To implement the relevant requirements of the reform of the medical and health care system, further improve the adverse drug reaction reporting and monitoring system, improve the capability of monitoring, evaluation and safety alert, and ensure drug safety for the public, the State Food and Drug Administration (SFDA) recently issued the Guiding Opinions on Enhancing the Construction of Adverse Drug Reaction Monitoring System in accordance with the Provisions for Adverse Drug Reaction Reporting and Monitoring. The Guiding Opinions defines the guidelines, basic principles, general objectives, responsibilities, construction requirements, key emphasis and guarantee measures for enhancing the construction of adverse drug reaction monitoring system.