CDSCO-2022-0093
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-093
Application Number
CDSCO-2022-0093
Procedure Type
NDS
Status
Pending
Linked Product
Market Authorization
Japan · CDSCO
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-093 | NeeS | 7.4.9 | 5 | M1 (10), M2 (8), M3 (11), M4 (3), M5 (11) | Submitted |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Request for post-marketing commitment progress update | 2025-03-06 | medium | Open |
| GMP inspection findings clarification | 2025-01-08 | low | Overdue |
| Request for updated SmPC section 4.1 | 2025-02-07 | medium | Draft |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Submit annual PSUR covering the period Jan 2024 – Dec 2024 | 2025-01-26 | high | In Progress |
| Provide carcinogenicity study report for 2-year rat study | 2025-03-23 | low | Overdue |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-277 | Labeling | 19.9 | In Progress |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| CDSCO-2022-0093-V093 | Type IA | Pending | 2022-09-07 |
| CDSCO-2022-0093-V193 | Minor | Approved | 2023-12-16 |
| CDSCO-2022-0093-V293 | Type IA | Submitted | pending |
| CDSCO-2022-0093-V393 | Type IB | Overdue | 2023-11-22 |
| CDSCO-2022-0093-V493 | Type IB | Submitted | pending |
Inspection Readiness Risk Panel
Risk Score: 6 · Overdue commitments: 1, failed/blocked sequences: 2, high-risk questions: 0.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.