Calyx RIM 6.2.8 Data Migration

Run migration script to include latest 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. It must be added, if not present:

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

• Adds the CN-1-0 assembly DTD type in the Assembly - Assembly DTD/Schema Types section in Data Administration, if it does not already exist.
• New Procedure Type value to be added to Application Maintenance > Procedure Type Values, if it does not already exist, with attributes as below:

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

• Application Types will have no changes.
• The Filing Type values will be added to the Sequence Maintenance > Filing Type Values section in Data Administration, if they do not already exist. If they already exist, they will be updated with an eCTD Code for the CN-1-0 DTD/Schema based on the following approach:
  • For all the eCTD Codes from the table below, the Filing Type value that has the same eCTD Code 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, China will be added to the list of Countries.
  • If there are any other Filing Type values found, that are not listed in the table, they are not updated.
  • 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 for 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, one 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

  Note: The list of actual Application Types may differ from database to database. This is caused by user changes. During the migration, application types are added to fulfill the NMPA requirements, but are not removed to avoid user data corruption.