Data Migration Documentation

Post-Migration Script Updates for Calyx RIM 6.2 CHF 4

The migration script will perform multiple changes to the Data Administration. These should be verified, and where necessary, updated.

Following are the set of changes for China and EAEU:

  • Associates China country with China region in the Application Maintenance - Region Values.
  • CN-1-0 Assembly DTD /Schema type will be added to the Assembly > Assembly DTD/Schema Types section in Data Administration section, if it does not already exist.
  • The Application Maintenance > Country Values section of Data Administration will be updated to set the value for the eCTD Code for the China country.
  • A procedure type value CN-National will be created in the Application Maintenance - Procedure Type Values section.
  • Existing associations to application procedure type will be deleted for China country and will be associated to CN-National procedure type.
  • Existing associations to application types for China country will be deleted and will be associated to the IND, NDA, and ANDA application types.
  • Updates Health Authority attributes for China country region in the Application Maintenance – Country Values.
  • Filing Type Values will be added to the Sequence Maintenance > Filing Type Values section in Data Administration, if they do not already exist.
    • Original Application
    • Supplement Filing
    • New Indication
    • Annual Report Filing
    • Periodic Safety Update Report
    • Renewal Filing
    • Baseline
  • Adds the following values to the Submission Maintenance – Submission Product Type Values section in Data Administration if they do not exist already:
    • Chemical Product
    • Biological Product
  • Adds the following values to the Submission Maintenance - Sub Filing Type section in Data Administration if they do not already exist:
    • Original
    • Response
    • Withdrawal
    • Reformat
  • Updates Health Authority attributes for Armenia, Belarus, Kazakhstan, Kyrgyzstan, and Russian Federation countries in the Application Maintenance > Region Values.
  • Associates Armenia, Belarus, Kazakhstan, Kyrgyzstan, and Russian Federation countries with EAEU region in Application Maintenance > Country Values.
  • EAEU-1-0 Assembly DTD /Schema type will be added to the Assembly > Assembly DTD/Schema Types section in the Data Administration section, if it does not already exist.
  • The Application Maintenance > Country Values section of Data Administration will be updated to set the value for the eCTD Code for the Armenia, Belarus, Kazakhstan, Kyrgyzstan, and Russian Federation countries.
  • A procedure type value EAEU MRP will be created in the Application Maintenance > Procedure Type Values section.
  • Existing associations to application procedure type will be deleted for EAEU and will be associated to the EAEU – MRP, EAEU – DCP, EAEU – National procedure type.
  • Adds all the values to Drug Registration File Documents Section Values.
  • Adds all the values to Drug Registration File Documents Values.