규제과학 분야의 연구 동향에 대한 계량서지학적 분석

초록

To analyze the overall research trends in regulatory science, this study conducted a quantitative bibliometric analysis of publications from 1995 to October 2025. Bibliographic records related to regulatory science were retrieved from the Web of Science (WoS) database, and analyses of publication status, citation metrics, institutional contributions, and keyword co-occurrence networks were performed using R (version 4.5.0) and VOSviewer (version 1.6.20). A total of 1,104 articles were included in the study, showing a steady annual growth rate of 12.92%. The average number of co-authors per document was 6.72, and 27.99% of publications involved international collaboration, indicating a high level of global cooperation. The U.S. Food and Drug Administration (FDA) was identified as the most productive institution, followed by leading universities and pharmaceutical companies, forming a strong government–academia–industry network. A total of four clusters were identified in the keyword analysis: drug development, pharmacokinetics, tobacco regulatory science, and medical devices. Recent research also show a growing focus on artificial intelligence and digital technologies. Analysis of highly cited papers demonstrates that regulatory science enables evidence-based policy, risk management, and technology assessment across healthcare domains. These findings clarify the international landscape and collaboration networks in regulatory science, providing a foundation for future research, policy development, and capacity building.

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