Abstract

Regulatory science plays a critical role in balancing innovation, patient safety, and timely access to medicines. Despite its importance, little is known about how global research in this field has evolved. This study conducted a comprehensive bibliometric analysis of 20,371 publications indexed between 2005 and April 2025 across PubMed, Scopus, Web of Science, and ScienceDirect. Using Biblometrix in R, VOSviewer, and SciVal, the study explored publication trends, thematic evolution, collaboration networks, and citation impact. The results demonstrate consistent growth in regulatory science research over the past two decades. Core themes such as pharmacovigilance, drug safety, and clinical trials remain central, while newer areas including biosimilars, real-world evidence, and advanced therapies have gained prominence in response to technological advances and changing healthcare needs. Leading contributions originate from institutions such as INSERM, the FDA, and Harvard University, and countries including the United States, United Kingdom, and France. However, low- and middle-income countries remain underrepresented, despite their increasing importance in clinical trials and pharmaceutical supply chains. The findings highlight both progress and gaps in the field, emphasizing the need for greater inclusivity, regulatory harmonization, and capacity-building to strengthen global regulatory systems.

Key words: Regulatory science, Pharmacovigilance, Bibliometric analysis, Drug approval, Field-Weighted Citation Impact.