Same Structure, Different Story
How one set of clinical data becomes three different regulatory narratives
The key insight: Modules 3, 4 and 5 flow relatively unchanged to all regulators — the science is the same. But Module 1 is completely different for each jurisdiction, and Module 2 requires different narrative emphasis. The structure is standardised. The story isn't.
Source: eCTD framework. 8 million+ submissions through FDA since 2003. 94% adoption by 2022 (eCTD Pharma, 2025)