不良反应等尚不明确的中成药或被调出医保

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's payment capacity and drug supply situation [1][7]. Group 1: Drug List Adjustment Principles - The adjustment will adhere to the principles of steady progress and continuous optimization, emphasizing transparency and scientific evaluation in the review process [1][5]. - Traditional Chinese medicine (TCM) products with unclear adverse reactions will be prioritized for removal from the list [1][7]. Group 2: Reference Drug Communication Method - The NHSA has introduced a trial method for reference drug communication, which will allow for the selection of reference drugs to assess the value of new drug applications [3][5]. - This method aims to enhance the preparation of economic and clinical data by allowing early application for reference drug determination [5]. Group 3: Focus on Traditional Chinese Medicine - TCM products will be a key focus in the upcoming adjustments, particularly those with "unclear" labels in their instructions regarding contraindications and adverse reactions [5][7]. - From July 1, 2026, TCM products with unclear safety information will not be approved for re-registration, impacting those already on the list [5][11]. Group 4: Increase in Drug Applications - The number of drug applications for the National Medical Insurance Drug List has surged, with a projected increase of 30% to 40% in 2025 compared to 2024, and further growth expected in 2026 [6]. - The rapid approval of innovative drugs, with 76 new first-class innovative drugs approved in 2025, contributes to this increase [6]. Group 5: Regulatory Trends and Challenges - The tightening of regulations around TCM products indicates a rising barrier to entry, with a focus on eliminating products that lack clinical efficacy and have unclear safety profiles [11][12]. - The NHSA has been actively conducting price governance actions against TCM products that are overpriced without unique therapeutic effects, leading to their potential exclusion from reimbursement [12].