COFEPRIS-2021-0094
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-094
Application Number
COFEPRIS-2021-0094
Procedure Type
Type IB Variation
Status
Blocked
Linked Product
Market Authorization
China · COFEPRIS
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-094 | eCTD | 1.9.8 | 5 | M1 (5), M2 (6), M3 (5), M4 (8), M5 (9) | In Progress |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Request for updated SmPC section 4.1 | 2025-03-16 | medium | Overdue |
| Request for additional clinical data on primary endpoint | 2025-03-12 | medium | Open |
| Question on comparative dissolution data | 2025-03-31 | medium | Draft |
| Query regarding bioequivalence study design | 2025-03-06 | medium | Draft |
| Request for post-marketing commitment progress update | 2025-03-18 | medium | Draft |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Submit final study report for paediatric use study KCL-PED-001 | 2025-09-13 | low | In Progress |
| Submit harmonised global label per ICH Q12 PLCR | 2025-10-23 | medium | Open |
| Provide 36-month accelerated stability data for 25°C/60% RH condition | 2025-07-17 | high | Overdue |
| Implement Risk Minimisation Measures (RMM) per REMS requirements | 2025-11-08 | medium | In Progress |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-280 | IFU | 9.2 | In Progress |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| COFEPRIS-2021-0094-V094 | Type II | Draft | 2022-08-06 |
| COFEPRIS-2021-0094-V194 | Minor | Draft | 2022-08-14 |
| COFEPRIS-2021-0094-V294 | Type IA | In Progress | pending |
| COFEPRIS-2021-0094-V394 | Type IB | Pending | pending |
| COFEPRIS-2021-0094-V494 | Type IA | Active | 2022-07-25 |
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.