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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 | ✓ | ✓ | ✓ | ✓ | ✓ |
