PMDA-2022-0083
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-083
Application Number
PMDA-2022-0083
Procedure Type
Type II Variation
Status
Blocked
Linked Product
Market Authorization
South Africa · PMDA
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-083 | eCTD | 2.2.8 | 5 | M1 (5), M2 (8), M3 (9), M4 (12), M5 (7) | Active |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Information request: extractables and leachables data | 2025-03-21 | low | In Progress |
| Query: container closure integrity study methodology | 2025-04-11 | medium | In Progress |
| Information request: manufacturing process change justification | 2025-03-11 | high | In Progress |
| GMP inspection findings clarification | 2025-01-16 | medium | In Progress |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Complete Phase IV post-marketing observational study (n=500) | 2025-10-21 | high | Open |
| Complete Phase IV post-marketing observational study (n=500) | 2025-02-04 | high | In Progress |
| Submit harmonised global label per ICH Q12 PLCR | 2025-01-22 | high | In Progress |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-247 | IFU | 2.5 | Approved |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| PMDA-2022-0083-V083 | Minor | Approved | 2024-01-05 |
| PMDA-2022-0083-V183 | Minor | Submitted | pending |
| PMDA-2022-0083-V283 | Type IA | Approved | pending |
| PMDA-2022-0083-V383 | Type IB | Draft | pending |
| PMDA-2022-0083-V483 | Type II | Failed | 2024-02-04 |
Inspection Readiness Risk Panel
Risk Score: 1 · Overdue commitments: 0, failed/blocked sequences: 0, high-risk questions: 1.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.