eCTD Assemblies

Ennov InSight includes eCTD 4.0-compliant assembly templates. The eCTD 4.0 assembly templates include all sections that conform to the requlatory requirements eCTD assemblies include predefined Context of Use codes with metadata for specific headings.

You can create eCTD templates using one of the following ways:

— Create an assembly using a module 1 template, then import additional modules from the eCTD ICH Module 2-5 template.

— Create a new template based on a module 1 template, with the eCTD ICH Module 2-5 template imported. You can subsequently create new assemblies using this template.

— Create an assembly using the eCTD ICH Module 2-5 template, then import the module 1 folder from a module 1 template.

While you are allowed to include more than one set of CV Profiles, make sure to include only one regional and one ICH profile. For example, do not include two versions of an EU Module regional CV Profile. This may cause errors during publishing.