NMPA-2021-0044
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-044
Application Number
NMPA-2021-0044
Procedure Type
sMAA
Status
Completed
Linked Product
Market Authorization
Netherlands · NMPA
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-044 | eCTD | 3.1.6 | 5 | M1 (10), M2 (7), M3 (5), M4 (9), M5 (8) | Overdue |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Query: container closure integrity study methodology | 2025-02-22 | medium | Draft |
| GMP inspection findings clarification | 2025-02-28 | medium | Open |
| Query regarding bioequivalence study design | 2024-12-16 | low | Draft |
| Request for benefit-risk assessment addendum | 2024-12-10 | low | Draft |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Submit final study report for paediatric use study KCL-PED-001 | 2025-02-05 | medium | Open |
| Provide confirmatory bioequivalence study for 200 mg strength | 2025-12-04 | medium | Open |
Linked Labeling and Variations
| Variation | Type | Status | Submitted |
|---|---|---|---|
| NMPA-2021-0044-V044 | Major | Overdue | 2024-02-25 |
| NMPA-2021-0044-V144 | Type IA | Pending | 2024-03-15 |
| NMPA-2021-0044-V244 | Type II | Active | 2024-02-05 |
| NMPA-2021-0044-V344 | Type IA | Draft | 2022-08-22 |
| NMPA-2021-0044-V444 | Type IB | Failed | pending |
Inspection Readiness Risk Panel
Risk Score: 0 · Overdue commitments: 0, failed/blocked sequences: 0, high-risk questions: 0.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.