Abstract: Objective To summarize the practices of the FDA in public drug risk communication, and provide reference for the improvement of drug risk communication in China. Methods Chinese and foreign literature was reviewed in order to summarize the influencing factors of public perceptions of drug risks based on the risk perception theory. The practices regarding drug risk communication adopted by the FDA and its counterpart in China were analyzed in terms of ways of communication, time of communication, contents of communication and channels of communication. Results There are some problems with drug risk communication in China, such as limited public participation, a lack of workable guidelines for risk communication, communication channels that fail to distinguish targeted audiences, and improper contents of communication. Conclusion It is suggested that China's regulatory authorities should learn from internationally accepted practices and formulate strategic plans or guidelines for risk communication, and optimize risk communication between drug regulatory agencies and the public by advancing public understanding of drug safety, promoting public participation, improving communication contents and diversifying communication channels.

Key words: drug risk information, risk communication, risk perception, FDA