As eCTD 4.0 Adoption Inches Forward, A New ICH Guideline Puts It To The Test

By Karl-Heinz Loebel

Regulatory submissions are entering a period of meaningful structural change. eCTD 4.0 is gaining traction at both the FDA and EMA, offering practical improvements over its predecessor: more flexible document re-use across applications, universally unique identifiers for cleaner cross-referencing, and an adaptable submission structure that can accommodate evolving regulatory requirements.

The forthcoming M4Q (R2) guideline stands to accelerate this shift by restructuring the CTD's quality modules, moving narrative content into Module 2 and repositioning Module 3 as a technical data repository. For regulatory teams managing complex product lifecycles, understanding how these two standards interact will be essential preparation for what lies ahead.