Statement on the classification of insulin products and duration of action: Notice to stakeholders

Date published: August 6, 2020


After conducting a class review of Product Monographs for various insulin products authorized in Canada over time, Health Canada has concluded that insulin/insulin analogue products in Canada have been classified or described in their respective Product Monographs in an inconsistent manner that could be confusing for both health professionals and patients, especially when they need or wish to compare the properties of insulin products. In addition, this inconsistency might pose risks when switching from one insulin product to another.  As a result, Health Canada requests that sponsors address inconsistencies in the description of the duration of activity and classification of insulin products described in different Product Monographs.


Current insulin Product Monographs contain different information regarding pharmacodynamic and pharmacokinetic properties for each insulin product. An insulin product means a drug product that contains either insulin or an insulin analogue as its active ingredient; excipients may contribute to the properties of the drug product.  

The product monograph is a document included by Health Canada as part of the Notice of Compliance respecting a New Drug Submission or, when appropriate, a Supplement to a New Drug Submission, an Abbreviated New Drug or a Supplement to an Abbreviated New Drug Submission.  The product monograph serves the following purposes:


Health Canada requests that sponsors revise the Pharmacodynamics subsection under the Action and Clinical Pharmacology section in the Product Monographs, for all their insulin/insulin analogue products with regard to the following elements:

Throughout the product monograph, the classification for each insulin/insulin analogue product should be congruent with the World Health Organization (WHO) nomenclature and the Anatomical Therapeutic Chemical (ATC) classification. The product types listed in guidance for the treatment of diabetics who require insulin are:

If the product formulation contains insulin types with different durations of action, then the insulin product should be classified as specified above, and it should be made clear that the insulin product has two durations of action. Sponsors should review all their insulin Product Monographs and update in accordance with this notice. In all cases, the classification should be presented as indicated above. 

Effective date

These amendments in the form of the appropriate submission type are requested to be filed within 6 months from the posting of this notice.  If needed, please contact Health Canada for further guidance and clarification.

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