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

  • Email
  • Help

Document details

Download document Concept paper on the need to revise the guideline on the clinical development of fixed-dose combinations of medicinal products regarding dossier content requirements
Reference number EMA/CHMP/779887/2012
Status draft: consultation closed
First published 01/03/2013
Last updated 01/03/2013

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.