Table 15 Toolkit developed by HAI-AP to identify irrational FDCs
Requirements | Scenario 1 | Scenario 2 | Scenario 3 | Scenario 4 | Scenario 5 |
|---|---|---|---|---|---|
Rationale for the combination | Not usually | Not usually | ✓ | ✓ | ✓ |
Balancing advantages and disadvantages of the combination | Not usually | Not usually | ✓ | ✓ | ✓ |
Marketing status in other countries | ✓ | ✓ | ✓ | ✓ | ✓ |
Analysis of literature data in the submission | Possibly for pharmaceutical development | Possibly for pharmaceutical development | ✓ | ✓ | ✓ |
Pharmaceutical development studies | ✓ | ✓ | ✓ | ✓ | ✓ |
Good Manufacturing Practice (GMP) certification of sites of manufacture | ✓ | ✓ | ✓ | ✓ | ✓ |
A full quality data set | ✓ | ✓ | ✓ | ✓ | ✓ |
Bioavailability data | Not usually | Not usually | Sometimes | ✓ | ✓ |
Bioequivalence data | ✓ | ✓ | Sometimes | Sometimes | ✓ |
Preclinical pharmacology and safety | Not usually | Not usually | Sometimes | ✓ | ✓ |
Clinical safety and efficacy | Not usually | Not usually | ✓ | ✓ | ✓ |
Product information | ✓ | ✓ | ✓ | ✓ | ✓ |
Plan for passive post marketing surveillance | ✓ | ✓ | ✓ | ✓ | ✓ |
Plan for active post marketing surveillance | Not usually | Not usually | ✓ | ✓ | ✓ |
Assurances | ✓ | ✓ | ✓ | ✓ | ✓ |