TFDA-2024-0011
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-011
Application Number
TFDA-2024-0011
Procedure Type
Type IB Variation
Status
Overdue
Linked Product
Market Authorization
France · TFDA
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-011 | CTD | 6.5.0 | 5 | M1 (7), M2 (13), M3 (10), M4 (7), M5 (9) | Overdue |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Query regarding bioequivalence study design | 2025-01-23 | low | Overdue |
| Request for benefit-risk assessment addendum | 2025-02-04 | high | Draft |
| Request for benefit-risk assessment addendum | 2025-04-07 | medium | Open |
| Query regarding bioequivalence study design | 2024-12-05 | medium | Draft |
| Deficiency letter: missing stability data for 40°C condition | 2024-12-06 | medium | Draft |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Update SmPC section 4.4 with hepatic impairment data | 2025-09-11 | high | Overdue |
| Provide 36-month accelerated stability data for 25°C/60% RH condition | 2024-11-15 | medium | Overdue |
| Implement Risk Minimisation Measures (RMM) per REMS requirements | 2025-09-18 | low | Overdue |
Linked Labeling and Variations
| Variation | Type | Status | Submitted |
|---|---|---|---|
| TFDA-2024-0011-V011 | Type IB | Approved | pending |
| TFDA-2024-0011-V111 | Major | Blocked | 2023-10-14 |
| TFDA-2024-0011-V211 | Type II | Failed | 2022-09-06 |
| TFDA-2024-0011-V311 | Type IA | Pending | 2022-08-24 |
| TFDA-2024-0011-V411 | Major | Blocked | 2023-01-21 |
Inspection Readiness Risk Panel
Risk Score: 7 · Overdue commitments: 3, failed/blocked sequences: 0, high-risk questions: 1.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.