A comparative analysis of the evolution of drug regulatory science policies in China and the United States based on text visualization

JIAO Zu-fang; LI Jun; LAN Ya-fei; MAO Ning-ying

doi:10.20251/j.cnki.1003-3734.2025.13.003

Abstract：This paper conducts a visual analysis of the regulatory scientific policies of drug supervision between China and the United States,comparing the policy evolution process and the change in their focal points between China and the United States.The aim is to provide reference for the development of drug regulatory science policy in China.The policy documents related to drug regulatory science between China and the United States from the establishment of the database to 2023 were searched in the databases such as U.S.Food and Drug Administration and National Medical Products Administration.Gooseeker,AntConc and Excel were used to conduct text visualization research on the annual volume and keyword frequency of policy documents between China and the United States.The findings indicate that while there has been a rapid increase in the quantity of China's pharmaceutical regulatory science policies,some issues persist,such as the lack of official definition,the imperfect top-level policy design,the macro policy content in the frontier field,the late start of internationalization and the decline of attention to traditional Chinese medicine.To promote the scientific development of China's drug regulatory science policies,it is essential for China to clarify the official definition of drug regulatory science.Additionally,more policies focusing on the top-level design should be issued;greater emphasis should be placed on more cutting-edge and comprehensive key areas;new paradigms should be constructed for the development of Chinese medicine regulatory science policy;and efforts towards accelerating the internationalization of China's drug regulatory science policies should be intensified.