第十一批国家组织药品集采启动：55个品种纳入报量范围，新规引导“质价双优”

Core Points - The National Medical Insurance Administration has officially launched the 11th batch of centralized procurement, including 55 drug varieties after a rigorous three-stage selection process [1][2] - This batch introduces a new sales threshold of 100 million yuan, excluding 24 varieties with sales below this threshold, reflecting a focus on drug quality and innovation [1][2] - The selection process emphasizes intellectual property protection, excluding drugs with unexpired patents and those with high clinical risks [2][3] Selection Criteria - A total of 122 candidate varieties were initially screened, with 55 ultimately selected based on criteria such as market scale, clinical expert opinions, and risk assessments [2][3] - Selected drugs cover various therapeutic areas, including anti-infectives, anti-tumor, diabetes, and cardiovascular medications [2] - Specific selection criteria include having at least seven companies for reference formulations and a procurement amount exceeding 100 million yuan in 2024 [2][3] Quality Control Measures - The new procurement rules raise the qualification requirements for bidders, mandating at least two years of production experience for the drug's manufacturing entity [3] - The National Medical Products Administration will implement comprehensive inspections and product sampling to ensure the quality of selected drugs [3][4] - In 2024, the administration aims for 100% coverage of selected varieties and enterprises through a combination of national and local sampling [3][4] Reporting and Quoting Adjustments - The new rules allow medical institutions to report quantities based on specific brands rather than generic names, aligning supply with clinical needs [4][5] - Institutions are required to report quantities that are at least 80% of actual usage, with flexibility for adjustments based on clinical demand [4][5] - The procurement process will also address irrational low-price competition and supply risks through updated bidding rules and penalties [5][6] Policy Evolution - The 11th batch of procurement marks a shift from a focus solely on low prices to a dual emphasis on quality and price [7] - The centralized procurement initiative has been ongoing for seven years, covering 435 drug varieties and significantly reducing drug prices for the public [7]