PMDA-2022-0023
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-023
Application Number
PMDA-2022-0023
Procedure Type
Lifecycle Extension
Status
In Progress
Linked Product
Market Authorization
South Africa · PMDA
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-023 | NeeS | 1.0.6 | 5 | M1 (13), M2 (4), M3 (12), M4 (8), M5 (9) | Completed |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Question on comparative dissolution data | 2025-02-26 | medium | In Progress |
| Question on comparative dissolution data | 2025-03-05 | medium | Open |
| Information request: extractables and leachables data | 2024-12-24 | medium | Open |
| Request for additional clinical data on primary endpoint | 2024-12-10 | medium | Open |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Provide carcinogenicity study report for 2-year rat study | 2024-12-24 | low | In Progress |
| Submit annual PSUR covering the period Jan 2024 – Dec 2024 | 2025-02-02 | medium | Blocked |
| Submit final study report for paediatric use study KCL-PED-001 | 2025-05-26 | medium | Overdue |
| Submit harmonised global label per ICH Q12 PLCR | 2025-03-26 | high | Open |
Linked Labeling and Variations
| Variation | Type | Status | Submitted |
|---|---|---|---|
| PMDA-2022-0023-V023 | Minor | Pending | 2023-02-05 |
| PMDA-2022-0023-V123 | Major | Submitted | 2024-01-05 |
| PMDA-2022-0023-V223 | Major | Blocked | 2024-01-13 |
| PMDA-2022-0023-V323 | Major | Active | 2022-08-31 |
| PMDA-2022-0023-V423 | Type II | Failed | 2023-03-11 |
Inspection Readiness Risk Panel
Risk Score: 2 · Overdue commitments: 1, failed/blocked sequences: 0, high-risk questions: 0.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.