Roszdravnadzor-2021-0019
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-019
Application Number
Roszdravnadzor-2021-0019
Procedure Type
sBLA
Status
Approved
Linked Product
Market Authorization
Mexico · Roszdravnadzor
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-019 | CTD | 6.6.8 | 5 | M1 (11), M2 (3), M3 (9), M4 (13), M5 (10) | Approved |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Request for additional clinical data on primary endpoint | 2025-03-03 | medium | Overdue |
| Question on comparative dissolution data | 2025-01-26 | low | In Progress |
| GMP inspection findings clarification | 2025-03-23 | high | Open |
| Information request: manufacturing process change justification | 2025-04-15 | medium | Open |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Complete Phase IV post-marketing observational study (n=500) | 2025-09-12 | medium | In Progress |
| Validate analytical method for dissolution test per USP <711> | 2025-05-31 | high | Overdue |
| Provide 36-month accelerated stability data for 25°C/60% RH condition | 2025-05-12 | medium | Open |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-055 | SmPC | 2.9 | Pending |
| LBL-056 | Labeling | 2.3 | In Progress |
| LBL-057 | IFU | 18.6 | Pending |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| Roszdravnadzor-2021-0019-V019 | Type II | Submitted | 2023-05-12 |
| Roszdravnadzor-2021-0019-V119 | Type II | Draft | 2023-03-19 |
| Roszdravnadzor-2021-0019-V219 | Minor | In Progress | pending |
| Roszdravnadzor-2021-0019-V319 | Type IA | Failed | 2024-01-07 |
| Roszdravnadzor-2021-0019-V419 | Type IA | Completed | 2024-02-04 |
Inspection Readiness Risk Panel
Risk Score: 3 · Overdue commitments: 1, failed/blocked sequences: 0, high-risk questions: 1.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.