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  • November 14, 2025

International Perspectives on NTI Generics: How Regulatory Approaches Differ Across Countries

International Perspectives on NTI Generics: How Regulatory Approaches Differ Across Countries

NTI generics require strict regulatory oversight due to their narrow safety margin. This article compares how the FDA, EMA, Canada, Japan, and others regulate these high-risk drugs - and why global alignment is critical for patient safety.

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