To explore the research hotspots and development trends of global drug regulatory science, and to provide reference for promoting the sustainable development of drug regulatory science in China.

The literatures related to drug regulatory science published from 1991 to 2023 was searched from Web of Science database, and the contents of time distribution, author, institution, country / region and keywords were analyzed by CiteSpace 5.8.R3.

A total of 540 papers were included, and the annual number of published papers showed a stable growth trend. Foreign regulatory scientific research started early, and now it has formed a relatively complete regulatory scientific development system, and formed a relatively close cooperative relations among countries and institutions. Drug regulatory science research has evolved from an initial stage to a stage of refined research around new tools, standards, and methods; research hotspots include drug development, risk assessment, biomarkers, etc.

China’s drug regulatory authorities can increase policy guidance, strengthen basic theoretical research and applied capacity building, promote interdisciplinary joint research, and build a multidisciplinary academic exchange platform in order to accelerate the development of drug regulatory science.