A fixed-dose combination (FDC) is a drug product in which two or more separate drug components (active pharmaceutical
ingredients) are combined in a single-dosage form. Interest in developing FDCs is increasing in a range of diseases. This project
investigated the regulatory environment for FDCs in the EU and US. A review of the FDC guidelines set forth by the EMA, FDA,
and ICH, followed by interviews of key informants in industry, identified 5 main industry concerns related to development of
FDCs. These concerns were presented to key informants from both the EU and US regulatory authorities. It was clear from the
results that the current regulatory environment for FDCs lacks consistency. This may create a barrier to innovation moving
from the laboratory to the clinic, as companies cannot clearly see the development path requirements. This project also highlighted
certain challenges that currently face the regulatory world: how to improve the role of regulatory science and provide
clear quantification in assessment decisions; the role of guidelines and their impact on innovation; and, most important, the
question of globalization and how to move toward a more harmonized regulatory system.