Abstract

A COMPARATIVE REVIEW OF DRUG REGISTRATION AND REGULATORY REQUIREMENTS IN NORTH AMERICA AND EUROPE

Leemol Varghese*, Sithwath Shah Moiza

Abstract

Regulatory harmonization has improved consistency in pharmaceutical development and global submissions; however, important differences remain between the regulatory systems of the United States and European Union, influencing development strategies, submission requirements, approval pathways, and post-approval management. This study aimed to comparatively evaluate regulatory requirements and strategic considerations for medicinal product registration in the United States and European Union, with emphasis on marketing authorization, expedited pathways, pediatric development, orphan-drug requirements, risk management, post-approval changes, and pharmacovigilance. A qualitative documentary comparison was performed using regulatory guidelines, assessment reports, approval documents, and scientific literature. Lemborexant, Truxima (rituximab), and Luxturna (voretigeneneparvovec) represented small-molecule, biosimilar, and gene-therapy products, respectively. The Common Technical Document and electronic Common Technical Document have facilitated preparation of a common scientific dossier and reduced regulatory duplication; however, significant regional differences remain in administrative procedures, pediatric requirements, risk management, evidentiary expectations, post-approval changes, and pharmacovigilance. Successful global registration therefore requires a harmonized scientific strategy combined with appropriate regional adaptation. Early regulatory interaction, coordinated pediatric planning, product-specific regulatory strategies, and proactive lifecycle management may improve submission readiness, minimize regulatory duplication, and support efficient medicinal product development and registration across both regions.

Keywords: Drug Registration; Regulatory Harmonization; Pharmaceutical Regulation; Marketing Authorization; Pharmacovigilance; Lifecycle Management.