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中国医药导刊 ›› 2025, Vol. 27 ›› Issue (4): 331-337.

• 监管科学 • 上一篇    下一篇

人工智能在药品开发及监管中的应用

徐莉, 李敏, 何伍*   

  1. 国家药品监督管理局药品审评中心,北京 100076
  • 收稿日期:2025-02-26 修回日期:2025-04-11 出版日期:2025-04-28 发布日期:2025-04-28

The Application of Artificial Intelligence in Drug Development and Regulation

  1. Center for Drug Evaluation National Medical Products Administration Beijing 100076, China
  • Received:2025-02-26 Revised:2025-04-11 Online:2025-04-28 Published:2025-04-28

摘要:

人工智能(AI)技术已广泛应用于药物开发及药品监管中,在提升药品开发速度并提高成功率,以及促进药品监管科学的发展方面产生深远影响。全球药品监管机构已通过立法、政策引导及技术合作生态构建,积极支持AI在药品生命周期中的应用。本研究系统探讨了AI在药物发现(包括靶点识别与选择、药物筛选与设计)、非临床研究、临床研究(包括方案设计、临床试验开展及数据收集与处理)、药品智能制造、药品上市后监测及药品监管6个方面的应用,同时重点分析中国、美国及欧盟等国家和地区对AI监管的法规政策、行业规范、发展计划以及技术指南等,概述目前AI在药品监管机构的落地应用现状,并基于以上内容,从政策设计、监管体系构建与监管思路,以及技术要求、当下面临的挑战及应对策略等方面提出思考,旨在为医药行业提供“技术-监管”协同发展的策略参考,助力实现从药物发现到患者用药安全的全链条智能升级,促进医药创新与发展。


关键词: 人工智能, 药品监管, 药物发现, 临床

Abstract:

Artificial intelligence AI technology has been widely applied in drug development and regulation profoundly enhancing the speed and success rate of drug development while promoting the advancement of regulatory science. Global drug regulatory agencies have actively supported AI applications throughout the drug lifecycle through legislation policy guidance and the establishment of technical cooperation ecosystems. This study systematically discussed the application of AI in six aspects drug discovery including target identification and selection as well as drug screening and design), non-clinical research clinical research including protocol design clinical trial execution and data collection/processing), intelligent drug manufacturing post-marketing surveillance and drug supervision. It particularly analyzes the regulatory frameworks industry standards development plans and technical guidelines for AI governance in China the United States and the European Union outlining the current application status of AI in regulatory agencies. Based on the above analysis this study proposes strategic considerations regarding policy design regulatory system construction compliance approaches technical requirements current challenges and countermeasures. It aims to provide a strategic reference for the "technology-regulation" collaborative development facilitate intelligent upgrades across the entire chain from drug discovery to patient medication safety thereby foster pharmaceutical innovation and advancement.


Key words:  , Artificial Intelligence , Drug Regulation , Drug Discovery , Clinical

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