Regulatory approval trends and market access implications: a multiregional comparative framework for new and supplemental drug applications (2020–2025)

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BACKGROUND: Drug approval remains fragmented, governed by region-specific regulatory frameworks and review pathways. Despite international harmonization, the same product is often approved at different timelines and under different pathways across regions, complicating regulatory planning. Currently, there is no unified system that enables concurrent comparison of multiregional drug approvals. METHODS: Drug Approvals in the US, EU, Japan, and India were evaluated from Jan-2020 to June-2025. NDA approvals were assessed year-wise, review type, and by pharmacotherapeutic area to identify key focus areas. Supplemental approvals were analyzed year-wise, application categorywise, and by therapeutic area to understand post-approval patterns. This study analyses multiregional approval trends and addresses this gap through an integrated analytical framework. To enable integrated multiregional assessment, a web-based regulatory intelligence dashboard was developed. RESULTS: The dashboard consolidates approval data across regions and parameters into a harmonized interface for simultaneous visualization, comparison and assessment across multiple jurisdictions. For pharmaceutical manufacturers, the availability of such a platform enables monitoring of approval patterns, identifying unapproved or underexplored markets and supporting data-driven strategic planning for earlier market access. The dashboard provides regulatory authorities, sponsors, researchers and policy makers consolidated visibility into cross-regional activity. CONCLUSION: Overall, the dashboard enables data-driven comparison by addressing a gap in existing information systems.

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