TGA-2023-0067
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-067
Application Number
TGA-2023-0067
Procedure Type
NDA
Status
Active
Linked Product
Market Authorization
Australia · TGA
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-067 | NeeS | 3.3.1 | 5 | M1 (7), M2 (6), M3 (9), M4 (13), M5 (3) | In Progress |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Request for additional clinical data on primary endpoint | 2025-01-23 | medium | Draft |
| Request for updated SmPC section 4.1 | 2025-01-22 | high | Overdue |
| Query regarding bioequivalence study design | 2024-11-25 | medium | Open |
| Query: container closure integrity study methodology | 2025-03-18 | low | Overdue |
| Query regarding bioequivalence study design | 2025-03-12 | medium | Draft |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Update SmPC section 4.4 with hepatic impairment data | 2025-06-28 | high | In Progress |
| Submit annual PSUR covering the period Jan 2024 – Dec 2024 | 2025-09-12 | medium | In Progress |
| Provide confirmatory bioequivalence study for 200 mg strength | 2025-07-26 | high | In Progress |
| Submit final study report for paediatric use study KCL-PED-001 | 2025-09-28 | medium | Overdue |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-199 | SmPC | 6.8 | In Progress |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| TGA-2023-0067-V067 | Type IB | Failed | 2024-06-02 |
| TGA-2023-0067-V167 | Type IA | Blocked | 2022-09-10 |
| TGA-2023-0067-V267 | Major | Active | 2023-07-03 |
| TGA-2023-0067-V367 | Type II | Completed | 2023-05-03 |
| TGA-2023-0067-V467 | Minor | Failed | pending |
Inspection Readiness Risk Panel
Risk Score: 3 · Overdue commitments: 1, failed/blocked sequences: 0, high-risk questions: 1.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.