Development of new medicinal products for the treatment of smoking

Current effective version

PDF iconAdopted guideline

Reference numberCHMP/EWP/369963/2005
Published18/12/2008
Effective from01/07/2009
KeywordsTobacco, smoking, nicotine dependence
DescriptionThis document provides guidance in the definition of treatment goals, study design, outcome measures, and data analysis for new products that will be developed to treat nicotine dependence.


Document history

First version

Current version

PDF iconAdopted guideline


PDF iconOverview of comments


PDF iconDraft guideline


PDF iconConcept paper

In operation: 01/07/2009–present


Published: 25/03/2010


Published: 19/07/2009


Published: 17/11/2005


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