OBJECTIVE: To investigate the status quo and characteristics of manufacturing and selling counterfeit drugs in China, and to explore supervision strategies. METHODS: Among 7 500 counterfeit drugs cases investigated by public security organization during 2011-2015, 50 typical cases, which involved large amount of counterfeit drugs, large sum of money, a large number of people, a broad geographic area and huge social consequences, were selected and analyzed to put forward supervision strategies. RESULTS & CONCLUSIONS: Both the case number of counterfeit drug and the people involved were increasing rapidly in China, increasing from 500 cases and 900 persons in 2011 to 2 500 cases and 6 000 persons in 2015. Among 50 typical cases, involved counterfeit drugs mostly focused on sexual dysfunction drugs (23.8%), cosmetic drugs and weight loss drugs (19.6%), antitussive and antiasthmatic drugs (14.2%), anti-rheumatism drugs (13.9%), antidiabetic drugs (7.3%) and antitumor drugs (6.6%), etc. There were 42 cases of online counterfeit drugs sales (84%), 46 cases of counterfeit drugs production and sales activities without a license (92%) and 3 cases of illegal counterfeit drugs purchase service (6%). On the whole, manufacturing and selling counterfeit drugs activity in China has the following features, such as large sum of money is involved; criminal activities are very covert; most victims are low-income workers. It is suggested to strengthen the supervision work and innovative approach; enhance the joint law enforcement of drug administration and public security organs,and promote connection between administrative law enforcement and criminal justice of drug cases; innovate information operation system and mechanism, and establish information sharing platform and reporting system; strengthen the monitoring of internet and cooperation with pharmaceutical companies; improve the publicity and deter criminals.