ABSTRACT

Drug repurposing is a promising strategy for developing new therapeutic options by leveraging existing compounds. However, regulatory pathways for repurposing vary across regions, posing challenges for global pharmaceutical manufacturers. This study compares the regulatory frameworks for repurposed drugs in the US and Japan, two key markets with distinct approaches. The FDA of US and PMDA of Japan establish guidelines, requirements, and approval processes, identifying similarities and differences. This research also investigates the implications of these regulatory disparities for Indian pharmaceutical manufacturers, who seek to capitalize on opportunities presented by drug repurposing to address unmet medical needs and enhance their competitive position in the international market. By assessing comparative regulatory analysis and industry perspectives, this study aims to provide valuable recommendations for Indian pharmaceutical manufacturers to navigate regulatory complexities effectively, streamline drug repurposing processes, and enhance their competitiveness in the global pharmaceutical landscape. Keywords: Drug repurposing, US FDA, PMDA, Regulatory frameworks, 505(b)(2)
Publication date: 01/07/2025

https://ijbpas.com/pdf/2025/July/MS_IJBPAS_2025_9249.pdf

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https://doi.org/10.31032/IJBPAS/2025/14.7.9249