Evaluation of drugs for the treatment of gastroesophageal reflux disease (GORD) - Scientific guideline

This document addresses the European regulatory position on the development of products for the treatment of gastro-oesophageal reflux disease in adults and children.

Keywords: Gastro-oesophageal reflux disease (GORD), reflux oesophagitis, non-erosive reflux disease (NERD)

Current effective version

Guideline on the evaluation of drugs for the treatment of gastro-oesophageal reflux disease

Adopted Consultation dates: 17/12/2009 to 30/06/2010 Reference Number: EMA/CHMP/EWP/342691/2009 Legal effective date: 01/10/2011

Document history

Guideline on the evaluation of drugs for the treatment of gastro-oesophageal reflux disease

Adopted Consultation dates: 17/12/2009 to 30/06/2010 Reference Number: EMA/CHMP/EWP/342691/2009 Legal effective date: 01/10/2011

Overview of comments received on 'guideline on the evaluation of drugs for the treatment of gastro-oesophageal reflux disease'

Reference Number: EMA/131448/2011

Draft guideline on the evaluation of drugs for the treatment of gastroesophageal reflux disease

Draft: consultation closed Consultation dates: 17/12/2009 to 30/06/2010 Reference Number: EMEA/CHMP/EWP/342691/2009

Concept paper on the need for a guideline on the evaluation of drugs for the treatment of Gastroesophageal Reflux disease (GERD)

Consultation dates: 01/02/2009 to 31/05/2009 Reference Number: EMEA/CHMP/EWP/15839/2009