ABSTRACT
OBJECTIVE:To provide reference for strengthening drug regulation in drug administration department. METH-ODS:Drug regulatory statistical yearbooks during 2011-2015 were collected. Literature analysis,content analysis,comparative analysis and secondary analysis were conducted to analyze and explore the drug production license,business license,advertising ap-proval,protection of TCM varieties,drug complaints,investigation and punishment of drug cases,etc. in statistical yearbook. RE-SULTS & CONCLUSIONS:The number of drug manufacturers and operating enterprises had been increasing year by year,while the retail chain stores in certified enterprises showed tendency to go beyond the single retail pharmacy. Compared with the down-ward trend of number of approved drug advertisements,the number of protected varieties of TCM decreased more obviously. The increase in number of drug complaints did not cause the number of investigated and punished drug cases at the same time,which showed a downward trend. It is suggested to further improve the quality and efficiency of drug regulatory work in China by strict drug production license approval,reforming drug advertising regulation and TCM varieties protection system,intensifying efforts to investigate and punish drug complaints and cases,and playing the supervision of public opinion role of the media and the masses.