This document provides guidance on the clinical development strategy for a fixed combination medicinal product.
The guidance applies primarily to small molecules irrespective of route of administration and dosage form (immediate versus modified release), but the general principles also apply to biological products. The scientific principles are also applicable to a substance designed to dissociate in vivo into two or more active substances that form its principal therapeutic moieties.
The guideline does not apply to a single molecule active substance that affects multiple pharmacological targets (i.e. has affinity to multiple receptors involved in the desired therapeutic outcome). The guideline primarily discusses the development of fixed combination medicinal products with two active substances. However, it is expected that the same principles would generally apply to fixed combination medicinal products containing three or more active substances. The guideline does not address the requirements for combination packs, i.e. where active substances are included in separate pharmaceutical forms marketed in the same package. The clinical development of herbal fixed combinations as well as those composed of vitamins, oligo-elements and minerals are also outside of the scope of this guideline