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Table 15 Toolkit developed by HAI-AP to identify irrational FDCs

From: Assessment of the availability and rationality of unregistered fixed dose drug combinations in Nepal: a multicenter cross-sectional study

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
  1. This is a requirement