COFEPRIS-2021-0034
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-034
Application Number
COFEPRIS-2021-0034
Procedure Type
Lifecycle Extension
Status
Blocked
Linked Product
Market Authorization
China · COFEPRIS
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-034 | CTD | 6.3.2 | 5 | M1 (8), M2 (10), M3 (3), M4 (7), M5 (6) | Approved |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Deficiency letter: missing stability data for 40°C condition | 2025-03-14 | low | Draft |
| Request for benefit-risk assessment addendum | 2025-03-24 | low | Draft |
| Query regarding bioequivalence study design | 2025-03-21 | low | Draft |
| Request for additional clinical data on primary endpoint | 2025-04-16 | high | Open |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Complete Phase IV post-marketing observational study (n=500) | 2025-12-27 | low | Overdue |
| Complete Phase IV post-marketing observational study (n=500) | 2025-09-27 | medium | Open |
| Submit annual PSUR covering the period Jan 2024 – Dec 2024 | 2024-11-29 | medium | Blocked |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-100 | SmPC | 11.1 | In Progress |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| COFEPRIS-2021-0034-V034 | Minor | Overdue | 2024-02-28 |
| COFEPRIS-2021-0034-V134 | Major | Completed | 2024-03-06 |
| COFEPRIS-2021-0034-V234 | Minor | Completed | pending |
| COFEPRIS-2021-0034-V334 | Type IA | Failed | pending |
| COFEPRIS-2021-0034-V434 | Major | Overdue | 2024-05-30 |
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.