Analysis of Regulatory Strategies for Generic Product Approval across Asian Nations

Abstract

The pharmaceutical industry is critical for providing accessible, affordable healthcare globally. This study compares regulatory strategies for generic drug approvals in Europe and Asia, focusing on India, China, and Japan. It analyzes legal frameworks, evaluation criteria, data requirements, and approval timelines, aiming to understand the impact on the efficiency of generic drug market entries in these regions. The research methodology includes reviewing regulatory guidelines, legislative documents, scholarly publications, and conducting interviews and surveys with industry experts. Preliminary findings reveal significant differences in the legal and procedural requirements across Asian nations, with variations in the emphasis on local clinical data and approval timelines. These disparities affect market accessibility, competition, and healthcare affordability. Insights from this study are vital for pharmaceutical companies navigating international markets and for policymakers aiming to harmonize and expedite approval processes, ultimately improving global access to cost-effective healthcare solutions.Top of Form