New Drugs are regulated under Part C, Division 8 of the Food and Drug Regulations ( and require the filing of a New Drug Submission (NDS). Information on this process and requirements are provided via the links below. New Drug Submissions must be supported by data obtained from non-clinical and clinical trials, conducted in accordance with international standards, or scientific rationales, to support the quality, safety, and efficacy of the New Drug.

The data requirement may vary according to the inhaled product and associated health claims (e.g. smoking cessation, temporary abstinence). Pharmacokinetic data, addictive properties, long-term safety (local and systemic), bystander exposure and the possibility of overdosage are examples of important issues/ information that would need to be addressed in the NDS. The fact that non-smoker could use this product and develop addiction is another issue that would need to be addressed in the submission.

As well, the nicotine delivery system component of the electronic smoking product is considered to be a Class II medical device. In order to sell this device in Canada, the manufacturer must first obtain an ISO 13485:2003 CMDCAS certificate from one of Health Canada's recognized registrars. Once this certification has been obtained, the manufacturer must submit a Class II medical device licence application to the Medical Devices Bureau.


2.1 Basic preclinical/clinical fee
Your basic fee depends on your primary (route/dosage form/condition of use) from Section 1.4.
Your basic fee is the first applicable item on the following list. Determine your basic fee, then
enter this amount on line 101.
a) If the data package to support your primary (route/dosage form/condition of use)
contains preclinical and clinical data, your basic fee is $117,000.
b) If the data package to support your primary (route/dosage form/condition of use)
contains clinical data without preclinical data, your basic fee is $52,900.
c) If the data package to support your primary (route/dosage form/condition of use)
contains clinical data with supplementary or confirmatory preclincial data, your basic
fee is $52,900.
d) If the data package to support your primary (route/dosage form/condition of use)
contains comparative (clinical, bioavailability or pharmacodynamic) data, your basic fee
is $17,200. (i.e. ANDS)
e) If the data package to support your primary (route/dosage form/condition of use)
contains only published clinical references or other published data, your basic fee is
$2,200.

f) If your submission contains no data included in a) to e), your basic fee is $0.