NMPA-2021-0024
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-024
Application Number
NMPA-2021-0024
Procedure Type
Type IA Variation
Status
Completed
Linked Product
Market Authorization
Russia · NMPA
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-024 | CTD | 3.9.5 | 5 | M1 (9), M2 (11), M3 (4), M4 (11), M5 (13) | Approved |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Request for additional clinical data on primary endpoint | 2025-04-06 | medium | Overdue |
| GMP inspection findings clarification | 2025-04-04 | low | In Progress |
| Request for additional clinical data on primary endpoint | 2025-04-19 | low | In Progress |
| Information request: extractables and leachables data | 2025-01-06 | high | Draft |
| Question on comparative dissolution data | 2025-01-06 | medium | In Progress |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Provide 36-month accelerated stability data for 25°C/60% RH condition | 2025-09-01 | medium | Blocked |
| Complete Phase IV post-marketing observational study (n=500) | 2025-12-22 | medium | Overdue |
| Submit annual PSUR covering the period Jan 2024 – Dec 2024 | 2025-09-05 | medium | Blocked |
| Submit annual PSUR covering the period Jan 2024 – Dec 2024 | 2025-12-19 | medium | Overdue |
Linked Labeling and Variations
| Variation | Type | Status | Submitted |
|---|---|---|---|
| NMPA-2021-0024-V024 | Major | Failed | pending |
| NMPA-2021-0024-V124 | Minor | Blocked | pending |
| NMPA-2021-0024-V224 | Minor | Completed | pending |
| NMPA-2021-0024-V324 | Type II | Pending | 2023-12-14 |
| NMPA-2021-0024-V424 | Type II | Active | 2023-05-20 |
Inspection Readiness Risk Panel
Risk Score: 5 · Overdue commitments: 2, failed/blocked sequences: 0, high-risk questions: 1.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.