ANMAT-2020-0075
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-075
Application Number
ANMAT-2020-0075
Procedure Type
MAA
Status
Active
Linked Product
Market Authorization
South Korea · ANMAT
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-075 | CTD | 3.5.3 | 5 | M1 (15), M2 (14), M3 (9), M4 (15), M5 (8) | Failed |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Query: container closure integrity study methodology | 2025-03-30 | low | Open |
| Request for updated SmPC section 4.1 | 2024-12-23 | medium | Draft |
| Request for post-marketing commitment progress update | 2024-12-13 | low | Draft |
| Request for additional clinical data on primary endpoint | 2025-02-25 | low | Overdue |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Provide 36-month accelerated stability data for 25°C/60% RH condition | 2025-03-13 | medium | Overdue |
| Complete Phase IV post-marketing observational study (n=500) | 2025-05-01 | low | Open |
| Submit annual PSUR covering the period Jan 2024 – Dec 2024 | 2025-02-24 | low | Blocked |
| Provide carcinogenicity study report for 2-year rat study | 2025-07-24 | medium | Open |
Linked Labeling and Variations
| Variation | Type | Status | Submitted |
|---|---|---|---|
| ANMAT-2020-0075-V075 | Type II | In Progress | 2023-12-31 |
| ANMAT-2020-0075-V175 | Minor | Overdue | 2023-10-23 |
| ANMAT-2020-0075-V275 | Minor | Blocked | pending |
| ANMAT-2020-0075-V375 | Type IB | Failed | pending |
| ANMAT-2020-0075-V475 | Major | Approved | pending |
Inspection Readiness Risk Panel
Risk Score: 2 · Overdue commitments: 1, failed/blocked sequences: 0, high-risk questions: 0.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.