人工智能监管在药物开发中的未来:比较分析
Gabriela Lenarczyk1, Timo Minssen1, Nicholson Price1,2
1Center for Advanced Studies in Bioscience Innovation Law, Faculty of Law, University of Copenhagen, Karen Blixens Plads 16, 2300 Copenhagen, Denmark.
Journal of law and the biosciences
|November 12, 2025
概括
人工智能 (AI) 正在彻底改变药物开发,促使美国食品和药物管理局 (FDA) 和欧洲药品管理局 (EMA) 等监管机构适应. 这项研究分析了他们对人工智能监管的不同方法,强调了创新的挑战和机会.
科学领域:
- 监管科学 监管科学
- 人工智能在药物开发中的作用
- 制药政策 制药政策
背景情况:
- 人工智能 (AI) 越来越多地成为制药研究和开发的组成部分.
- 现有的监管框架正在适应人工智能驱动的药物发现和临床试验方面的进步.
- 包括美国食品和药物管理局 (FDA) 和欧洲药物管理局 (EMA) 在内的关键机构正在制定不同的AI监督方法.
研究的目的:
- 对FDA和EMA对AI在药物开发中的监管反应进行比较分析.
- 提出一个框架来理解美国和欧盟之间的监管分歧.
- 评估AI应用程序的成熟度,以在不断变化的政策环境中进行标准化监管.
主要方法:
- 对监管文件,行政命令和立法 (例如,欧盟人工智能法) 的比较分析.
- 开发一个分析框架,以对比FDA的对话驱动模式与EMA的风险分层方法.
- 检查跨药物开发阶段的AI应用:目标识别,生成化学和临床试验数字双胞胎.
主要成果:
- 美国食品和药物管理局采用灵活,个性化的评估模式,促进创新,但可能造成不确定性.
- 欧洲药物管理局采用结构化,分级风险的方法,提供可预测性,但可能会减缓早期采用.
- 在基于风险的原则上观察到趋同,但仍然存在重要的跨大西洋实施差异,受美国政策转变和国际合作减少的影响.
结论:
- 与欧洲更稳定的规则相比,美国的监管不确定性为人工智能在药物开发中带来了机遇和挑战.
- 不同的监管理念会影响制药行业人工智能创新的速度和可预测性.
- 需要协调努力来克服跨大西洋的差异,并促进全球人工智能驱动的药物开发.
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