Differences in Filing Types and eCTD codes of China drafts 2019 and 2021.
Differences in China Filing Types and Sub Filing Types and their eCTD codes between the draft of 2019 and the final draft of 2021.
Filing Type and eCTD code
Verify you have the correct data after the migration is completed.
| Draft 2019 Filing Type | Draft 2019 eCTD Code | Final 2021 Filing Type | Final 2021 eCTD Code |
|---|---|---|---|
| Original Application | cnrat1 | Original Application | cnrat1 |
| Supplement Filing | cnrat2 | Supplement Filing | cnrat2 |
| New Indication | cnrat3 | New Indication | cnrat6 |
| Annual Report Filing | cnrat4 | Annual Report Filing | cnrat4 |
| Periodic Safety Update Report | cnrat5 | CN eCTD code is deactivated | |
| Renewal Filing | cnrat6 | Renewal Filing | cnrat8 |
| Baseline | cnrat7 | Baseline | cnrat9 |
| New Indication and Drug Combination | cnrat5 | ||
| Record | cnrat3 | ||
| Development Safety Report | cnrat7 |
Sub Filing Types eCTD Codes
| Sub Filing Type | Draft 2019 Filing Types | Final 2021 Filing Types | Difference |
|---|---|---|---|
| Original | Original Application, Supplement Filing, New Indication, Annual Report Filing, Periodic Safety Update Report, Renewal Filing. | Original Application, Supplement Filing, New Indication and Drug Combination, Development Safety Report, Record, Annual Report Filing, New Indication, Renewal Filing. | Added: New Indication and Drug Combination, Development Safety Report.
Removed: Periodic Safety Update Report. |
| Response | Original Application, Supplement Filing, New Indication, Annual Report Filing, Periodic Safety Update Report, Renewal Filing, Baseline. | Original Application, Supplement Filing, New Indication and Drug Combination, Development Safety Report, Record, Annual Report Filing, New Indication, Renewal Filing, Baseline. | Added: New Indication and Drug Combination, Development Safety Report.
Removed: Periodic Safety Update Report. |
| Withdrawal | Original Application, Supplement Filing, New Indication, Annual Report Filing, Periodic Safety Update Report, Renewal Filing, Baseline | Original Application, Supplement Filing, New Indication and Drug Combination, Development Safety Report, Record, Annual Report Filing, New Indication, Renewal Filing, Baseline | Added: New Indication and Drug Combination, Development Safety Report.
Removed: Periodic Safety Update Report. |
| Reformat | Baseline | Baseline | No changes. |