Commitments Dashboard
Post-approval commitments are tracked in four time buckets: overdue, due within 30 days, 30–60 days, and 60–90 days. Each commitment requires documented evidence of completion. High-priority overdue items are automatically escalated to the Regulatory Affairs lead.
Overdue136
| ID | Description | Category | Due Date | Priority | Status | Owner |
|---|---|---|---|---|---|---|
| COM-001 | Provide 36-month accelerated stability data for 25°C/60% RH … | Pharmacovigilance | 2024-10-27 (217d overdue) | medium | Blocked | Marcus Webb |
| COM-002 | Complete Phase IV post-marketing observational study (n=500)… | Paediatric Study | 2024-12-18 (165d overdue) | high | Overdue | Carlos Mendez |
| COM-009 | Provide confirmatory bioequivalence study for 200 mg strengt… | Paediatric Study | 2025-05-01 (31d overdue) | medium | Overdue | Tomoko Ikeda |
| COM-012 | Provide confirmatory bioequivalence study for 200 mg strengt… | Post-Approval Study | 2025-02-17 (104d overdue) | low | Blocked | Lieselotte van der Berg |
| COM-013 | Update SmPC section 4.4 with hepatic impairment data… | Post-Approval Study | 2024-12-30 (153d overdue) | high | Overdue | Sarah Chen |
| COM-020 | Validate analytical method for dissolution test per USP <711… | Registry Study | 2025-03-01 (92d overdue) | low | In Progress | Aisha Okonkwo |
| COM-022 | Submit final study report for paediatric use study KCL-PED-0… | REMS | 2025-01-02 (150d overdue) | high | Overdue | Dmitri Volkov |
| COM-023 | Provide carcinogenicity study report for 2-year rat study… | Risk Management | 2024-12-24 (159d overdue) | low | In Progress | Nadia Petrova |
Due Within 30 Days18
| ID | Description | Category | Due Date | Priority | Status | Owner |
|---|---|---|---|---|---|---|
| COM-005 | Complete Phase IV post-marketing observational study (n=500)… | REMS | 2025-06-12 (in 11d) | medium | Overdue | Carlos Mendez |
| COM-045 | Provide 36-month accelerated stability data for 25°C/60% RH … | REMS | 2025-06-30 (in 29d) | high | Blocked | James O'Brien |
| COM-052 | Provide confirmatory bioequivalence study for 200 mg strengt… | REMS | 2025-06-21 (in 20d) | low | Overdue | Lieselotte van der Berg |
| COM-067 | Update SmPC section 4.4 with hepatic impairment data… | Labeling Update | 2025-06-28 (in 27d) | high | In Progress | Nadia Petrova |
| COM-080 | Update SmPC section 4.4 with hepatic impairment data… | Labeling Update | 2025-06-05 (in 4d) | high | Overdue | James O'Brien |
| COM-151 | Implement Risk Minimisation Measures (RMM) per REMS requirem… | Paediatric Study | 2025-06-29 (in 28d) | high | Blocked | Sarah Chen |
| COM-171 | Complete Phase IV post-marketing observational study (n=500)… | REMS | 2025-06-20 (in 19d) | medium | Blocked | Tomoko Ikeda |
| COM-214 | Submit harmonised global label per ICH Q12 PLCR… | Risk Management | 2025-07-01 (in 30d) | medium | In Progress | Tomoko Ikeda |
Due in 30–60 Days30
| ID | Description | Category | Due Date | Priority | Status | Owner |
|---|---|---|---|---|---|---|
| COM-008 | Implement Risk Minimisation Measures (RMM) per REMS requirem… | Labeling Update | 2025-07-26 (in 55d) | medium | In Progress | James O'Brien |
| COM-021 | Submit final study report for paediatric use study KCL-PED-0… | Risk Management | 2025-07-02 (in 31d) | high | Overdue | Aisha Okonkwo |
| COM-059 | Submit final study report for paediatric use study KCL-PED-0… | Manufacturing | 2025-07-02 (in 31d) | low | Overdue | Lieselotte van der Berg |
| COM-085 | Provide confirmatory bioequivalence study for 200 mg strengt… | Pharmacovigilance | 2025-07-08 (in 37d) | medium | Overdue | James O'Brien |
| COM-087 | Submit harmonised global label per ICH Q12 PLCR… | Manufacturing | 2025-07-08 (in 37d) | low | Blocked | Carlos Mendez |
| COM-091 | Submit final study report for paediatric use study KCL-PED-0… | Registry Study | 2025-07-10 (in 39d) | medium | Blocked | Priya Sharma |
| COM-102 | Provide confirmatory bioequivalence study for 200 mg strengt… | Manufacturing | 2025-07-26 (in 55d) | high | In Progress | Marcus Webb |
| COM-104 | Validate analytical method for dissolution test per USP <711… | Post-Approval Study | 2025-07-16 (in 45d) | medium | In Progress | Priya Sharma |
Due in 60–90 Days21
| ID | Description | Category | Due Date | Priority | Status | Owner |
|---|---|---|---|---|---|---|
| COM-003 | Provide confirmatory bioequivalence study for 200 mg strengt… | Risk Management | 2025-08-25 (in 85d) | medium | Open | Sarah Chen |
| COM-016 | Submit harmonised global label per ICH Q12 PLCR… | Post-Approval Study | 2025-08-07 (in 67d) | medium | Overdue | James O'Brien |
| COM-017 | Provide carcinogenicity study report for 2-year rat study… | Pharmacovigilance | 2025-08-22 (in 82d) | medium | In Progress | Sarah Chen |
| COM-033 | Provide carcinogenicity study report for 2-year rat study… | Risk Management | 2025-08-07 (in 67d) | low | Overdue | James O'Brien |
| COM-039 | Complete Phase IV post-marketing observational study (n=500)… | Pharmacovigilance | 2025-08-14 (in 74d) | medium | In Progress | James O'Brien |
| COM-077 | Complete Phase IV post-marketing observational study (n=500)… | Labeling Update | 2025-08-22 (in 82d) | medium | Overdue | James O'Brien |
| COM-078 | Provide carcinogenicity study report for 2-year rat study… | Manufacturing | 2025-08-24 (in 84d) | low | Open | Sarah Chen |
| COM-081 | Update SmPC section 4.4 with hepatic impairment data… | REMS | 2025-08-14 (in 74d) | medium | Blocked | Tomoko Ikeda |