集采“反内卷”新规落地 国家“团购”切实守护民众用药质量安全

Core Viewpoint - The recent announcement by the National Organization for Drug Procurement emphasizes principles of "stabilizing clinical use, ensuring quality, preventing collusion, and countering excessive competition" in the 11th round of national drug centralized procurement [1] Group 1: Procurement Process - A total of 46,000 medical institutions participated in this centralized procurement, allowing them to report quantities based on clinical needs and medication habits, either by generic name or specific brand [1] - The new procurement rules impose higher quality control standards on bidding companies, requiring at least two years of production experience for similar dosage forms [3] - The procurement process will no longer simply select the lowest bid; each bidding company must commit to a price not lower than their cost, and those bidding below 50% of the average entry price must explain the rationale behind their pricing [3] Group 2: Quality Assurance - The new rules aim to combat collusion and the practice of winning bids with unreasonably low prices, which could compromise quality [5] - There are concerns that cost-saving measures, such as changing raw materials and packaging, may lead to a decline in drug quality, making quality assurance measures crucial [7] - Selected products and companies will undergo comprehensive random inspections, and any changes in raw materials or production processes must be publicly disclosed [7] Group 3: Execution and Responsibilities - The procurement will strengthen the execution of selection results, making selected companies the primary responsible parties for supply assurance, requiring timely response to medical institution orders [8] - Medical institutions are expected to prioritize purchasing selected products and fulfill agreed procurement volumes and timely payment obligations [8]