新华鲜报丨更贴近患者！药品集采新规则发布

Core Points - The new rules for the 11th batch of national drug procurement aim to enhance the connection between pharmaceutical companies, hospitals, and patients, ensuring a balance between drug supply and demand [1][2] Group 1: Drug Procurement Adjustments - A total of 435 drugs are included in the new procurement rules, which have been in place for seven years, providing affordable and quality medications to the public [1] - Over 46,000 medical institutions participated in the new procurement, with nearly 80% specifying the required brands, indicating improved alignment between drug supply and clinical needs [2] - The agreed procurement volume for medical institutions is generally set at 80%, but for certain special categories, this will be reduced to 60%-70% [2] Group 2: Quality Control Enhancements - The new rules raise the quality standards for bidding companies, requiring at least two years of production experience for similar dosage forms and compliance with Good Manufacturing Practice (GMP) [4] - In cases of equal bids, preference will be given to companies with higher order volumes or those that have not undergone significant changes in production processes [4] Group 3: Anti-Collusion Measures - The rules address collusion by treating closely related companies as a single entity during bidding, and imposing strict penalties for collusion and bid-rigging [5] - A "first report leniency" mechanism is introduced, allowing companies that provide evidence of collusion to receive more lenient treatment [5] Group 4: Competition Regulation - New measures are implemented to prevent excessive competition, including setting a price anchor at 50% below the average winning bid for extremely low bids [7] - Each bidding company must commit to not quoting below their cost, and those with unreasonably low bids must justify their pricing [7] - The overall selection rate for the procurement remains stable at around 60%, with the potential for an increase due to the new revival rules [7]