TFDA-2024-0071
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-071
Application Number
TFDA-2024-0071
Procedure Type
Type IB Variation
Status
Completed
Linked Product
Market Authorization
France · TFDA
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-071 | NeeS | 7.1.7 | 5 | M1 (14), M2 (6), M3 (9), M4 (8), M5 (9) | Active |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Question on comparative dissolution data | 2025-01-03 | low | Open |
| Information request: extractables and leachables data | 2025-03-04 | medium | Overdue |
| Request for additional clinical data on primary endpoint | 2024-12-11 | medium | Open |
| Query: container closure integrity study methodology | 2024-12-27 | low | In Progress |
| Deficiency letter: missing stability data for 40°C condition | 2025-04-18 | medium | In Progress |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Implement Risk Minimisation Measures (RMM) per REMS requirements | 2025-10-05 | medium | Overdue |
| Complete Phase IV post-marketing observational study (n=500) | 2025-06-20 | medium | Blocked |
| Provide confirmatory bioequivalence study for 200 mg strength | 2025-01-24 | low | Overdue |
| Submit final study report for paediatric use study KCL-PED-001 | 2025-01-19 | low | In Progress |
Linked Labeling and Variations
| Variation | Type | Status | Submitted |
|---|---|---|---|
| TFDA-2024-0071-V071 | Type II | Overdue | 2023-02-06 |
| TFDA-2024-0071-V171 | Minor | Draft | pending |
| TFDA-2024-0071-V271 | Major | Submitted | pending |
| TFDA-2024-0071-V371 | Type IB | Blocked | 2022-10-25 |
| TFDA-2024-0071-V471 | Type IB | Submitted | 2024-01-14 |
Inspection Readiness Risk Panel
Risk Score: 4 · Overdue commitments: 2, failed/blocked sequences: 0, high-risk questions: 0.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.