关键词: font-size:medium, ">药物警戒；安全性信号；信号检测；监管机构；制药企业

Abstract: Drug safety signal detection is an essential activity of pharmacovigilance (PV)， which is the basis for understanding the safety profiles and risk characteristics of drugs and vaccines. Long-term and continuous detection of drug safety signals is the key for ensuring the safety of medicinal products. Compared with that in Europe and North America， the work of drug safety signal detection in China started relatively late. How to accurately understand and execute drug safety signal detection is the key and difficult point in pharmacovigilance. Therefore， it is an important and urgent task to fully utilize the national adverse drug reaction safety database， pharmaceutical companies′ databases， and other relevant data to carry out passive surveillance and active surveillance for drug safety signal detection in China. This study summarizes the definition of drug safety signal， and the data sources， methods and processes of signal detection. With reference to the experience of developed countries and regions in Europe and North America， the responsibilities of regulatory authorities and pharmaceutical enterprises in drug safety signal detection and efficient cooperation mode are discussed. It is recommended that pharmaceutical enterprises continue to explore appropriate statistical methods to apply to the existing ADR databases with cooperation and communication with regulatory agencies. It is recommended that regulatory authorities and pharmaceutical enterprises actively collaborate in drug safety signal detection and jointly share the responsibility for monitoring the safety of drugs/vaccines.

Key words: font-size:medium, ">Pharmacovigilance； Safety signal； Signal detection； Regulatory authorities； Pharmaceutical enterprises