TITCK-2024-0016
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-016
Application Number
TITCK-2024-0016
Procedure Type
sBLA
Status
Pending
Linked Product
Market Authorization
Taiwan · TITCK
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-016 | NeeS | 5.1.3 | 5 | M1 (7), M2 (10), M3 (5), M4 (7), M5 (3) | Overdue |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Request for updated SmPC section 4.1 | 2025-03-28 | high | Overdue |
| Question on comparative dissolution data | 2025-03-27 | medium | Draft |
| Deficiency letter: missing stability data for 40°C condition | 2025-02-01 | medium | Draft |
| Deficiency letter: missing stability data for 40°C condition | 2025-02-08 | medium | Overdue |
| Request for post-marketing commitment progress update | 2025-01-21 | medium | Overdue |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Submit harmonised global label per ICH Q12 PLCR | 2025-08-07 | medium | Overdue |
| Implement Risk Minimisation Measures (RMM) per REMS requirements | 2025-04-12 | low | Open |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-046 | Labeling | 14.8 | Approved |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| TITCK-2024-0016-V016 | Type IB | Draft | pending |
| TITCK-2024-0016-V116 | Type IA | Active | 2022-12-06 |
| TITCK-2024-0016-V216 | Type IA | Overdue | 2023-01-26 |
| TITCK-2024-0016-V316 | Major | Approved | 2022-11-18 |
| TITCK-2024-0016-V416 | Type IB | Pending | 2022-11-11 |
Inspection Readiness Risk Panel
Risk Score: 9 · Overdue commitments: 1, failed/blocked sequences: 3, high-risk questions: 1.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.