PMDA-2022-0003
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-003
Application Number
PMDA-2022-0003
Procedure Type
Type IB Variation
Status
Approved
Linked Product
Market Authorization
Japan · PMDA
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-003 | CTD | 6.5.3 | 5 | M1 (3), M2 (12), M3 (12), M4 (6), M5 (5) | Pending |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Query regarding bioequivalence study design | 2025-01-19 | low | Overdue |
| Request for updated SmPC section 4.1 | 2025-01-10 | low | Draft |
| Query regarding bioequivalence study design | 2025-03-23 | low | In Progress |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Provide confirmatory bioequivalence study for 200 mg strength | 2025-08-25 | medium | Open |
| Submit annual PSUR covering the period Jan 2024 – Dec 2024 | 2026-01-06 | medium | Overdue |
| Complete Phase IV post-marketing observational study (n=500) | 2025-12-28 | medium | Overdue |
| Submit harmonised global label per ICH Q12 PLCR | 2025-09-27 | medium | In Progress |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-007 | PIL | 15.5 | Pending |
| LBL-008 | PIL | 15.0 | Approved |
| LBL-009 | SmPC | 5.9 | In Progress |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| PMDA-2022-0003-V003 | Minor | Failed | 2023-08-04 |
| PMDA-2022-0003-V103 | Type IA | In Progress | 2023-12-29 |
| PMDA-2022-0003-V203 | Minor | Draft | 2023-12-30 |
| PMDA-2022-0003-V303 | Type IA | Approved | 2023-05-08 |
| PMDA-2022-0003-V403 | Type IB | Overdue | 2023-09-04 |
Inspection Readiness Risk Panel
Risk Score: 4 · Overdue commitments: 2, failed/blocked sequences: 0, high-risk questions: 0.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.