This thesis investigates the evolution of drug regulatory guidelines within the context of globalization, analyzing how international forces have transformed pharmaceutical regulation from predominantly national systems to interconnected frameworks characterized by harmonization initiatives and collaborative governance. Through mixed-methods analysis of regulatory approval data from FDA, EMA, and PMDA spanning 1995-2024, combined with qualitative assessment of harmonization frameworks, this research examines regulatory convergence, guideline implementation patterns, and implications for pharmaceutical innovation and global health equity.