COFEPRIS-2021-0054
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-054
Application Number
COFEPRIS-2021-0054
Procedure Type
sNDA
Status
Blocked
Linked Product
Market Authorization
Russia · COFEPRIS
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-054 | eCTD | 8.5.4 | 5 | M1 (3), M2 (7), M3 (12), M4 (5), M5 (12) | Draft |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Request for post-marketing commitment progress update | 2024-12-31 | high | Open |
| Request for additional clinical data on primary endpoint | 2025-05-07 | high | Overdue |
| Query: container closure integrity study methodology | 2025-02-17 | low | In Progress |
| Request for benefit-risk assessment addendum | 2025-04-07 | medium | In Progress |
| Request for updated SmPC section 4.1 | 2025-03-16 | high | Draft |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Provide confirmatory bioequivalence study for 200 mg strength | 2025-02-15 | high | Open |
| Update SmPC section 4.4 with hepatic impairment data | 2024-12-18 | low | Blocked |
| Validate analytical method for dissolution test per USP <711> | 2025-11-12 | high | Open |
| Submit harmonised global label per ICH Q12 PLCR | 2025-05-20 | high | Blocked |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-160 | SmPC | 9.4 | Active |
| LBL-161 | PIL | 16.1 | In Progress |
| LBL-162 | Labeling | 12.6 | In Progress |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| COFEPRIS-2021-0054-V054 | Type IA | Overdue | 2023-01-11 |
| COFEPRIS-2021-0054-V154 | Minor | Blocked | 2023-08-24 |
| COFEPRIS-2021-0054-V254 | Type II | Blocked | 2022-09-16 |
| COFEPRIS-2021-0054-V354 | Minor | Overdue | pending |
| COFEPRIS-2021-0054-V454 | Type IB | Overdue | pending |
Inspection Readiness Risk Panel
Risk Score: 3 · Overdue commitments: 0, failed/blocked sequences: 0, high-risk questions: 3.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.