Abstract: Adverse drug reaction(ADR) monitoring is the front line of drug administration especially of drug safety administration. It is the important responsibility of government to assure the drug safe usE on the public and promote the rational use. At the same time it is the signal of the level on drug administration and social progress. After over 20 years of ADR monitoring in China, the new Regulation for the Administration of Adverse Drug Reaction Reporting and Monitoring is published and come into effect. This article reviews the past, analyses the present, prospects the future, and marks the whole ADR monitoring into three phases the primary period, the developing period and the developed period in accordance with the increasing and transfer of the key ability of ADR monitoring. We think that the current ADR monitoring practice has completed the establishment of the primary period, and now is entering the developing period whose important character is to enhance the ability of reevaluation.

Key words: adverse drug reaction monitoring, technical development period