TGA-2023-0007
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-007
Application Number
TGA-2023-0007
Procedure Type
Label Update
Status
Submitted
Linked Product
Market Authorization
Australia · TGA
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-007 | eCTD | 7.6.1 | 5 | M1 (12), M2 (11), M3 (4), M4 (7), M5 (5) | Draft |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| GMP inspection findings clarification | 2024-12-06 | high | Overdue |
| Request for benefit-risk assessment addendum | 2025-03-31 | high | Draft |
| Request for additional clinical data on primary endpoint | 2025-04-19 | medium | Overdue |
| Request for updated SmPC section 4.1 | 2024-12-13 | medium | Draft |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Provide 36-month accelerated stability data for 25°C/60% RH condition | 2025-12-18 | medium | In Progress |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-019 | PIL | 16.4 | Active |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| TGA-2023-0007-V007 | Minor | Completed | 2023-04-24 |
| TGA-2023-0007-V107 | Major | In Progress | pending |
| TGA-2023-0007-V207 | Minor | Failed | 2022-07-30 |
| TGA-2023-0007-V307 | Type IA | Completed | 2024-02-23 |
| TGA-2023-0007-V407 | Minor | Overdue | 2024-02-18 |
Inspection Readiness Risk Panel
Risk Score: 6 · Overdue commitments: 0, failed/blocked sequences: 2, high-risk questions: 2.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.