NMPA-2021-0064
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-064
Application Number
NMPA-2021-0064
Procedure Type
sMAA
Status
Pending
Linked Product
Market Authorization
China · NMPA
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-064 | eCTD | 3.8.1 | 5 | M1 (8), M2 (13), M3 (14), M4 (13), M5 (15) | Approved |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Request for benefit-risk assessment addendum | 2024-12-11 | high | Open |
| Request for post-marketing commitment progress update | 2025-04-05 | medium | In Progress |
| Query: container closure integrity study methodology | 2025-02-11 | low | In Progress |
| Information request: manufacturing process change justification | 2025-01-30 | medium | In Progress |
| Information request: manufacturing process change justification | 2025-04-26 | medium | In Progress |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Provide confirmatory bioequivalence study for 200 mg strength | 2025-03-25 | high | Blocked |
| Provide carcinogenicity study report for 2-year rat study | 2025-12-23 | medium | In Progress |
| Provide confirmatory bioequivalence study for 200 mg strength | 2025-12-06 | medium | Overdue |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-190 | Labeling | 10.5 | In Progress |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| NMPA-2021-0064-V064 | Type IB | Failed | pending |
| NMPA-2021-0064-V164 | Type IA | Completed | 2022-10-27 |
| NMPA-2021-0064-V264 | Type II | Completed | pending |
| NMPA-2021-0064-V364 | Type IA | Submitted | 2022-12-07 |
| NMPA-2021-0064-V464 | Type IA | Approved | 2023-06-10 |
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.