MAH(药品上市许可人)制度
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因生产劣药,这家药企被踢出集采
第一财经· 2025-10-15 08:46
Core Viewpoint - The article discusses the cancellation of the procurement qualification of Ningbo Dahongying Pharmaceutical Co., Ltd. for its fluorouracil injection due to quality violations, highlighting the increasing scrutiny on drug quality in the national centralized procurement process [3][4]. Group 1: Company Actions and Consequences - Ningbo Dahongying Pharmaceutical was found to have produced substandard fluorouracil injection, leading to administrative penalties including confiscation of illegal products and fines [3][4]. - The company, along with its contracted manufacturer Heilongjiang Fuhe Pharmaceutical Group, was placed on a violation list and banned from participating in national drug procurement activities from October 15, 2025, to April 14, 2027 [4][5]. - Dahongying Pharmaceutical was not the lowest bidder in the tenth batch of national drug procurement, with a bid price of 2.97 yuan per unit, indicating a relatively high price among the seven companies that won the bid [4][5]. Group 2: Industry Trends and Regulatory Environment - Since the implementation of the tenth batch of national drug procurement, there has been a trend of increased regulatory scrutiny on the production quality of selected drugs [5][6]. - As of now, four companies have been removed from the procurement list due to quality issues, with three of them being pure B-license enterprises, indicating a significant concern regarding the quality management of these companies [6][7]. - The article emphasizes the challenge for regulatory bodies to enforce stricter quality controls on pure B-license enterprises, which often lack direct production capabilities [8].