TY - JOUR

T1 - The wider use of fixed-dose combinations emphasizes the need for a global approach to regulatory guideline development

AU - Gautam, Yvonne

AU - Bjerrum, Ole Jannik

AU - Schmiegelow, Merete

PY - 2015

Y1 - 2015

N2 - A fixed-dose combination (FDC) is a drug product in which two or more separate drug components (active pharmaceuticalingredients) are combined in a single-dosage form. Interest in developing FDCs is increasing in a range of diseases. This projectinvestigated 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 ofFDCs. These concerns were presented to key informants from both the EU and US regulatory authorities. It was clear from theresults that the current regulatory environment for FDCs lacks consistency. This may create a barrier to innovation movingfrom the laboratory to the clinic, as companies cannot clearly see the development path requirements. This project also highlightedcertain challenges that currently face the regulatory world: how to improve the role of regulatory science and provideclear quantification in assessment decisions; the role of guidelines and their impact on innovation; and, most important, thequestion of globalization and how to move toward a more harmonized regulatory system.

AB - A fixed-dose combination (FDC) is a drug product in which two or more separate drug components (active pharmaceuticalingredients) are combined in a single-dosage form. Interest in developing FDCs is increasing in a range of diseases. This projectinvestigated 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 ofFDCs. These concerns were presented to key informants from both the EU and US regulatory authorities. It was clear from theresults that the current regulatory environment for FDCs lacks consistency. This may create a barrier to innovation movingfrom the laboratory to the clinic, as companies cannot clearly see the development path requirements. This project also highlightedcertain challenges that currently face the regulatory world: how to improve the role of regulatory science and provideclear quantification in assessment decisions; the role of guidelines and their impact on innovation; and, most important, thequestion of globalization and how to move toward a more harmonized regulatory system.

KW - Faculty of Health and Medical Sciences

KW - fixed-dose combination

KW - guidelines

KW - drug combinations

KW - medicines

KW - deveopment

KW - innovation

KW - regulatory science

KW - global

U2 - 10.1177/2168479014543699

DO - 10.1177/2168479014543699

M3 - Journal article

VL - 49

SP - 197

EP - 204

JO - Therapeutic Innovation & Regulatory Science

JF - Therapeutic Innovation & Regulatory Science

SN - 2168-4790

IS - 1

ER -