The applications and advances of artificial intelligence in drug regulation:A global perspective  

作　　者：Lixia Fu Guoshu Jia Zhenming Liu Xiaocong Pang Yimin Cui 

机构地区：[1]Institute of Clinical Pharmacology,Peking University First Hospital,Beijing 100034,China [2]Department of Pharmacy,Peking University First Hospital,Beijing 100034,China [3]State Key Laboratory of Natural and Biomimetic Drugs,School of Pharmaceutical Sciences,Peking University,Beijing 100191,China [4]Department of Pharmacy Administration and Clinical Pharmacy,School of Pharmaceutical Sciences,Peking University,Beijing 100191,China

出　　处：《Acta Pharmaceutica Sinica B》2025年第1期1-14,共14页药学学报(英文版)

摘　　要：Artificial intelligence(AI)has emerged as a transformative force in healthcare,with applications spanning diagnostics to drug development.However,its integration into drug regulation remains nascent,with varying degrees of adoption and implementation across different regulatory bodies worldwide.This review aims to provide a comprehensive overview of the current state of AI in drug regulation,encapsulating AI-related policies,initiatives,and its practical application in regulatory agencies globally.It further discusses the challenges and future prospects of AI in this field.The findings reveal that numerous agencies have launched action plans and initiatives to incorporate AI,aiming to streamline regulatory processes and enhance data-driven regulatory decision-making.Moreover,AI’s deployment in safety surveillance,workflow optimization,and regulatory science research is expanding,highlighting its increasing impact on drug regulation.Nonetheless,key challenges persist,such as data quality and reliability,technical limitations,talent shortage and the absence of standards.The review concludes that interdisciplinary collaboration is crucial to harness AI’s full potential in drug regulation and overcoming its current limitations.In the future,AI may become a pivotal catalyst in drug regulation,promising a new era of enhanced scrutiny,efficiency,and innovation that will benefit public health on a global scale.

关 键 词：Artificial intelligence Machine learning Regulatory science Safety surveillance PHARMACOVIGILANCE REGULATION Emerging technology 

分 类 号：TP3[自动化与计算机技术—计算机科学与技术]