Development of new medicinal products for the treatment of smoking

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Current effective version

Adopted 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

Adopted guideline


Overview of comments


Draft guideline


Concept paper

In operation: 01/07/2009–present


Published: 25/03/2010


Published: 19/07/2009


Published: 17/11/2005


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