Core Viewpoint - The National Organization for Drug Procurement has initiated the 11th batch of centralized drug procurement, allowing medical institutions to report their demand from August 6 to 25, with a focus on optimizing reporting rules and ensuring accurate demand submissions [1][2][3]. Group 1: Procurement Process - The procurement process allows medical institutions to report demand by generic name or specific brand, encouraging participation from recognized companies [1]. - A total of 480 companies submitted relevant drug information, with an average of 15 companies per proposed procurement variety, and some varieties having over 40 companies participating [1]. Group 2: Reporting Requirements - Medical institutions are required to report annual demand for each variety at no less than 80% of the average usage for 2023-2024, with allowances for written explanations in cases of significant demand reduction [1][2]. - The reporting system includes specific annotations for essential drugs and pediatric formulations, allowing institutions to determine conversion ratios if necessary [2]. Group 3: Policy Clarifications - The National Medical Insurance Administration has clarified that while institutions should prioritize selected procurement drugs, they are not restricted to only using these drugs, with 60%-80% of reported demand typically covered by selected drugs [3]. - Historical data indicates that over 80% of medical institutions continue to use selected drugs even after fulfilling their procurement agreements, reflecting a high level of acceptance [3].

Core Points - The National Drug Procurement Office has initiated the 11th batch of centralized drug procurement, with a demand reporting period from August 6 to 25, 2023 [1] - A total of 480 companies submitted drug information, with an average of 15 companies per drug type among the 55 proposed procurement varieties [1] - The procurement process allows medical institutions to report demand based on generic names or specific brands, encouraging participation from recognized companies [1][2] - Medical institutions are required to report demand accurately, with a minimum annual demand of 80% of the average usage for 2023-2024 [1] - The reporting system accommodates basic drugs and pediatric medications, allowing institutions to determine conversion ratios if necessary [2] - The National Healthcare Security Administration clarified that while institutions should prioritize selected drugs, they are not restricted to only using them, with 60%-80% of reported demand typically covered by selected drugs [3] - Historical data indicates that over 80% of institutions continue to use selected drugs even after fulfilling their procurement agreements [3] Summary by Sections Procurement Process - The 11th batch of centralized drug procurement is being organized, with a focus on accurate demand reporting from medical institutions [1] - 480 companies have submitted relevant drug information, indicating a competitive environment for the procurement process [1] Reporting Requirements - Medical institutions can report demand based on generic names or specific brands, enhancing flexibility in the procurement process [1][2] - Institutions must report a minimum of 80% of the average annual usage for the upcoming years, ensuring realistic demand assessments [1] Policy Clarifications - The procurement policy allows for adjustments based on clinical needs, particularly for basic and pediatric medications [2] - Institutions are encouraged to prioritize selected drugs but are permitted to procure non-selected drugs as needed, reflecting a balanced approach to drug availability [3]

Group 1 - The core idea of the new centralized drug procurement policy emphasizes "no procurement for new drugs, and new drugs are not included in procurement" to protect industry innovation and ensure reasonable returns for innovative drugs during their initial market period [1][2] - The new procurement rules will not use the lowest price as a reference, which aims to avoid the elimination of normal-priced companies and is expected to increase the average price level of selected drugs [2] - The procurement process respects clinical needs by allowing pharmacies to participate, thus broadening the sales channels for procured drugs and enhancing accessibility for patients [3] Group 2 - The selection of drugs for procurement focuses on those with procurement amounts exceeding 100 million yuan in 2024, allowing companies more time to develop and cultivate the market [1] - A mechanism has been introduced to allow non-selected companies to "revive" their bids by lowering prices, promoting rational competition among enterprises [2] - Special consideration has been given to children's medications by creating an independent grouping, which aims to improve the accessibility of these essential drugs [3]

8月7日，据国家医保局消息，第十一批国家组织药品集采报量正式启动，国家组织药品联合采购办公室 近日发布《关于组织医疗机构报送第十一批国家组织药品集中采购品种需求量的通知》，于8月6日—25 日开展第十一批药品集采医疗机构需求量填报工作。本次集采共涉及55个品种，与以往相比，本次报量 规则进行多项优化，首次允许医疗机构可按厂牌报量，同时设定了科学的报量基准，并对基本药物、儿 童用药等特殊品类给予更灵活的政策空间，既保障临床用药需求，又推动药品供应市场良性竞争。 80%报量基准 "反内卷"是第十一批集采的重要原则，包括报量在内的规则也在不断优化。此前，药品集采是按照整个 品种进行报量，不区分厂牌，本次集采报量首次允许医疗机构按厂牌报量。医疗机构可不区分厂牌、按 通用名填报每个品种的需求量，也可以细化到具体厂牌，引导医疗机构认可度高的企业积极参与。 国家医保局相关负责人指出，医疗机构可根据实际需求自主选择按品种报量或按厂牌报量，也可以部分 需求量按品种报、部分需求量按厂牌报。如果选择按厂牌报量，不限制具体厂牌数量。 华东某上市药企相关负责人告诉北京商报记者，第十一批集采明确提出"反内卷"，核心是避免企业恶性 低价竞 ...

