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
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draft guidance are essentially the same as those in the draft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).