Project IFDCs
Advocacy Campaign to Remove Irrational Fixed-Dose Combinations
The HAIAP advocacy campaign to remove irrational fixed dose combinations (IFDCs) is based on the 39th Report (2005) compiled by the WHO expert committee on specifications for pharmaceutical preparations (WHO technical report series 929). The guidelines developed in the WHO report are intended to provide advice to those countries that do not, as yet have guidelines for FDC’s and to provide guidance to industry when developing new products. The report also underscores that currently there are no specific international guidelines for FDCs.
According to the WHO expert committee on specifications for pharmaceutical preparations (39th report, 2005) a FDC can be defined as follows:
“ A combination of two or more actives in a fixed ratio of doses. This term is used generically to mean a particular combination of actives irrespective of the formulation or brand. It may be administered as single entity products given concurrently or as a finished pharmaceutical product.”
The report also defines finished pharmaceutical products (FPP) as follows:
“A product that has undergone all stages of production, including packaging in its final container and labeling. An FPP may contain one or more actives.”
A fixed dose combination finished pharmaceutical product (FDC-FPP) can be defined as follows:
“A finished pharmaceutical product that contains two or more actives.”
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