Criteria | FDCs* | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
A | B | C | D | E | F | G | H | I | J | K | |
Rationale for the combination | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Balancing advantages and disadvantages of the combination | X | X | X | X | X | X | X | X | X | X | X |
Marketing status in other countries | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Analysis of literature data in the submission | X | X | X | X | X | X | X | X | X | X | X |
Pharmaceutical development studies | X | X | X | X | X | X | X | X | X | X | X |
Good Manufacturing Practice (GMP) certification of sites of manufacture | X | X | X | X | X | X | X | X | X | X | X |
A full quality data set | X | X | X | X | X | X | X | X | X | X | X |
Bioavailability data | X | - | - | - | - | X | X | X | - | - | X |
Bioequivalence data | X | - | - | - | - | - | X | X | - | - | X |
Preclinical pharmacology and safety | X | - | - | - | - | X | X | X | - | - | X |
Clinical safety and efficacy | X | X | X | X | X | X | X | X | X | X | X |
Product information | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Plan for passive post marketing surveillance | X | X | X | X | X | X | X | X | X | X | X |
Plan for active post marketing surveillance | X | X | X | X | X | X | X | X | X | X | X |
Assurances | X | X | X | X | X | X | X | X | X | X | X |