CDSCO-2022-0033
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-033
Application Number
CDSCO-2022-0033
Procedure Type
Type IB Variation
Status
Active
Linked Product
Market Authorization
Japan · CDSCO
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-033 | CTD | 4.5.8 | 5 | M1 (3), M2 (11), M3 (10), M4 (6), M5 (4) | Submitted |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Query regarding bioequivalence study design | 2025-03-10 | low | Draft |
| Question on comparative dissolution data | 2024-12-30 | medium | Draft |
| Information request: extractables and leachables data | 2024-12-17 | medium | Open |
| GMP inspection findings clarification | 2025-02-16 | high | Draft |
| GMP inspection findings clarification | 2025-01-07 | medium | Draft |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Provide carcinogenicity study report for 2-year rat study | 2025-08-07 | low | Overdue |
| Submit final study report for paediatric use study KCL-PED-001 | 2025-10-16 | low | In Progress |
Linked Labeling and Variations
| Variation | Type | Status | Submitted |
|---|---|---|---|
| CDSCO-2022-0033-V033 | Major | In Progress | 2023-10-01 |
| CDSCO-2022-0033-V133 | Minor | Submitted | pending |
| CDSCO-2022-0033-V233 | Minor | Submitted | 2023-03-04 |
| CDSCO-2022-0033-V333 | Type IA | Draft | pending |
| CDSCO-2022-0033-V433 | Type II | Draft | 2024-02-21 |
Inspection Readiness Risk Panel
Risk Score: 5 · Overdue commitments: 1, failed/blocked sequences: 1, high-risk questions: 1.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.