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:
- it contains all the representations to be made in respect of the new drug as required by paragraphs C.08.002(2)(k) and C.08.003(2)(h) of the Food and Drug Regulations
- it fulfils the requirements for adequate directions for the use of new drugs included in a number of Sections having to do with labelling in Parts C and G of the Food and Drug Regulations
- it identifies the information that is to be provided, on request, when a package insert is not included with a new drug product, including when a health professional requests information relevant to clinical use
- it identifies the information that should be provided to the patient regarding the use of that product [for instance, Part III, Patient Medication Information]
- it establishes the limitations/parameters for all advertising, representations, and promotional or information material distributed or otherwise endorsed by the sponsor
- subsection C.08.002(2) of the Food and Drug Regulations prohibits the advertising of a new drug for any use of the drug or for any claim that has not been the subject of a cleared submission
- as this information is represented in the product monograph, no professional or published literature should be quoted, distributed, or otherwise provided by the sponsor if it refers to claims or indications for use that are not supported by the most current product monograph
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:
- the duration of action that is clinically relevant for each insulin product is to be expressed as “The duration of action of xyz insulin is between X and Y hours”
- this will provide consistency in labelling for ease of comparison by health professionals and patients
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:
- fast-acting: crystalline insulin onset is fast and duration is short; usually used before meal time.
- intermediate-acting: special formulations to extend the duration of action of crystalline to NPH or other longer acting insulins
- long-acting: used as basal insulin level to mimic pancreatic function before meal times
- this type of insulin has a variably lasting effect
- the pharmacokinetics may indicate different durations of action, however they need to be administered once a day independently of the pharmacokinetic profile
- intermediate- or long-acting combined with fast-acting: special formulation or high concentration of any of the above
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.
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.
For Biologic and radiopharmaceutical drugs
Office of Regulatory Affairs
Biologic and Radiopharmaceutical Drugs Directorate
100 Eglantine Driveway
Address Locator: 0601C
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