PMDA-2022-0063
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-063
Application Number
PMDA-2022-0063
Procedure Type
NDS
Status
Pending
Linked Product
Market Authorization
Japan · PMDA
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-063 | NeeS | 8.3.7 | 5 | M1 (14), M2 (5), M3 (10), M4 (12), M5 (12) | Submitted |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Deficiency letter: missing stability data for 40°C condition | 2025-04-14 | medium | Draft |
| Request for post-marketing commitment progress update | 2024-12-30 | medium | Overdue |
| Deficiency letter: missing stability data for 40°C condition | 2024-12-23 | low | Draft |
| Question on comparative dissolution data | 2024-12-07 | high | In Progress |
| Query: container closure integrity study methodology | 2025-03-23 | low | Overdue |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Provide confirmatory bioequivalence study for 200 mg strength | 2025-09-04 | medium | In Progress |
| Provide 36-month accelerated stability data for 25°C/60% RH condition | 2025-12-25 | high | Overdue |
| Submit annual PSUR covering the period Jan 2024 – Dec 2024 | 2025-03-22 | medium | Blocked |
| Validate analytical method for dissolution test per USP <711> | 2024-11-05 | low | Open |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-187 | PIL | 9.3 | Approved |
| LBL-188 | PIL | 17.3 | In Progress |
| LBL-189 | SmPC | 13.0 | In Progress |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| PMDA-2022-0063-V063 | Major | Draft | 2023-01-17 |
| PMDA-2022-0063-V163 | Major | Active | 2023-03-25 |
| PMDA-2022-0063-V263 | Type IB | In Progress | 2023-09-20 |
| PMDA-2022-0063-V363 | Major | Active | 2024-03-22 |
| PMDA-2022-0063-V463 | Type II | Approved | 2023-01-16 |
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.