ANVISA-2020-0045
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-045
Application Number
ANVISA-2020-0045
Procedure Type
BLA
Status
Submitted
Linked Product
Market Authorization
South Korea · ANVISA
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-045 | CTD | 4.7.4 | 5 | M1 (10), M2 (8), M3 (7), M4 (15), M5 (12) | Pending |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Query regarding bioequivalence study design | 2025-01-06 | medium | Open |
| Request for post-marketing commitment progress update | 2024-12-15 | medium | Draft |
| Question on comparative dissolution data | 2024-12-11 | medium | Open |
| Deficiency: inadequate paediatric data justification | 2025-01-09 | high | Open |
| Question on comparative dissolution data | 2025-02-11 | medium | Overdue |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Provide 36-month accelerated stability data for 25°C/60% RH condition | 2025-06-30 | high | Blocked |
| Provide 36-month accelerated stability data for 25°C/60% RH condition | 2025-09-18 | high | In Progress |
| Implement Risk Minimisation Measures (RMM) per REMS requirements | 2024-12-02 | medium | In Progress |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-133 | Labeling | 14.3 | Pending |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| ANVISA-2020-0045-V045 | Type IB | Pending | 2023-02-12 |
| ANVISA-2020-0045-V145 | Minor | Failed | 2023-05-10 |
| ANVISA-2020-0045-V245 | Type II | Draft | 2022-08-18 |
| ANVISA-2020-0045-V345 | Minor | Draft | 2023-01-11 |
| ANVISA-2020-0045-V445 | Major | Completed | 2022-09-01 |
Inspection Readiness Risk Panel
Risk Score: 5 · Overdue commitments: 0, failed/blocked sequences: 2, high-risk questions: 1.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.