Ennov InSight 7.1 Data Migration Documentation

Post-Migration Script Updates for Ennov InSight 7.1.3

Changes affected by the migration script.

Migration affects the following changes:
  • Updates CN code value to the CN region in the database.
  • Updates the China eCTD Code to 'cn'.
  • Updates Health Authority Abbreviation to NMPA and Health Authority Website to https://www.nmpa.gov.cn/ in Application Maintenance > Country Values
  • Adds CN-1-0 assembly DTD type to Assembly > Assembly DTD/Schema Types in Data Administration, if it does not exist already.
  • Does not do any updates to Application Maintenance > Application Type Values .
  • Adds the following values to Sequence Maintenance > Filing Type Values in Data Administration if they do not exist already:
    • New Indication and Drug Combination
    • Record
    • Development Safety Report
  • Updates the following Filing Type eCTD Codes to Filing Type Values:
    • New Indication - cnrat6
    • Renewal Filing - cnrat8
    • Baseline - cnrat9
    • New Indication and Drug Combination - cnrat5
    • Record - cnrat3
    • Development Safety Report - cnrat7
  • Deactivates the following Filing Type eCTD Codes from Filing Type Values:
    • Periodic Safety Update Report - cnrat5
  • Assigns the New Indication and Drug Combination, Development Safety Report Filing Type values to the Original, Response, Withdrawal Sub Filing Type eCTD Сode values.
  • Unassigns the Periodic Safety Update Report Filing Type value from the Original, Response, Withdrawal Sub Filing Type eCTD code values.
  • Assigns the Application Type values to the Filing Type eCTD Code values:
    • Abbreviated New Drug Application to cnrat3
    • New Drug Application, Abbreviated New Drug Application to cnrat4
    • New Drug Application, Abbreviated New Drug Application to cnrat8
    • Investigational New Drug, New Drug Application, Abbreviated New Drug Application to cnrat9.