集采规则新变：不再简单选用最低报价，新增“未入围复活”

Core Viewpoint - The newly released National Drug Centralized Procurement Document emphasizes principles such as ensuring clinical needs, maintaining quality, preventing collusion, and avoiding excessive competition in drug procurement [1][2]. Group 1: Changes in Procurement Rules - The new procurement rules allow medical institutions to report drug quantities either by brand or by generic name, enhancing the match between clinical demand and supply [1][2]. - A new "revival for non-selected" rule has been introduced, allowing companies that did not initially qualify to enter the selection process if they meet specific criteria, including sufficient reporting from hospitals and a willingness to lower prices [2][3]. - The procurement process will focus more on ensuring the supply of pediatric medications, with adjusted pricing rules for small specifications suitable for children [3]. Group 2: Quality Assurance Measures - New qualification requirements for bidders include having at least two years of production experience and ensuring that the production line has passed GMP compliance checks [4][5]. - The selection process will prioritize companies with stable quality and a history of no significant changes in production processes or raw materials [5]. Group 3: Anti-Collusion Measures - The procurement rules include strict measures against collusion, such as treating related companies as a single entity during bidding and introducing a "first to report" mechanism for whistleblowers [6]. - Companies involved in collusion will face severe penalties, including being placed on a violation list and subjected to strict regulatory actions [6]. Group 4: Pricing Strategy Adjustments - The new rules aim to prevent extreme low pricing by optimizing the highest effective bid formation rules and adjusting the price control anchor to avoid excessively low bids [9][10]. - Companies are required to justify any bids below the established price anchor, ensuring that pricing remains reasonable and reflective of actual costs [10].