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The "Month Without Tobacco" initiative is a public health campaign that is part of the National Tobacco Reduction Program (NRTEP 2014-2019). All the actions of the ANSM make it a recognized player in this program, in which it participates in the framework of the Cancer Plan.

The main missions of ANSM, to provide equitable access to innovation in terms of health products and to guarantee the safety of use of these products throughout their life cycle, are available for the drugs used in the help with smoking cessation.

These drugs are currently divided into two types: nicotine replacement therapy (as a transdermal patch, chewing gum, lozenge, inhaler, spray) or chemical treatments.

The ANSM intervenes for all these products:

• in the framework of their Marketing Authorization (MA), whether in the national or European procedure, and in the context of their follow-up, in particular in terms of pharmacovigilance, by the evaluation of data relating both to the pharmaceutical quality, only in animal data and data in humans (efficacy and safety).
• upstream of these MAs, by assisting laboratories in the development of new products or new galenic forms, whether through scientific advice or the evaluation of clinical trial authorization applications.
• at the level of advertising, in particular that made to the public. With a view to public health, smoking cessation products can thus be the subject of promotional campaigns to the general public and visa applications for these drugs are subject to control and, where appropriate, a authorization a priori by the ANSM.

ANSM works as a partner with the Ministry of Health and other health authorities to promote the fight against tobacco, considered a priority of Public Health. In particular, she took part in national and European discussions during the emergence of electronic cigarettes in 2012 and is regularly asked by the Directorate General for Health (DGS) to take part in work related to stopping smoking, by example for the management of smoking cessation. She is currently part of a DGS focus group on vaping, for which she established an information point in 2016.

Finally, the ANSM participated in the development of good practices in the framework of the stop of the tobacco, established by the High authority of health (HAS) in 2014, because of its expertise on the evaluation of the drugs used in smoking cessation.

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The A3P Association is a major player in the pharmaceutical and biotechnology industry.
Created in 1986, it contributes to the good development of the production of medicines and clean and sterile equipment, it runs a network of professionals 21 000, manufacturers and suppliers, as part of International Congress and technical days.

It now has over 1700 members who share their technical experience, scientific and regulatory.

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