187 - What type of guidance is there regarding the inclusion of product pipelines in Canadian corporate websites?
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Promotion of a drug prior to market authorization would contravene Section C.08.002 of the Food and Drugs Regulations). Note that one also needs to consider the consumer regulations as corporate sites are open to the general public. Given these two considerations, it is critical to ensure that the activity is not promotional. Please refer to the Health Canada document "The Distinction Between Advertising and Other Activities".
The following guidance is particularly relevant to this specific question:
- the content should be directed to shareholders or potential shareholders. On a website, this could be achieved by including the content in the "Investor Information/Relations" tab.
- the content should be limited to the name of the drug and its proposed therapeutic use (e.g. chemical x for condition Y is in phase II studies).
- no statement can be made regarding the degree of safety or efficacy expected and no comparisons should be drawn with other treatments.
- the document should not be emphasized and it should be devoid of promotional statements
- the content should include a prominent disclaimer that the products have not been approved.
