HC-2024-0046
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-046
Application Number
HC-2024-0046
Procedure Type
NDS
Status
Approved
Linked Product
Market Authorization
Taiwan · HC
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-046 | CTD | 3.8.5 | 5 | M1 (15), M2 (8), M3 (12), M4 (11), M5 (7) | In Progress |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Request for additional clinical data on primary endpoint | 2025-03-09 | low | Open |
| Question on comparative dissolution data | 2025-03-07 | high | In Progress |
| Question on comparative dissolution data | 2025-01-12 | medium | In Progress |
| Deficiency: inadequate paediatric data justification | 2025-04-24 | low | Overdue |
| Deficiency letter: missing stability data for 40°C condition | 2025-04-24 | low | Overdue |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Implement Risk Minimisation Measures (RMM) per REMS requirements | 2025-01-05 | medium | In Progress |
| Validate analytical method for dissolution test per USP <711> | 2024-12-11 | medium | Open |
| Provide 36-month accelerated stability data for 25°C/60% RH condition | 2025-12-05 | low | Overdue |
| Submit harmonised global label per ICH Q12 PLCR | 2025-09-14 | medium | Overdue |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-136 | SmPC | 2.0 | In Progress |
| LBL-137 | SmPC | 1.1 | In Progress |
| LBL-138 | PIL | 4.2 | Active |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| HC-2024-0046-V046 | Type IB | Blocked | 2022-08-03 |
| HC-2024-0046-V146 | Type IB | Failed | pending |
| HC-2024-0046-V246 | Major | Completed | pending |
| HC-2024-0046-V346 | Minor | Blocked | 2023-12-03 |
| HC-2024-0046-V446 | Type IA | Draft | pending |
Inspection Readiness Risk Panel
Risk Score: 7 · Overdue commitments: 2, failed/blocked sequences: 1, high-risk questions: 1.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.