Clinical development of medicinal products for the treatment of cystic fibrosis - Scientific guideline

This document provides guidance on the clinical development and evaluation of medicinal products for the treatment of cystic fibrosis.

Keywords: Antibiotics, cystic fibrosis, exocrine pancreas insufficiency, paediatrics, pancreatic enzymes preparations (PEP), pulmonary disease, pulmonary infection, pseudomonas aeruginosa

Current effective version

Guideline on the clinical development of medicinal products for the treatment of cystic fibrosis - First version

Adopted Reference Number: EMEA/CHMP/EWP/9147/2008 Legal effective date: 30/04/2010

Open consultation

Guideline on the clinical investigation of medicinal products for the treatment of cystic fibrosis

Draft: consultation open Consultation dates: 01/03/2026 to 31/08/2026 Reference Number: EMA/21378/2026 Summary:

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Document history

Concept paper on the need for revision of the guideline on the clinical development of medicinal products for the treatment of cystic fibrosis (CHMP/EWP/9147/2008) - Revision 1

Draft: consultation closed Consultation dates: 01/08/2016 to 31/10/2016 Reference Number: EMA/CHMP/259918/2016 Summary:

The proposed guideline will replace 'guideline on the clinical development of medicinal products for the treatment of cystic fibrosis EMEA/CHMP/EWP/9147/2008 corr.

Guideline on the clinical development of medicinal products for the treatment of cystic fibrosis - First version

Adopted Reference Number: EMEA/CHMP/EWP/9147/2008 Legal effective date: 30/04/2010

Draft guideline on the clinical development of medicinal products for the treatment of cystic fibrosis - First version

Draft: consultation closed Reference Number: EMEA/CHMP/EWP/9147/2008

Concept paper on the need for a guideline on the development of new medicinal products intended for the management and treatment of cystic fibrosis - First version

Reference Number: EMEA/CHMP/EWP/81927/2007