TFDA-2024-0091
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-091
Application Number
TFDA-2024-0091
Procedure Type
BLA
Status
Approved
Linked Product
Market Authorization
United States · TFDA
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-091 | CTD | 6.9.2 | 5 | M1 (14), M2 (6), M3 (5), M4 (4), M5 (11) | Failed |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Information request: manufacturing process change justification | 2024-12-15 | medium | Open |
| Information request: manufacturing process change justification | 2024-12-06 | medium | In Progress |
| Request for updated SmPC section 4.1 | 2024-12-23 | low | Draft |
| Query: container closure integrity study methodology | 2025-01-07 | low | In Progress |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Submit final study report for paediatric use study KCL-PED-001 | 2025-07-10 | medium | Blocked |
| Provide carcinogenicity study report for 2-year rat study | 2025-05-05 | medium | Blocked |
| Submit final study report for paediatric use study KCL-PED-001 | 2025-01-14 | medium | Overdue |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-271 | IFU | 11.5 | In Progress |
| LBL-272 | IFU | 1.3 | In Progress |
| LBL-273 | Labeling | 14.6 | Approved |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| TFDA-2024-0091-V091 | Minor | Submitted | pending |
| TFDA-2024-0091-V191 | Type IB | Completed | pending |
| TFDA-2024-0091-V291 | Type II | Failed | 2024-01-01 |
| TFDA-2024-0091-V391 | Type IB | Completed | 2024-04-15 |
| TFDA-2024-0091-V491 | Type II | Pending | 2023-01-11 |
Inspection Readiness Risk Panel
Risk Score: 6 · Overdue commitments: 1, failed/blocked sequences: 2, high-risk questions: 0.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.