Abstract: Objective To analyze the current pharmacovigilance system policies in South Korea and give advice on the construction of pharmacovigilance systems in China. Methods By analyzing the organizational system, laws and regulations, and the monitoring and reporting system in South Korea, and comparing them with those in China, it was possible to provide reference for the construction of more effective pharmacovigilance systems in China by optimizing the functions of technical institutions for pharmacovigilance, improving the pharmacovigilance reporting system, and ensuring rational drug use. Results and Conclusion According to the newly revised pharmaceutical law, South Korea established the Institute of Drug Safety and Risk Management, improved the monitoring and reporting system of pharmacovigilance. China should optimize the functions of technical institutions for pharmacovigilance, improve the reporting system of pharmacovigilance, and assess the rationality of drug use.

Key words: pharmacovigilance, South Korea, system, adverse drug reaction, monitoring