549 - A company is entering into a new disease state in which they don't already market a product in Canada.If they produce a corporate ad (pre NOC) indicating that they are now entering into the therapeutic area/disease state, can they mention the therapeutic area/disease state in the ad?

  • In the context of a corporate message, a company can discuss the areas in which it is doing research regardless of whether it has an approved product for that condition. There are regulatory provisions you need to be aware of when creating such pieces. For example, as per C.08.002 of the Food and Drug Regulations, advertising must not allude to products which have not yet been approved for use in Canada. The PAAB preclearance system will help you discuss the therapeutic area in a manner which is consistent with the regulations. As a general comment, a message that “Company X is doing research in condition Y” would enable you to accomplish your stated goal.