关键词: 临床试验, 药物警戒, 智慧监管, 药品审评

Abstract: Pharmacovigilance is the scientific research and activity that detects， evaluates， understands and prevents various adverse reactions or problems related to drugs. Pharmacovigilance during clinical trials is an important part of the whole life cycle pharmacovigilance. While the clinical trial implied licensing system improves the review efficiency， how to establish pharmacovigilance during clinical trials to control safety risks and protect the subjects is worth further study. This paper introduced the legal and regulatory system construction and the information systerm construction of pharmacovigilance system during clinical trials， and summarized the effectiveness of pharmacovigilance system in monitoring safety report and the supervision of COVID-19 emergency varieties during clinical trials， and discussed the thinking of improving the intelligent supervision ability of pharmacovigilance during clinical trials， so as to provide reference for further improving the pharmacovigilance system during clinical trials in China.

Key words: Clinical trial； , Pharmacovigilance； , Intelligent supervision； , Drug review