TITCK-2024-0096
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-096
Application Number
TITCK-2024-0096
Procedure Type
Type IB Variation
Status
Blocked
Linked Product
Market Authorization
Canada · TITCK
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-096 | CTD | 8.5.8 | 5 | M1 (3), M2 (14), M3 (7), M4 (3), M5 (15) | Draft |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Query: container closure integrity study methodology | 2024-12-06 | medium | Draft |
| Query regarding bioequivalence study design | 2025-04-29 | medium | In Progress |
| Information request: extractables and leachables data | 2024-12-25 | low | Draft |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Implement Risk Minimisation Measures (RMM) per REMS requirements | 2025-01-06 | high | Blocked |
| Submit annual PSUR covering the period Jan 2024 – Dec 2024 | 2025-04-21 | medium | In Progress |
| Submit annual PSUR covering the period Jan 2024 – Dec 2024 | 2025-03-27 | medium | Blocked |
| Provide confirmatory bioequivalence study for 200 mg strength | 2025-01-08 | medium | Overdue |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-286 | SmPC | 1.5 | In Progress |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| TITCK-2024-0096-V096 | Type IB | Draft | 2024-05-12 |
| TITCK-2024-0096-V196 | Type IB | Blocked | 2024-03-19 |
| TITCK-2024-0096-V296 | Type IB | Overdue | pending |
| TITCK-2024-0096-V396 | Type II | Completed | 2024-02-15 |
| TITCK-2024-0096-V496 | Type II | Pending | 2022-09-09 |
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.