HSA-2023-0032
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-032
Application Number
HSA-2023-0032
Procedure Type
sBLA
Status
Draft
Linked Product
Market Authorization
European Union · HSA
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-032 | NeeS | 4.2.7 | 5 | M1 (14), M2 (5), M3 (13), M4 (11), M5 (15) | In Progress |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Request for updated SmPC section 4.1 | 2025-02-06 | high | Open |
| Information request: extractables and leachables data | 2025-04-09 | low | Open |
| Query: container closure integrity study methodology | 2025-04-10 | high | Open |
| Query regarding bioequivalence study design | 2025-04-17 | high | In Progress |
| Request for benefit-risk assessment addendum | 2025-04-17 | high | In Progress |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Implement Risk Minimisation Measures (RMM) per REMS requirements | 2025-09-27 | medium | Open |
| Provide confirmatory bioequivalence study for 200 mg strength | 2025-04-06 | high | In Progress |
| Complete Phase IV post-marketing observational study (n=500) | 2025-09-30 | medium | Blocked |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-094 | Labeling | 16.0 | Active |
| LBL-095 | SmPC | 8.1 | In Progress |
| LBL-096 | IFU | 1.5 | Approved |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| HSA-2023-0032-V032 | Type II | Draft | pending |
| HSA-2023-0032-V132 | Minor | Failed | 2022-12-30 |
| HSA-2023-0032-V232 | Minor | Failed | 2023-03-17 |
| HSA-2023-0032-V332 | Type IA | Completed | 2023-06-27 |
| HSA-2023-0032-V432 | Minor | Active | pending |
Inspection Readiness Risk Panel
Risk Score: 4 · Overdue commitments: 0, failed/blocked sequences: 0, high-risk questions: 4.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.