Who specifies the organization of content for CTD/eCTD?
For Modules 2-5 (excluding the Regional Section within Module 3), the ICH specifies the organization and content for CTD/eCTD. For Regional Sections (Module 1 and the Regional Section within Module 3), the specific Regulatory Authority (i.e., FDA) specifies the organization and content for CTD/eCTD. Regional Section Content may vary between Regions (i.e., US/Japan).
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- Who specifies the organization of content for CTD/eCTD?
