Abstract: OBJECTIVE To explore the methods to improve the monitoring of adverse drug reactions in Nanjing under the new situation of institutional reform. METHODS By analyzing the current situation of adverse drug reaction monitoring system in Nanjing, suggestions were put forward for the problems found. RESULTS Although the Nanjing monitoring system of adverse drug reaction had been basically established, it still needed to be continuously promoted and improved from the aspects of monitoring system establishment, monitoring evaluation ability and monitoring work level. CONCLUSION Drug safety is closely related to people's health, and the monitoring of adverse drug reactions is an important means of ensuring drug safety. The Nanjing drug regulatory department should continuously improve the monitoring of adverse drug reactions and cooperate with provincial adverse drug reaction monitoring agency to adapt to drug supervision under the new situation of institutional reform.