Excel and Cite Space were used to perform bibliometrics and knowledge map study of relevant literature from 1983 to 2021 in the field of drug regulatory science of CNKI in China. Research status and development trends are analyzed from the annual amount of articles, literature sources, foundation, research hotspots and research subjects. The study finds that by 2021, drug regulatory science research in China has reached a certain scale, with the number of articles increased rapidly. The number of publications in core journals have began to increase, and 33.89% of the articles were supported by the fund. Research hotspots focused on two aspects: pharmacovigilance with its related systems, and new methods and technologies of drug regulation. A network of collaboration has been formed among major researchers and research institutions, with close cooperation among universities, medical institutions, and government agencies. However, a certain geographical restriction existed in the cooperation. To promote the healthy and rapid development of drug regulatory science research in China, it is necessary to improve the quality of published research results, deeply dig the frontier research directions, and encourage international-domestic exchanges and collaboration. At the same time, it is also important to break the regional cooperation barriers in current research network, mobilize the enthusiasm of medical enterprises, and widen the cooperation among medical enterprises, universities, medical institutions, and government agencies.