eCTD v4 represents the natural evolution of regulatory submissions – like a species adapting to a changing environment. The core structure, shaped by the ICH framework in Modules 2–5, has undergone global harmonization and will be implemented the same across regions implementing v4. The real localisation occurs within Module 1, where we see regional adaptations taking place.
The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (US FDA) are taking their natural leadership roles within this evolution and spearheading the development that will shape the global landscape of submission management. These differences, while foundationally similar, in the way each regional nuances are expressed will impact the life science and global regulatory ecosystem. As eCTD v4 continues to grow, understanding these regional variations will be key to thriving in the global submission landscape.
The EMA and the US FDA have the shared objective of implementing eCTD v4 that will lay a strong foundation in the digital world; by leveraging structured data and opening possibilities for. In this blog, we will guide you through the regional differences.
EMA vs. US FDA: Key Differences in Module 1
Recent Module 1 Changes
While both agencies build on the same ICH foundation, their regional Module 1 requirements represent distinct adaptations to their regulatory environments. The EMA emphasizes a strict controlled vocabulary and is already testing forward compatibility for v4. The US FDA, while also enforcing coded lists, leaves room for flexibility with its free-text description and has already opened the door to v4 submissions (new applications only).
For regulatory teams, the message is clear:
By keeping pace with these evolving rules and preparing proactively, sponsors can thrive in the global submission landscape – whether adapting to the EMA’s tightly structured approach or the US FDA’s more flexible environment.