As a special commodity，medicine is directly related to the human health and the integrity of life. The government regulatory authorities play an important role in drug safety regulation. In light of the existing problems as the high occurrence rate and high severity of drug accidents，the regulatory authorities shall identify and control drug safety events as early as possible，which is helpful for the public health and construction of a harmonious society.

It is necessary to establish the drug safety early warning system，collect drug safety information with clear purposes and in a planed way，screen and analyze the drug safety incidents requiring different type of control，e.g. close concern，key monitoring or suspension of use；and prepare corresponding management plans and control measures to ensure drug safety early warning system works smoothly.

By means of introducing modern information techniques into information acquisition，information screening，evaluation management，centralized office and data resource management in early-warning management，it is possible to significantly improve the efficiency and effectiveness of the system.