Module 1 Regional Templates

Module 1 of the eCTD contains regional content and metadata about a submission, as defined by the regional regulatory authorities. Each regional template has special XML fields and attributes in the Module 1 folder to capture this additional metadata.

In addition, the EU requires envelope information for each country to which you are sending the submission. For each envelope, you create a folder to capture the relevant envelope information for each country under the EU Envelope Information leaf. Envelope folders are included in the EU Module 1 templates.

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.