浅析中国原料药登记现状及管理制度挑战——基于反垄断的视角

    Analysis of the Current Status of Active Pharmaceutical Ingredient Registration and Management System Challenges in China: An Antitrust Perspective

    • 摘要:
      目的  基于反垄断视角分析中国原料药登记现状及管理制度面临的挑战,探讨中国原料药领域垄断案件频发的原因与影响,并提出优化建议,以促进中国原料药行业公平竞争和药品供应稳定。
      方法 基于国家药品监督管理局公开数据、垄断案件统计数据,采用描述性统计分析及政策文本分析,系统研究中国原料药登记及管理制度现状、市场结构特征及垄断行为诱因。
      结果 截至2024年底,中国48.4%的已批准原料药品种由不超过3家企业生产,24.7%为独家生产;39.9%的原料药需求者数量高于供给者(平均比率4.1倍),垄断案件频发主因包括准入壁垒高、权属不清、供应链权力结构失衡等,导致价格暴涨、研发能力削弱和药品供应不稳定。
      结论 建议明确原料药产品所有权人、缩短“I状态”供应商变更审批时长、分类优化市场竞争环境,以期破解垄断困境,保障药品可及性与行业高质量发展。

       

      Abstract:
      OBJECTIVE  This study aims to analyze the current status of active pharmaceutical ingredient(API) registration and the challenges faced by the regulatory system in China from an antitrust perspective. It seeks to explore the reasons behind the frequent occurrence of monopoly cases in the API sector and their impacts, while proposing optimization recommendations to promote fair competition and ensure the stable drug supply in China's API industry.
      METHODS  Utilizing publicly available data from the National Medical Products Administration and monopoly-case statistics, this research employs descriptive statistical analysis and policy text analysis to systematically investigate the current state of API registration and regulatory systems, market structure characteristics, and the underlying causes of monopolistic behaviors.
      RESULTS  By the end of 2024, 48.4% of approved API varieties in China were produced by no more than three manufacturers, with 24.7% being exclusively produced by a single manufacturer. Additionally, 39.9% of API demand-side entities outnumbered suppliers, with an average ratio of 4.1∶1. The frequent occurrence of monopoly cases was primarily attributed to high entry barriers, unclear ownership, and imbalanced power structures within the supply chain, leading to price surges, weakened R&D capabilities, and unstable drug supply.
      CONCLUSION  To address the monopoly dilemma and ensure drug accessibility and high-quality industry development in China, it is recommended to clarify API product ownership, reduce the approval time for supplier changes under "I status", and optimize the market competitive environment through targeted classifications.

       

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