Objective: To solve the problems of information disclosure, update and application of drug labels by constructing a co-governance system in China. Methods: Through searching the keywords “drug label” on Wanfang data knowledge service platform, China National Knowledge Infrastructure, European Medicines Agency website and U.S. Food and Drug Administration website, the relevant situation of information disclosure, update and application of drug labels at home and abroad was sorted out. Through field research, interviews, seminars and other means, the study understood the use requirements, disclosure willingness and information application needs of drug labels of all relevant parties, so as to put forward work suggestions and information conceptions. Results and Conclusion: Because the reform of the drug evaluation and approval system was deepening and relevant laws and regulations on the disclosure and update of drug labels were improving these years, the drug labels were constantly standardized in China. However, there were still some problems such as the inadequate implementation of the marketing authorization holder’s (MAH’s) subject responsibility, non-standard and non-sharing of information, and poor application of information technology. Building a co-governance system of drug labels can provide ideas for solving related problems, and the drug regulatory departments could guide MAH implementing their subject responsibility. MAH could implement their subject responsibility of timely information disclosure and update of drug labels. All parties jointly help to enhance the level of rational and safe use of drugs in China.
Key words
drug label； co-governance； information disclosure； information update； information application
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