ANMAT-2020-0015
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-015
Application Number
ANMAT-2020-0015
Procedure Type
Lifecycle Extension
Status
Failed
Linked Product
Market Authorization
South Korea · ANMAT
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-015 | CTD | 7.7.8 | 5 | M1 (15), M2 (4), M3 (9), M4 (5), M5 (8) | Pending |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Query: container closure integrity study methodology | 2025-01-06 | medium | Overdue |
| Request for benefit-risk assessment addendum | 2025-01-08 | high | In Progress |
| Request for benefit-risk assessment addendum | 2025-01-19 | high | Overdue |
| Request for post-marketing commitment progress update | 2025-04-12 | high | Draft |
| Query: container closure integrity study methodology | 2025-05-01 | high | Draft |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Provide 36-month accelerated stability data for 25°C/60% RH condition | 2025-10-30 | low | Blocked |
| Complete Phase IV post-marketing observational study (n=500) | 2025-05-01 | medium | Overdue |
| Complete Phase IV post-marketing observational study (n=500) | 2025-09-07 | low | Blocked |
| Complete Phase IV post-marketing observational study (n=500) | 2025-07-31 | high | Open |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-043 | SmPC | 9.6 | Pending |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| ANMAT-2020-0015-V015 | Type IA | Blocked | 2024-06-18 |
| ANMAT-2020-0015-V115 | Type IA | Pending | 2024-02-05 |
| ANMAT-2020-0015-V215 | Type IA | Blocked | pending |
| ANMAT-2020-0015-V315 | Type IA | Overdue | 2022-10-29 |
| ANMAT-2020-0015-V415 | Type IA | Draft | 2023-03-04 |
Inspection Readiness Risk Panel
Risk Score: 8 · Overdue commitments: 1, failed/blocked sequences: 1, high-risk questions: 4.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.