eCTD has been around for nearly 20 years and we’ve seen how it has transformed the regulatory submission landscape. The next major evolution in electronic submissions will be the transition from eCTD version 3.2.2 to eCTD version 4.0. To most people, it is viewed as very substantial and is leading to  many thought-provoking discussions:

The shift to eCTD v4.0 will bring many important changes. Changes such as having a single XML message instead of one regional and one ICH, a hierarchy that is more reflective of the submission business process, and life-cycle management that is far more sophisticated than what can be accomplished today. The most radical change is the eCTD v4.0 ability to be a bi-directional messaging platform between submitters and health authorities. It’s important to begin the education process within your organization around this entirely new approach to eCTD.