Data Migration Documentation

Calyx RIM 6.2 CHF 7 Data Migration

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 TW-1-0 implementation:

  • Associates Taiwan with Taiwan region in the Application Maintenance - Region Values, if it is not associated already.
  • Health Authority name for Taiwan country, that already exists in the Application Maintenance - Country Values in Data Administration under the Health Authority tab, must be changed to Taiwan Food and Drug Administration.
  • Adds the TW-1-0 assembly DTD type in the Assembly - Assembly DTD/Schema Types section in Data Administration, if it does not already exist.
  • 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 TW-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 TW-1-0 DTD/Schema. If the found Filing Type does not have Taiwan as an associated county, Taiwan 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 TW-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 Taiwan.
      Filing Type (Display) Applicable DTD/Schema eCTD Code Available for Application Type
      New TW-1-0 new NDA, CTA
      Change TW-1-0 change NDA, CTA
      Extension Filing TW-1-0 extension NDA, CTA
      Expiration TW-1-0 expiration NDA, CTA
Changes related to US-3-3 implementation:
  • If Form FDA 3988: Transmittal of PMR/PMC Submissions for Drugs and Biologics already exists in Application Form Type Values, it will be updated with fdaft10 code and set to Active. Otherwise, this record will be created.
  • If Form FDA 3938: Drug Master File already exist in Application Form Type Values already exists in Application Form Type Values, it will be updated with fdaft11 code and set to Active. Otherwise, this record will be created.
  • If REMS Supplement already exists in the Filing Type Values, it will be updated with fdaft11 Filing Type eCTD code for us-3-3 DTD, and New Drug Application, Biologic License Application, Abbreviated New Drug Application will be added to Types Valid for Grouped Submissions. Otherwise, this record will be created.
  • For the United States in the Country Values, the Health Authority Website will be updated to https://www.fda.gov/.