TGA-2023-0027
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-027
Application Number
TGA-2023-0027
Procedure Type
NDA
Status
Blocked
Linked Product
Market Authorization
Belgium · TGA
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-027 | CTD | 8.0.6 | 5 | M1 (4), M2 (3), M3 (6), M4 (15), M5 (10) | Blocked |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Question on comparative dissolution data | 2024-12-22 | medium | Open |
| Deficiency letter: missing stability data for 40°C condition | 2024-12-14 | medium | In Progress |
| Request for post-marketing commitment progress update | 2025-01-01 | low | Open |
| Information request: extractables and leachables data | 2025-04-03 | medium | In Progress |
| Information request: extractables and leachables data | 2025-01-10 | low | Overdue |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Submit final study report for paediatric use study KCL-PED-001 | 2025-04-29 | low | Overdue |
| Implement Risk Minimisation Measures (RMM) per REMS requirements | 2025-11-04 | high | In Progress |
| Validate analytical method for dissolution test per USP <711> | 2024-12-13 | medium | Open |
Linked Labeling and Variations
| Variation | Type | Status | Submitted |
|---|---|---|---|
| TGA-2023-0027-V027 | Type IA | Active | pending |
| TGA-2023-0027-V127 | Type II | Active | pending |
| TGA-2023-0027-V227 | Type II | Failed | 2024-02-24 |
| TGA-2023-0027-V327 | Major | Failed | 2023-07-25 |
| TGA-2023-0027-V427 | Minor | In Progress | 2023-08-03 |
Inspection Readiness Risk Panel
Risk Score: 2 · Overdue commitments: 1, failed/blocked sequences: 0, high-risk questions: 0.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.