Core Viewpoint - The article discusses the recent announcement by the National Organization for Drug Procurement regarding the 11th batch of centralized drug procurement, highlighting the new reporting requirements and rules for medical institutions [1]. Group 1: Reporting Characteristics - Medical institutions can report demand by brand name or by generic name, allowing for greater flexibility in participation [1]. - Accurate reporting is emphasized, with a requirement that each institution's reported annual demand for each product should not be less than 80% of the average usage for 2023-2024 [1]. - The reporting system is designed to align with policies on essential medicines and pediatric medications, allowing institutions to report based on actual needs if certain conditions are met [1]. Group 2: Brand Selection and Reporting Process - The selection of brands available for reporting is based on prior submissions from companies that have provided relevant drug information [3]. - Institutions can choose to report demand either by product type or by brand, with no limit on the number of brands selected [4]. - The reporting system automatically calculates whether the reported demand meets the historical procurement volume requirement of 80% [5]. Group 3: Special Considerations - Institutions facing challenges in meeting the 80% requirement due to special circumstances can submit explanations for reduced reporting [6]. - For unapproved specifications and essential medicines, institutions can determine their own reporting ratios based on clinical needs [7]. - Special considerations are made for pediatric formulations, allowing institutions to report based on actual needs if certain formulations have not passed consistency evaluations [8]. Group 4: Participation and Compliance - The procurement process allows for participation from private medical institutions and retail pharmacies, promoting access to quality medicines [12]. - Institutions are encouraged to prioritize the use of selected drugs while still having the option to procure non-selected products for remaining needs [10][11]. - The article outlines the process for new users to register and for existing users to recover their accounts [13].

三是与基本药物、儿童用药等政策保持衔接。对于基本药物规格，报量系统中专门作出标注，如该规格 未通过质量和疗效一致性评价，医疗机构可自行确定折算比例，并在报量时作出说明。对于儿童适宜品 规，如未通过一致性评价，医疗机构认为难以替代、报量无法折算的，可根据实际需要报量并作出说 明。 一是医疗机构可按厂牌报量。本次集采优化了报量规则，医疗机构可不区分厂牌、按通用名填报每个品 种的需求量，也可以细化到具体厂牌，引导医疗机构认可度高的企业积极参与。 二是要求医疗机构如实准确报量。报量是带量采购的基础环节，本次集采原则上要求每家医疗机构每个 品种的年需求量不低于2023-2024年度平均使用量的80%。同时，对于存在临床需求明显减少、业务调 整等因素导致预期用量显著减少的，医疗机构可作出书面说明后按实际需求报量。 中新网8月7日电 据国家医保局微信公众号消息，近日，国家组织药品联合采购办公室发布《关于组织 医疗机构报送第十一批国家组织药品集中采购品种需求量的通知》，于8月6日至25日开展第十一批药品 集采医疗机构需求量填报工作。本次集采共涉及55个品种，报量工作主要有以下特点： ...

第十一批集采同一品种的申报企业最多达到了45家，超过第十批集采36家的纪录，市场竞争更加激烈。 对此，国家医保局特别提示企业要理性报价。 5日上午，国家医保局发布国家组织药品联合采购办公室（下称"药品联采办"）对第十一批集采药品信 息填报工作的最新统计结果，7月16日至31日，共480家企业提交了相关药品的资料信息，这些企业将作 为医疗机构填报需求量的选择范围。55个拟采购品种中，平均每个品种有15家企业，有3个品种的企业 超过40家，企业数最多的达45家。 2018年以来，国家层面已经开展了10批药品集采，覆盖了435种药品，近800家药企中选，涉及代表产品 2000余个。 针对第十批集采以来民众对部分仿制药的疗效存在疑虑以及担心过度竞争导致低价低质等社会关切的问 题，坚持"稳临床、保质量、防围标、反内卷"的原则，国务院常务会议研究通过了优化集采措施，优化 了具体的采购规则。 在中选规则方面，"新集采"为了引导理性竞争，防止过分内卷，优化了价差计算的"锚点"，不再以简单 的最低价作为参考，这样即使出现个别企业报低价，也不会影响其他正常报价的企业。同时报价最低企 业要公开说明报价的合理性，并承诺不低于成本报价 ...

