SFDA-2023-0037
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-037
Application Number
SFDA-2023-0037
Procedure Type
Lifecycle Extension
Status
Completed
Linked Product
Market Authorization
Australia · SFDA
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-037 | NeeS | 5.2.8 | 5 | M1 (12), M2 (12), M3 (10), M4 (11), M5 (8) | Overdue |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Deficiency letter: missing stability data for 40°C condition | 2025-03-21 | medium | Open |
| Information request: manufacturing process change justification | 2024-12-01 | medium | Overdue |
| Query: container closure integrity study methodology | 2025-04-19 | high | Overdue |
| Request for updated SmPC section 4.1 | 2025-03-12 | low | Overdue |
| Deficiency letter: missing stability data for 40°C condition | 2025-01-12 | medium | Open |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Provide carcinogenicity study report for 2-year rat study | 2025-01-18 | high | Blocked |
| Submit final study report for paediatric use study KCL-PED-001 | 2025-09-04 | high | Open |
| Provide 36-month accelerated stability data for 25°C/60% RH condition | 2024-11-12 | high | In Progress |
| Provide 36-month accelerated stability data for 25°C/60% RH condition | 2025-09-21 | medium | Open |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-109 | SmPC | 1.2 | Pending |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| SFDA-2023-0037-V037 | Major | Failed | 2023-08-18 |
| SFDA-2023-0037-V137 | Major | Draft | 2023-08-13 |
| SFDA-2023-0037-V237 | Type IA | Submitted | pending |
| SFDA-2023-0037-V337 | Major | Active | 2023-07-09 |
| SFDA-2023-0037-V437 | Type IB | Pending | 2023-07-11 |
Inspection Readiness Risk Panel
Risk Score: 5 · Overdue commitments: 0, failed/blocked sequences: 2, high-risk questions: 1.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.