TGA-2023-0047
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-047
Application Number
TGA-2023-0047
Procedure Type
NDA
Status
Completed
Linked Product
Market Authorization
Singapore · TGA
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-047 | eCTD | 4.2.7 | 5 | M1 (4), M2 (5), M3 (3), M4 (6), M5 (15) | Failed |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Request for additional clinical data on primary endpoint | 2025-04-08 | low | In Progress |
| Deficiency: inadequate paediatric data justification | 2025-02-21 | medium | In Progress |
| Information request: manufacturing process change justification | 2024-12-19 | medium | Open |
| Request for post-marketing commitment progress update | 2025-01-06 | medium | Draft |
| Information request: manufacturing process change justification | 2025-02-03 | low | In Progress |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Update SmPC section 4.4 with hepatic impairment data | 2025-11-15 | low | Overdue |
| Provide carcinogenicity study report for 2-year rat study | 2025-09-19 | high | Overdue |
| Provide 36-month accelerated stability data for 25°C/60% RH condition | 2025-06-02 | low | In Progress |
| Submit harmonised global label per ICH Q12 PLCR | 2025-10-08 | medium | Overdue |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-139 | Labeling | 19.8 | Active |
| LBL-140 | Labeling | 9.2 | Submitted |
| LBL-141 | SmPC | 5.9 | Active |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| TGA-2023-0047-V047 | Minor | Submitted | pending |
| TGA-2023-0047-V147 | Type II | Pending | 2023-09-11 |
| TGA-2023-0047-V247 | Minor | In Progress | 2022-09-03 |
| TGA-2023-0047-V347 | Type IA | Active | 2023-02-12 |
| TGA-2023-0047-V447 | Type IB | Submitted | pending |
Inspection Readiness Risk Panel
Risk Score: 6 · Overdue commitments: 3, failed/blocked sequences: 0, high-risk questions: 0.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.