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Fixed dose combinations (FDCs)

The development of fixed-dose combinations (FDCs) is becoming increasingly important from a public health perspective. Such combinations of drugs are being used in the treatment of a wide range of conditions and are particularly useful in the management of HIV/AIDS, malaria and tuberculosis, which are considered to be the foremost infectious disease threats in the world today.

FDCs have advantages when there is an identifiable patient population for whom treatment with a particular combination of actives in a fixed ratio of doses has been shown to be safe and effective and when all of the actives contribute to the overall therapeutic effect. In addition there can be real clinical benefits in the form of increased efficacy and/or a reduced incidence of adverse effects, but such claims should be supported by evidence. Additional advantages of FDCs are potentially lower costs of manufacturing compared to the costs of producing separate products administered concurrently, simpler logistics of distribution, improved patient adherence and reduced development of resistance in the case of antimicrobials. Importantly, as for any new medicine the risks and benefits should be defined and compared.

The attached guidelines are intended to provide advice to those countries that do not as yet have guidelines for this type of products. It will also provide guidance to industry when developing new products and when considering the regulatory requirements that will need to be met.

The various scenarios considered in the draft guidance are essentially the same as those in the draft "Scientific and technical principles for fixed dose combination drug products" that followed a meeting of interested parties held in Botswana in March 2004 (see attached link for further information).