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国家医保局明确了,55种药品拟纳入第11批集采范围
21世纪经济报道· 2025-08-06 04:47
Core Viewpoint - The article discusses the ongoing optimization of China's drug procurement policy, emphasizing the principles of "stabilizing clinical use, ensuring quality, preventing collusion, and avoiding internal competition" as the country moves into its eleventh round of drug procurement, which includes 55 drugs [1][6][10]. Group 1: Drug Procurement Overview - Since 2018, China has conducted ten rounds of drug procurement, covering 435 drugs, with the eleventh round now initiated [1][6]. - The National Medical Insurance Administration (NMI) has stated that 480 companies submitted information for the procurement process, with an average of 15 companies per drug, and some drugs having over 40 companies participating [1][6]. Group 2: Optimization Measures - The NMI has optimized procurement rules, including allowing medical institutions to specify brands in their volume reporting and changing the price difference calculation method to not solely rely on the lowest bid [6][10]. - Quality assurance measures have been heightened, requiring that bidding companies have no violations of Good Manufacturing Practices (GMP) in the past two years [6][10]. Group 3: Market Impact - The eleventh batch includes a variety of drug forms, with oral sustained-release and injection drugs making up significant portions of the list [6][7]. - Notable drugs include cefazolin and famotidine, with over 30 companies eligible for bidding, indicating high competition [7]. Group 4: Financial Implications - The procurement process has saved approximately 440 billion yuan in medical insurance funds since 2018, with over 360 billion yuan saved from negotiations on older drugs, which has been redirected to innovative drugs [10]. - The shift in procurement policy is moving from a focus on low prices to a model that emphasizes quality, cost control, and reasonable profits [10][11]. Group 5: Regulatory Developments - The NMI is committed to maintaining a transparent and fair procurement process, with ongoing efforts to address issues of price fairness and quality assurance in the pharmaceutical industry [12].
480家药企竞逐第十一批集采,国家医保局强调理性报价
Core Viewpoint - The National Medical Insurance Administration (NMIA) is advancing the 11th batch of drug procurement, focusing on maintaining clinical stability, ensuring quality, preventing collusion, and avoiding excessive competition in the pharmaceutical industry [1][2][6]. Group 1: Drug Procurement Process - Since 2018, the NMIA has successfully conducted ten batches of drug procurement, covering 435 types of drugs, with the 11th batch now underway [1][2]. - The 11th batch includes 55 drugs, with an average of 15 companies per drug, and some drugs having over 40 companies participating [1][3]. - The procurement process aims to optimize price calculations and ensure that the lowest bid is justified and does not fall below production costs [3][6]. Group 2: Market Impact and Drug Types - The 11th batch primarily includes oral sustained-release and injection forms, with 41.8% being oral forms and 40% being injections [3]. - Notable drugs in this batch include cefazolin, famotidine, and various oral sustained-release formulations, with some expected to exceed sales of 1 billion yuan [4][5]. - The NMIA has reported that the cumulative savings from drug procurement since 2018 amount to approximately 440 billion yuan, with over 360 billion yuan allocated for negotiated drug use [5][6]. Group 3: Regulatory and Quality Assurance - The NMIA emphasizes the importance of quality assurance, requiring that selected drugs have not violated production quality standards in the past two years [3][6]. - The regulatory framework has shifted from merely controlling costs to fostering a healthy industry ecosystem that prioritizes quality and reasonable profits [6][8]. - The NMIA is implementing stricter monitoring and evaluation measures for companies involved in drug procurement to ensure compliance and quality [6][7]. Group 4: Future Directions - The NMIA plans to continue normalizing and institutionalizing drug procurement, aiming to include all clinically necessary and reliable drugs in the procurement scope [8][9]. - Future reforms will focus on enhancing quality supervision throughout the drug lifecycle and improving communication among hospitals, insurance, and regulatory bodies [8][9].