CDSCO-2022-0053
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-053
Application Number
CDSCO-2022-0053
Procedure Type
Type II Variation
Status
Overdue
Linked Product
Market Authorization
South Africa · CDSCO
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-053 | CTD | 4.6.7 | 5 | M1 (7), M2 (12), M3 (6), M4 (13), M5 (7) | Completed |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| GMP inspection findings clarification | 2025-03-08 | medium | Open |
| GMP inspection findings clarification | 2025-04-12 | low | In Progress |
| Query: container closure integrity study methodology | 2025-01-22 | medium | Overdue |
| Request for additional clinical data on primary endpoint | 2025-02-12 | medium | Open |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Submit harmonised global label per ICH Q12 PLCR | 2025-02-16 | low | Blocked |
| Provide confirmatory bioequivalence study for 200 mg strength | 2025-02-07 | low | Overdue |
| Submit harmonised global label per ICH Q12 PLCR | 2025-07-10 | medium | In Progress |
Linked Labeling and Variations
| Variation | Type | Status | Submitted |
|---|---|---|---|
| CDSCO-2022-0053-V053 | Minor | Active | pending |
| CDSCO-2022-0053-V153 | Major | Draft | 2023-06-23 |
| CDSCO-2022-0053-V253 | Type II | Overdue | pending |
| CDSCO-2022-0053-V353 | Type IB | Overdue | 2022-11-14 |
| CDSCO-2022-0053-V453 | Type II | Pending | 2024-01-09 |
Inspection Readiness Risk Panel
Risk Score: 4 · Overdue commitments: 1, failed/blocked sequences: 1, high-risk questions: 0.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.