SFDA-2023-0057
This application view consolidates identifiers, linked product and market authorization context, dossier structure, sequence history, and active authority obligations in one place. Regulatory teams use it to understand readiness and risk before publishing new sequences or responding to open questions. Cross-links to labeling and variations maintain lifecycle traceability for post-approval changes. Inspection readiness risk is calculated from overdue commitments, failed sequences, and unresolved high-risk correspondence for immediate action.
Application ID
APP-057
Application Number
SFDA-2023-0057
Procedure Type
Lifecycle Extension
Status
In Progress
Linked Product
Market Authorization
Belgium · SFDA
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-057 | eCTD | 2.5.7 | 5 | M1 (8), M2 (15), M3 (12), M4 (8), M5 (10) | Overdue |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Deficiency letter: missing stability data for 40°C condition | 2025-04-01 | low | Overdue |
| Request for updated SmPC section 4.1 | 2024-12-27 | low | In Progress |
| Information request: extractables and leachables data | 2025-01-15 | medium | In Progress |
| Query regarding bioequivalence study design | 2025-04-04 | low | Overdue |
| Request for post-marketing commitment progress update | 2024-12-13 | medium | Open |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Provide carcinogenicity study report for 2-year rat study | 2025-04-09 | low | Blocked |
| Submit final study report for paediatric use study KCL-PED-001 | 2025-07-14 | medium | Overdue |
| Update SmPC section 4.4 with hepatic impairment data | 2024-11-16 | high | In Progress |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-169 | PIL | 11.1 | Approved |
| LBL-170 | SmPC | 2.8 | Pending |
| LBL-171 | SmPC | 10.1 | In Progress |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| SFDA-2023-0057-V057 | Type IB | Active | 2023-05-11 |
| SFDA-2023-0057-V157 | Type IA | Draft | 2023-01-25 |
| SFDA-2023-0057-V257 | Type IA | Active | 2023-01-27 |
| SFDA-2023-0057-V357 | Type II | Failed | 2023-02-12 |
| SFDA-2023-0057-V457 | Type II | Approved | pending |
Inspection Readiness Risk Panel
Risk Score: 4 · Overdue commitments: 1, failed/blocked sequences: 1, high-risk questions: 0.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.