Calyx RIM 6.2 CHF 4 Data Migration
Running the migration script results in multiple changes to the Data Administration data. The changes must be reviewed, and updated if necessary.
China
Changes related to China implementation:
- Associates China country with China region in the Application Maintenance - Region Values.
- 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.
- Sets the value for eCTD Code for the China country in the Application Maintenance – Country Values section of Data Administration.
- Creates the CN - National procedure type value in the Application Maintenance - Procedure Type Values.
- Removes any existing associations to application procedure types for each of the China country and associates it to the ‘CN - National’ procedure type in the Application Maintenance - Procedure Type Values.
- Removes any existing associations to application types for China country and associates China to the IND, NDA, and ANDA application types in the type in the Application Maintenance - Application Type Values.
- Updates Health Authority attributes for China country in the Application Maintenance – Country Values.
- Adds the following values to the
Sequence Maintenance – Filing type Values in
Data Administration if they do not exist already:
- 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 Values
section in
Data Administration if they do not exist already:
- Original
- Response
- Withdrawal
- Reformat
EAEU
Changes related to EAEU implementation:
- 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 the EAEU region in Application Maintenance – Country Values.
- Adds the ‘EAEU-1-0’ assembly DTD type in the Assembly - Assembly DTD/Schema Types section in Data Administration, if it does not already exist.
- Sets the value for ‘eCTD Code’ for the Armenia, Belarus, Kazakhstan, Kyrgyzstan, and Russian Federation countries in the Application Maintenance – Country Values section of Data Administration.
- Creates the ‘EAEU MRP’ , 'EAEU DCP', 'EAEU National' procedure type values in Application Maintenance - Procedure Type Values.
- Adds all the values to Drug Registration File Documents Section Values.
- Adds all the values to Drug Registration File Documents Values.
Entities: Product Family
- A new field, Show in Tree, with Yes/No options has been added to the Product Family entity, applicable for all Product Family Types.
- All entities migrated from previous application versions will migrate with Yes selected and will be shown in the Product Family Tree.