Analysis of the Current Application Status and Enlightenment of Artificial Intelligence in Post-marketing Pharmacovigilance in China
10.3870/j.issn.1004-0781.2025.04.010
- VernacularTitle:人工智能在我国上市后药物警戒中的应用现状分析和启示
- Author:
Tao WANG
1
;
Lin ZHANG
;
Qing WANG
;
Pengcheng LIU
;
Chuanyong SHEN
Author Information
1. 国家药品监督管理局药品评价中心,国家药品监督管理局药物警戒研究与评价重点实验室,北京 100022
- Publication Type:Journal Article
- Keywords:
Artificial intelligence(AI);
Machine learning(ML);
Pharmacovigilance;
Individual case safety reports(ICSRs);
Post-marketing regulation
- From:
Herald of Medicine
2025;44(4):560-564
- CountryChina
- Language:Chinese
-
Abstract:
Objective Pharmacovigilance,as an essential component of post-marketing drug regulation,plays a crucial role in ensuring the safety of public medication use.In recent years,Artificial intelligence(AI)technology,with its powerful data processing and analysis capabilities,has shown tremendous potential in the field of Pharmacovigilance.This article introduced and analyzed the application background of AI technology in Pharmacovigilance,its exploration and current status both internationally and within China,highlighted its application in the country,as well as the associated problems and challenges from the perspective of post-marketing regulation.It aims to provide reference for post-marketing regulation in China.Currently,China's exploration and application of AI in pharmacovigilance have just begun,and efforts should be intensified and the pace accelerated.Regulatory agencies should actively develop and implement regulatory standards or relevant guidelines for AI technologies throughout the product lifecycle,strengthen personnel training,talent cultivation,and introduction,actively promote close cooperation among regulatory agencies,pharmaceutical companies,research institutes,and universities,and jointly promote the innovative application of AI technology in the field of drug regulation.
