摘要
近年来,以大语言模型为代表的人工智能(AI)技术快速发展,为各行业智能化转型提供了新的技术支撑。本文从技术与业务适配性的角度出发,分析了当前药品监管领域智能化面临的挑战、AI技术在药品监管业务中的应用潜力以及AI技术与药品监管业务的融合方法。通过国内外典型案例研究,重点探讨了在药品监管领域辅助审批、日常监管、公众服务和决策支持等关键业务场景AI赋能的技术路径及应用效果。得出AI技术可显著提升监管效率,但需解决数据安全、业务适配等关键问题的结论,并提出构建国家级药品监管大语言模型平台、完善协同创新机制等思考,为推进药品监管智能化转型提供参考。
In recent years,artificial intelligence(AI)technologies,represented by large language models,have developed rapidly,providing new technical support for the intelligent transformation of various industries.This paper analyzes the challenges currently faced in the field of drug regulation,the potential applications of AI technologies in regulatory operations,and methods for integrating AI with drug regulatory processes,from the perspective of technical and business adaptability.Based on domestic and international case studies,it focuses on the technological pathways and practical outcomes of AI empowerment in key business scenarios,such as auxiliary approval,daily supervision,public services,and decision support.The study concludes that AI technologies can significantly improve regulatory efficiency,but key challenges,such as data security and business adaptation,need to be addressed.Recommendations include establishing a national-level AI-based regulatory platform and improving collaborative innovation mechanisms,providing references for advancing the intelligent transformation of drug regulation.
作者
吴欣然
刘洋
Wu Xin-ran;LIU Yang(Center for Information,NMPA)
出处
《中国食品药品监管》
2025年第9期30-39,共10页
China Food & Drug Administration Magazine
基金
2024年中国药品监督管理研究会课题(2024-Y-Y-019)。
关键词
药品监管
人工智能
大语言模型
应用场景
检索增强生成
pharmaceutical regulation
artificial intelligence
large language models
application scenarios
retrieval-augmented generation
