Core Viewpoint - The recent release of the "National Drug Centralized Procurement Document" by the National Organization for Drug Procurement has sparked widespread attention and discussion in the pharmaceutical industry, indicating a shift towards innovation-driven development rather than just low-cost generics [1] Group 1: Changes in Procurement Rules - The new procurement rules emphasize "rational pricing" rather than just "soulful price cuts," aiming to address previous concerns about extreme low pricing that could harm quality [2] - The introduction of a new price control mechanism based on "50% of the average price of shortlisted bids" instead of the lowest bid aims to prevent companies from quoting prices below cost [2][3] - A requirement for companies to submit a "Price Reasonableness Declaration" if their bid is below the anchor price is intended to ensure that pricing reflects actual costs and quality considerations [3] Group 2: Impact on Market Dynamics - The introduction of the "brand-based reporting mechanism" allows medical institutions to report expected usage by specific brands, aligning procurement more closely with clinical needs and reducing discrepancies between reported and actual demand [6] - The new rules are expected to enhance the precision and execution of procurement processes, addressing issues of inflated reporting and resource wastage [6] Group 3: Quality Control and Compliance - The new procurement rules raise the bar for quality control, requiring companies to have at least two years of experience in producing similar formulations and compliance with GMP standards [7] - The regulatory framework includes a "first report leniency" mechanism to encourage companies to report any irregularities, promoting a culture of compliance and transparency [8] - The National Medical Products Administration has achieved a 100% pass rate in drug inspections for key procurement varieties, indicating a strong focus on maintaining drug quality [8]
“反内卷”的风终于刮到了集采市场 低价中标事件还会再现吗
Hua Xia Shi Bao·2025-09-25 00:58