Abstract: Objective To introduce the relevant content and application cases of the US sentinel system, so as to provide reference for the safety monitoring of medical products in China. Methods The background, organizational framework, safety risk signal elements and evaluation process of the US FDA sentinel system were introduced, and the evaluation of renin-angiotensin-aldosterone system(RAAS) related drugs and angioedema signals were taken as an example to provide reference for the establishment of a complete electronic database monitoring system in China. Results and Conclusion On the basis of the Chinese Hospital Pharmacovigilance System (CHPS) platform, the number of sentinel surveillance areas and the number of sentinel units continue to be expanded, and active monitoring of adverse reactions is actively carried out. At the same time, explore and develop new data management models to support data processing and analysis.

Key words: US FDA, sentinel system, angioedema