Clinical development of fixed combination medicinal products - Scientific guideline

Revision 2 replaces 'Guideline on clinical development of fixed combination medicinal products' (CHMP/EWP/240/95 Rev. 1). This guideline covers fixed combination medicinal products containing two or more active substances within a single pharmaceutical form. The active substances may be authorised substances or substances that have not yet been authorised in the EU.

Keywords: Fixed combination medicinal products, guidance, clinical development

Current effective version

Guideline on clinical development of fixed combination medicinal products - Revision 2

Adopted Reference Number: EMA/CHMP/158268/2017 Legal effective date: 01/10/2017

Document history

Guideline on clinical development of fixed combination medicinal products - Revision 2

Adopted Reference Number: EMA/CHMP/158268/2017 Legal effective date: 01/10/2017

Overview of comments on 'Draft guideline on clinical development of fixed combination medicinal products - Revision 2 (EMA/CHMP/281825/2015)'

Reference Number: EMA/757184/2015

Draft guideline on clinical development of fixed combination medicinal products - Revision 2

Draft: consultation closed Consultation dates: 13/05/2015 to 15/11/2015 Reference Number: EMA/CHMP/281825/2015 Summary:

This guideline addresses the clinical development requirements of fixed combination medicinal products, which shall reflect their intended therapeutic use and indication. It replaces the guideline on clinical development of fixed combination medicinal products - CHMP/EWP/240/95 Rev. 1.

Concept paper on the need to revise the guideline on the clinical development of fixed-dose combinations of medicinal products regarding dossier content requirements - Revision 2

Draft: consultation closed Consultation dates: 01/03/2013 to 31/05/2013 Reference Number: EMA/CHMP/779887/2012 Summary:

The current guideline contains a section describing the legal basis applicable to fixed-dose-combination (FDC)-product marketing-authorisation application. There is a need to revise the current version of this guideline in order to suppress regulatory aspects from the guideline and restrict it to the scientific requirements for clinical development of fixed combinations, regardless of the chosen legal basis.

Guideline on clinical development of fixed combination medicinal products - Revision 1

Adopted Reference Number: CHMP/EWP/240/95 Rev. 1 Legal effective date: 01/09/2009

Overview of comments received on draft guideline on fixed combinations - Revision 1

Reference Number: EMEA/CHMP/EWP/533066/2008

Draft guideline on fixed combination medicinal products - Revision 1

Draft: consultation closed Reference Number: CPMP/EWP/240/95 Rev. 1