第十一批国家药品集采文件发布 新增企业质量管控能力要求

Core Viewpoint - The National Healthcare Security Administration of China announced the 11th batch of centralized drug procurement, including 55 drug varieties, with bidding scheduled for October 21 in Shanghai. The procurement process emphasizes principles such as "stabilizing clinical use, ensuring quality, preventing collusion, and countering internal competition" [1] Group 1: Procurement Adjustments - The new procurement scheme allows medical institutions to report quantities based on specific brands rather than just generic names, aligning supply with clinical needs more effectively [1] - The procurement process aims to better respect clinical medication choices and address patient concerns regarding brand preferences [1] Group 2: Quality Control Requirements - New requirements for quality control have been introduced, mandating that bidding drug manufacturers or contract producers must have over two years of experience in producing similar formulations [1] - Bidding drugs must pass pre-market GMP compliance checks to mitigate quality risks associated with inexperienced manufacturers [1] Group 3: Selection Rules Changes - The selection rules have been significantly adjusted to avoid solely relying on the lowest bid, introducing a benchmark price that considers the higher value between 50% of the average comparable unit price and the lowest comparable unit price [1]