TFDA-2024-0051
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-051
Application Number
TFDA-2024-0051
Procedure Type
NDS
Status
Pending
Linked Product
Market Authorization
Turkey · TFDA
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-051 | eCTD | 5.2.3 | 5 | M1 (4), M2 (4), M3 (4), M4 (13), M5 (8) | Blocked |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Request for additional clinical data on primary endpoint | 2025-04-25 | high | Draft |
| Request for benefit-risk assessment addendum | 2025-01-22 | high | Draft |
| Information request: extractables and leachables data | 2024-12-09 | high | Open |
| Deficiency letter: missing stability data for 40°C condition | 2025-03-01 | low | Draft |
| Request for additional clinical data on primary endpoint | 2024-12-01 | medium | Open |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Implement Risk Minimisation Measures (RMM) per REMS requirements | 2025-06-29 | high | Blocked |
| Provide carcinogenicity study report for 2-year rat study | 2025-09-02 | medium | Open |
| Submit final study report for paediatric use study KCL-PED-001 | 2024-12-04 | medium | Blocked |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-151 | PIL | 1.6 | Approved |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| TFDA-2024-0051-V051 | Type II | Failed | pending |
| TFDA-2024-0051-V151 | Type IA | Draft | 2022-08-26 |
| TFDA-2024-0051-V251 | Type IB | Pending | 2023-12-15 |
| TFDA-2024-0051-V351 | Type II | Submitted | 2022-12-05 |
| TFDA-2024-0051-V451 | Major | Failed | 2023-11-28 |
Inspection Readiness Risk Panel
Risk Score: 5 · Overdue commitments: 0, failed/blocked sequences: 1, high-risk questions: 3.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.