Abstract: Objective To help drug manufacturers to understand and recognize the significance and their dominant position in the adverse drug reaction (ADR) monitoring work. Methods Based on the analysis of relevant regulations, the problems of the domestic drug manufacturers in ADR reporting and monitoring were analyzed, and related suggestions on how to develop and implement ADR reporting and monitoring were put forward. Results and Conclusion Drug manufacturers should strengthen their cognition and understanding of ADR monitoring and reporting, structure the quality management system, set up expert organizations and full-time personnel responsible for ADR monitoring. At the same time, drug manufacturers should strengthen their internal training to commit the responsibility of “drug safety first person” actively.

Key words: drug manufacturer, post-marketing study , the first person responsible