中国药业2026，Vol.35Issue(6)：26-30,5.DOI:10.3969/j.issn.1006-4931.2026.06.006
人工智能用于药物研发领域的法律挑战与治理
Legal Challenges and Governance of Artificial Intelligence Applications in the Field of Drug Research and Development
摘要
Abstract
Objective To provide ideas and references for constructing a governance framework for artificial intelligence(AI)applications in the field of drug research and development that aligns with China's national conditions.Methods Application scenarios and technical characteristics of AI in the field of drug research and development were summarized,legal challenges existing in the application were analyzed,and countermeasures and suggestions for improving the legal governance of AI application in the field of drug research and development in China were proposed.Results Currently,AI applications in the field of drug research and development include ″structure-based drug design″,and its application include ″new drug discovery and design″,the core technologies/methods include ″analyzing protein three-dimensional structures,predicting drug-protein binding modes and affinities″,a total of eight categories.The legal challenges faced include compliance issues arising from unclear data ownership,protection of the dignity and autonomy of drug clinical trial participants,fairness and transparency of post-marketing drugs surveillance,as well as the attribution and accountability mechanisms for multiple responsible subjects.In response,legal governance can be continuously improved through measures such as constructing a system of governance principles,exploring paths for improving the legal framework,formulating optimization plans for the regulatory system,strengthening talent team building,and carrying out localized practices of international experience.Conclusion AI technology has significantly improved the efficiency of drug research and development.However,the disconnection between technological iteration and legal regulation has triggered multiple risks.Relevant laws and regulations should be further improved to standardize the process of AI application in drug research and development,ensure the integrity and security of data for pharmaceutical companies,and safeguard the rights and interests of parties involved in clinical trials.关键词
药物研发/人工智能/法律法规/治理框架Key words
drug research and development/artificial intelligence/laws and regulations/governance framework分类
医药卫生引用本文复制引用
秦华,于德志,张淳煕,黄鹏..人工智能用于药物研发领域的法律挑战与治理[J].中国药业,2026,35(6):26-30,5.基金项目
山东省济南市法治研究课题[济法办发[2025]1号,济司通[2024]32号]. （）
