Abstract: Objective To inspire pharmaceutical manufacturers to actively monitor adverse drug reaction(ADR), and to raise their awareness of risk management. Methods By analyzing the current Decree of Management of Adverse Drug Reaction Report and Monitor and the new requirements of current work, including national system of Essential Medicines, safety reevaluation of traditional Chinese medicine injections, vaccine monitoring program, etc., as well as stating the importance of ADR monitoring and risk management, to clearly illustrate the legal obligation, duty and task of the manufacturers. Results and Condusion It is important to accelerate the manufacturers upgrading ADR monitoring and risk management levels to ensure drug safety for human beings and enterprises development sustainability.

Key words: pharmaceutical production company/enterprise, ADR monitoring, risk management