Requirements for Successful eCTD Imports

To ensure successful importing of eCTD assemblies, confirm that specific conditions are met in your system.
  • In Data Administration > Other > Assembly Subcategories Values, do not disable the subcategory values for eCTD Submissions.
  • When importing US-3-3 eCTDs, the Application Code in the XML must match the Application Code in LIQUENT InSight.
  • The index, regional, and content files must follow the naming convention filename.extension. This is not an issue on file systems. However, it is critical in a DMS where the file name may not have the extension appended, but rather, is identified as a format type. As an example, a file named index with a format type of xml will not import, but index.xml will import. The same is true for content files. For example, cover-letter.pdf will import but cover-letter with a format type of pdf will not.
  • For a bulk eCTD import, the Product Family and Application entities must exist in Calyx RIM.