With the continuous deepening of the national institutional reform process, the social functions of drug regulatory departments have become increasingly prominent, and there is an urgent need to strengthen the implementation of responsibilities, improve the work framework system, and enhance the effectiveness of drug adverse reaction monitoring. Based on this, this article first introduces the importance of strengthening the monitoring of adverse drug reactions and analyzes the composition of the elements of adverse drug reaction monitoring. On the basis of exploring the current situation and difficult issues of adverse drug reaction monitoring by drug regulatory authorities, combined with relevant practical experience, this paper proposes methods and countermeasures for drug adverse reaction monitoring by drug regulatory authorities under institutional reform, including improving the establishment of monitoring institutions and strengthening the management of reporting units.