicine (TCM) that has unclear adverse reactions, which will be targeted for removal from the list [1][3]. - The NHSA emphasizes a transparent and scientific review process, enhancing public communication regarding the adjustment logic and evaluation criteria [1][2]. Group 2: Reference Drug Communication - The NHSA has introduced a "Reference Drug Communication Method" to optimize the evaluation rules, allowing innovative drugs to apply for reference drug status earlier in the process [2][4]. - The selection of reference drugs will now occur before the traditional evaluation phase, enabling companies to prepare more comprehensive economic and clinical data [2][3]. Group 3: Focus on Traditional Chinese Medicine - TCM drugs with "unclear" labels regarding contraindications and adverse reactions will face stricter scrutiny, with new applications likely to be denied if such issues are present [3][5]. - A significant increase in drug applications is expected, with a 30% to 40% rise in 2025 compared to 2024, driven by a large existing drug inventory and accelerated approvals of innovative drugs [3][6]. Group 4: Regulatory Measures and Market Dynamics - The NHSA's ongoing efforts to regulate TCM include a focus on improving the quality of drug labels and ensuring that outdated or ineffective drugs are phased out [6][8]. - High-priced TCM products lacking unique therapeutic effects will be increasingly excluded from the market, as the NHSA has initiated multiple price governance actions [9].