Group 1 - The eleventh batch of centralized procurement has seen an increase in competition, with an average of 15 companies per product and a record 45 companies for the most competitive product [1][2] - A total of 480 companies submitted information for the procurement, indicating a high level of interest and participation in the process [1][3] - The top three products with the most applicants are Dihydrocodeine Injection (45 companies), Cefazolin Injection (43 companies), and Famotidine Injection (40 companies) [1][2] Group 2 - The new procurement rules aim to prevent excessive competition and ensure quality, with a focus on rational pricing and integrity in bidding [2][3] - The procurement process has been optimized to allow medical institutions to report demand based on specific brands, enhancing respect for clinical choices [5][6] - The National Healthcare Security Administration encourages qualified companies to participate and emphasizes the importance of rational pricing and ethical practices [2][6]

"新药不集采、集采非新药"是国家药品集采多年来坚持的原则。自2018年以来，国家已成功开展10 批药品集采，覆盖435种药品。第十一批集采继续聚焦上市多年、临床使用成熟的"老药"，更加关注群 众多层次、多元化用药需求。国家医保局相关司负责人说，本次集采与医保目录谈判相衔接，首次在品 种遴选时排除了通过谈判新进入医保且仍在协议期内的品种，旨在保护行业创新积极性。 在合理确定约定采购量方面，集采原则上要求报量总数不低于实际使用量的80%，但对于医疗机构 反映临床需求量减少，或因季节性、流行性疾病等需求量不稳定的，可由医疗机构作出说明后下调报 量。今年，将根据市场竞争格局、实际中选企业数等因素，把医疗机构报量的60%至80%作为约定采购 量，剩余部分仍由医疗机构自主选择品牌。对于抗菌药物、重点监控药品等特殊品种还会适当降低带量 比例，为临床用药留出更大选择空间。 在品种遴选上，此次集采以今年3月31日为品种遴选截止时间，沿用第十批集采的以"参比制剂和通 过质量和疗效一致性评价"的企业数量合计达到7家作为门槛，并进一步优化筛选条件。"截至今年3月31 日，共有122种药品满足初选条件。"国家组织药品联合采购办公室主任 ...

Core Viewpoint - The eleventh batch of national organized drug procurement has been initiated, focusing on 55 types of drugs, with an emphasis on ensuring quality, maintaining clinical stability, and preventing excessive competition in pricing [1][3]. Group 1: Procurement Process - The procurement process will enter the reporting phase for medical institutions, adhering to principles of "stabilizing clinical use, ensuring quality, preventing collusion, and avoiding excessive competition" [1]. - The selection of drugs for this batch will exclude newly negotiated drugs that are still under agreement, aiming to protect industry innovation [1][2]. - A total of 122 drugs met the initial selection criteria as of March 31, 2023, with 55 drugs ultimately selected for procurement after further filtering [2]. Group 2: Quality Assurance - Stricter quality requirements have been established, mandating that participating companies must have at least two years of production experience for similar formulations, and their production lines must not have violated quality management standards in the past two years [2][3]. - The procurement office will expand real-world research to support the clinical efficacy of selected drugs, encouraging comprehensive evaluations to enhance patient confidence in medication [2]. Group 3: Pricing and Competition - The procurement rules have been optimized to limit excessively low bids, requiring the lowest bidders to justify their pricing and ensure it does not fall below cost [3]. - The procurement will allow medical institutions to report specific brand quantities, aligning their needs with the selected results, which is expected to enhance the match between institutional demand and procurement outcomes [3][4]. Group 4: Procurement Volume - The total reported quantity for procurement is generally required to be no less than 80% of actual usage, with allowances for adjustments based on clinical demand fluctuations [4]. - The procurement strategy will focus on a range of 60% to 80% of reported quantities as agreed procurement volumes, with the remaining portion allowing for brand selection by medical institutions [4]. Group 5: Industry Impact - The ongoing optimization of procurement rules is expected to shift the industry focus from "low-price competition" to "quality competition, cost control, and reasonable profits," thereby promoting a more regulated industry order and improving the overall quality and accessibility of medications for the public [4].