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Tag: narrow therapeutic index

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

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

  • 29.11.2025
  • Elliot Kelly
  • 1 Comments

NTI generics require tighter regulatory controls due to their narrow safety margin. This article compares how the FDA, EMA, Canada, Japan, and others regulate these high-risk drugs - and what it means for patient safety and global access.

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