关键词: 药品, 评价, 信号检测, 药物警戒

Abstract: Objective To analyze the definitions, sources, detection methods and evaluation principles of drug signal management at home and abroad, and to provide reference for standardizing pharmacovigilance of drug marketing authorization holders. Methods The signal management systems of US, EU, Japan and WHO were analyzed, and the methods of signal detection and evaluation were summarized. Results All the countries concerned had clear definitions of drug signals, established relatively standard processes of signal detection and evaluation, and formulated corresponding guidelines according to the supervision intensity and characteristics of each country. Signal detection methods were based on the collection of more related information while signal verification not only highlighted the collection of more related information, but focused on properties of drugs, characteristics of patients and similar cases so as to make a more reliable judgment. In order to improve the efficiency of signal detection, prioritization was emphasized in the process of determining the nature of information in order to put more resources into the study on the potential risks that might affect the risk-benefit ratio. Conclusions ignal detection in pharmacovigilance in China has just started, so there is the pressing need to promote international exchange and cooperation, and steadily improve the competence of professionals of signal detection in China.

Key words: drug, evaluation, signal detection, pharmacovigilance