Calyx RIM Release Notes

Data Administration Tables Added: Calyx RIM 7.0

The following Data Administration tables, sections, or fields were modified with Calyx RIM 7.0.

Data Administration Section: Submission Maintenance

Data Administration Table Name Entity Affected Field Name Value List Description
Submission Maintenance > Drug Registration File Documents Section
  • EAEU Leaf
  • Drug Registration File Documents Section
  • Section Code
  • Section Name
To maintain the drug registration file documents section of the EAEU region, the Drug Registration File Documents Section Values table is introduced. The values for Section Code and Section Name can be entered in their respective fields.
Submission Maintenance > Drug Registration File Document Values
  • EAEU Leaf
  • Drug Registration File Document Values
  • Section
  • Document Code
  • Name
To maintain the drug registration file documents of the EAEU region, the Drug Registration File Document Values table is introduced. The values for Section, Document Code and Name can be entered or selected in their respective fields.
Submission Maintenance > Submission Product Type Values
  • CN 1.0 Folder
  • Submission Product Type Values
  • Region
  • eCTD Code
  • Product Type
  • Applicable DTD/Schema
The Submission Product Type Values table is added to maintain the submission product types of the China region. The values for Region, eCTD Code, Product Type, and Applicable DTD/Schema can be entered or selected in their respective fields.