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

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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:

English (EN) (278.37 KB - PDF)

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Open consultation

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

Draft: consultation open Consultation dates: to Reference Number: EMA/21378/2026 Summary:

Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.

English (EN) (705.63 KB - PDF)

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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: to 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.

English (EN) (98.22 KB - PDF)

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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:

English (EN) (278.37 KB - PDF)

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Megtekintés

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

English (EN) (166.13 KB - PDF)

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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

English (EN) (97.61 KB - PDF)

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