Calyx RIM 7.0 Publishing

Update eCTD XML Definition File Selections

When XML definition settings are updated, Calyx RIM prompts you to verify that you want to make the change. If you agree to the change, Calyx RIM automatically changes the folder and leaf types throughout the assembly to the proper versions.

In some cases, metadata is removed if it is no longer needed by the new specification XML definition. In most cases, Calyx RIM only adds new attributes or changes the labels or selections of existing attributes. If new sections are required by the new XML definition specification, it may be recommended to add these attributes separately using the Create eCTD wizard.

In every case it is a best practice to run the Create eCTD wizard immediately after updating the XML specifications.

For EU specifications, keep in mind the following:
  • When you include the electronic application form in EU module 1, section 1.2, ensure the form-1-1 rules are active in the publication settings to ensure the DTD and stylesheet are copied to the appropriate location during publishing.
  • If you are using v1.1 of the EU specifications, and submitting PIM information in section 1.3.1, you also need to ensure the pim-2-1 rules are active to ensure the supportive files are correctly output.
  • When you are using the v1.2.1 specification or later, these rules should not be active since the PIM information is provided as a single .zip file.