开标时间地点都定了，一文读懂第11批集采新规则

Core Insights - The core change in the 11th batch of national drug centralized procurement is prioritizing clinical needs over lowest price bidding, with new rules aimed at optimizing the procurement process [1][3]. Group 1: Procurement Rules - The 11th batch of centralized procurement will open for bidding on October 21, 2025, with submissions accepted from 7:30 AM to 10:00 AM [1]. - The procurement document allows medical institutions to report quantities based on either generic names or specific brands, with 77% of the 46,000 participating institutions opting for brand-specific reporting [3]. Group 2: Quality Assurance - New qualification requirements for bidding companies include having at least two years of production experience for similar formulations, compliance with GMP standards, and no GMP violations in the past two years [5]. Group 3: Anti-Collusion Measures - Measures to prevent collusion include treating closely related companies as a single entity during bidding and introducing a leniency mechanism for whistleblowers who provide evidence of collusion [5]. Group 4: Anti-Internal Competition - The rules have been adjusted to prevent extreme price undercutting, with a new pricing anchor set at 50% of the average winning bid if the lowest bid is below that threshold [6]. - A simulation of previous bidding rounds indicated that about 25% of products would see an average price increase of 34% under the new rules, with some products potentially increasing by up to 170% [6]. Group 5: Execution and Compliance - Selected companies are now responsible for ensuring supply and timely delivery, while medical institutions are required to prioritize purchasing selected products and adhere to payment obligations [6]. - The overall selection rate for the 11th batch is expected to stabilize around 60%, with a new rule allowing for the revival of previously non-selected bids, potentially increasing the actual selection rate [6].