第十一批国家药品集采亮出新规则

Core Viewpoint - The National Organization for Drug Procurement has announced the selection criteria for the 11th batch of centralized procurement, emphasizing the exclusion of new drugs from the procurement process and setting a procurement threshold of 100 million yuan, aiming to enhance market scale and ensure drug quality and safety [1][2]. Group 1: Selection Criteria and Process - The selection for the 11th batch of centralized procurement includes 122 varieties, with 55 ultimately included after a three-stage screening process that considers the medical insurance directory and market scale [1][2]. - New drugs under negotiation with the medical insurance directory will not be included in the procurement, protecting industry innovation [2]. - The procurement scope has been expanded to include varieties with annual procurement amounts exceeding 100 million yuan from provincial platforms, enhancing the scale effect [2]. Group 2: Quality Assessment and Regulation - The threshold for bidding qualifications has been raised, requiring companies to demonstrate quality control capabilities to mitigate quality risks [3]. - Regulatory oversight will be strengthened, with comprehensive checks on selected enterprises and product sampling to ensure compliance with quality standards [3]. - Real-world efficacy assessments will be expanded, supporting high-level hospitals in conducting clinical efficacy studies of selected drugs [3]. Group 3: Reporting and Volume Rules - Medical institutions can report quantities based on specific brands, aligning their needs with the procurement results for smoother clinical transitions [4]. - Institutions are required to report a total quantity not less than 80% of actual usage, with allowances for adjustments based on clinical demand fluctuations [4]. - The agreed procurement volume will be set between 60% and 80% of reported quantities, with special considerations for certain high-risk drugs [4]. Group 4: Bidding Rules and Competition - Bidding rules have been optimized to prevent excessive internal competition, with adjustments to how price differences are calculated [5]. - A "low-price declaration" will be required from the lowest bidding company to justify their pricing and ensure it is not below cost [5]. - Measures to prevent collusion in bidding processes will be introduced, including leniency for companies that report collusion [5].