NMPA-2021-0084
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-084
Application Number
NMPA-2021-0084
Procedure Type
Lifecycle Extension
Status
Draft
Linked Product
Market Authorization
Russia · NMPA
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-084 | CTD | 3.6.2 | 5 | M1 (15), M2 (6), M3 (5), M4 (10), M5 (9) | In Progress |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Information request: manufacturing process change justification | 2025-05-06 | high | In Progress |
| GMP inspection findings clarification | 2025-02-12 | medium | Open |
| Request for additional clinical data on primary endpoint | 2025-01-09 | high | Draft |
| Query: container closure integrity study methodology | 2024-12-15 | high | In Progress |
| GMP inspection findings clarification | 2024-12-23 | medium | Open |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Submit final study report for paediatric use study KCL-PED-001 | 2025-08-03 | medium | Open |
| Provide carcinogenicity study report for 2-year rat study | 2025-09-28 | low | Open |
| Implement Risk Minimisation Measures (RMM) per REMS requirements | 2025-10-06 | low | Open |
| Implement Risk Minimisation Measures (RMM) per REMS requirements | 2024-11-25 | low | Blocked |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-250 | IFU | 17.1 | Approved |
| LBL-251 | SmPC | 11.2 | In Progress |
| LBL-252 | Labeling | 8.8 | Pending |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| NMPA-2021-0084-V084 | Type IB | Failed | 2023-04-24 |
| NMPA-2021-0084-V184 | Major | Overdue | 2022-09-01 |
| NMPA-2021-0084-V284 | Type IB | Submitted | 2022-11-21 |
| NMPA-2021-0084-V384 | Type II | Draft | 2022-12-07 |
| NMPA-2021-0084-V484 | Type IA | Pending | 2023-03-06 |
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.