Module 1 eCTD 4.0 Regional Templates

Each regional eCTD 4.0 template has сontrolled vocabulary attributes in the Module 1 folder to conform to regional regulatory guidelines and requirements.

Module 1 of the eCTD 4.0 contains regional content and metadata about a submission, as defined by the regional regulatory authorities.

When an assembly is created using the Create eCTD Wizard, the wizard filters the template to only display structure for the countries already associated with that sequence.

Ennov InSight Publisher 7.3: eCTD 4.0

Assembly Templates and Controlled Vocabulary Dependencies