Development of new medicinal products for the treatment of smoking - Scientific guideline

This 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.

Keywords: Tobacco, smoking, nicotine dependence

Current effective version

Guideline on the development of medicinal products for the treatment of smoking

Adopted Reference Number: CHMP/EWP/369963/05 Legal effective date: 01/07/2009

Document history

Concept paper on the need for revision of the guideline on the development of medicinal products for the treatment of smoking

Draft: consultation open Consultation dates: 29/05/2026 to 30/08/2026 Reference Number: EMA/112569/2026 Summary:

The scope of the current guideline is to provide guidance in the definition of treatment goals, study design, outcome measures, and data analysis for new medicinal products that will be developed to treat nicotine dependence in support of an indication for the treatment of tobacco smoking. 

There has been a rapid development of essentially tobacco-free recreational products containing nicotine for inhalation (e.g. electronic cigarettes) and oromucosal use (e.g. snuff) in the EU. Addiction to tobacco-free nicotine products has become an increasing problem, especially in the adolescent and young adult populations.

The current guideline is not intended for and is neither completely applicable for development of medicinal products for the treatment of the addiction to non-smoking nicotine products. Nevertheless, as no other guideline applies in those cases, the guideline for smoking cessation is still the most relevant. To meet the treatment needs arising from the new types of nicotine addiction, adjustments of this guideline are proposed for the document to be fully applicable for all types of nicotine dependence.

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

Overview of comments received on the draft guideline on the development of medicinal products for the treatment of smoking (EMEA/CHMP/EWP/369963/05)

Reference Number: EMEA/432157/2009

Draft guideline on the development of medicinal products for the treatment of nicotine dependence

Draft: consultation closed Reference Number: CHMP/EWP/369963/05

Concept paper on the development of a guideline on the development of new products for the treatment of tobacco and alcohol dependence

Reference Number: EMEA/CHMP/EWP/369963/2005