Data Administration Updates for Ennov InSight 7.1.3

Running the migration script results in multiple changes to the Data Administration data. The changes must be reviewed, and updated, if necessary.

Changes related to CN-1-0 implementation:

• Associates China with China region in the Application Maintenance - Region Values, if it is not associated already.
• Health Authority name for China country, that already exists in the Application Maintenance - Country Values in Data Administration under the Health Authority tab, must be changed to:

  Country Name	Health Authority Name	Health Authority Abbreviation	Health Authority Website
  China	National Medical Products Administration	NMPA	https://www.nmpa.gov.cn/

• The country value China will be updated to the China region if it does not belong to it already.
• The eCTD code cn will be assigned to the country value China..
• If the CN-1-0 Assembly DTD/Schema type already exists in the inactive state under Assembly > Assembly DTD/Schema Types section in Data Administration, it will be activated and updated to have the code value CN-1-0. Else, the CN-1-0 Assembly DTD/Schema will be added.
• New Procedure Type value will be added to Application Maintenance > Procedure Type Values the attributes below, if it does not exist already:

  Field Name	Field Value
  Procedure Type Abbreviation	CN - National
  Procedure Type Name	CN - National
  Display Name	National
  Countries	China
  Internal Procedure Code	NATIONAL
  eCTD Code	national
  Procedure Type Code	5
  Active Flag	Active

• No changes for Application Types.
• The filing type values will be added to the Sequence Maintenance > Filing Type Values section in Data Administration if they do not exist already. If they exist, they will be updated with an eCTD Code for CN-1-0 DTD/Schema based on the following approach:
  • For all eCTD Codes from the following table, the Filing Type Value that has the same name will be found and updated with the new eCTD Code for the CN-1-0 DTD/Schema. If the found Filing Type does not have China as an associated county, the value of China will be added to the list of Countries.
  • If more than one Filing Type is found with a matching eCTD Code, the one with the matching Filing Type Name will be updated with the new eCTD Code for the CN-1-0 DTD/Schema. If the Filing Type name does not match any Filing Type with a matching eCTD Code, no Filing Type will be updated and the following message will be added to the log: The Filing Type <name> with eCTD Code <code> could not be created/updated within Data Admin, please verify the configuration post-installation.
  • If the Filing Type is not found based on the eCTD Code, a new Filing Type will be created and assigned to China. The list of Filing Types:

    Filing Type (Display)	Applicable DTD/Schema	eCTD Code	Available for Application Type
    Original Application	CN-1-0	cnrat1	IND, NDA, ANDA
    Supplement Filing	CN-1-0	cnrat2	IND, NDA, ANDA
    Record	CN-1-0	cnrat3	IND, NDA, ANDA
    Annual Report Filing	CN-1-0	cnrat4	IND, NDA, ANDA
    New Indication and Drug Combination	CN-1-0	cnrat5	IND
    New Indication	CN-1-0	cnrat6	IND, NDA, ANDA
    Development Safety Report	CN-1-0	cnrat7	IND, NDA, ANDA
    Renewal Filing	CN-1-0	cnrat8	NDA, ANDA
    Baseline	CN-1-0	cnrat9	IND, NDA, ANDA