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We are developing a multi-product lowest level APS regarding a Patient Support Program (PSP) for enrolling patients into the PSP via website (online portal). The APS is generalized, one page document with several product names and instructions to access the website and contact numbers. No therapeutic or Pharmacologic claims are available. Therefore, could you please clarify whether it is acceptable if the indication statement is not included in this piece. Thank you.

Hi @sonalip9 It’s an interesting question and at face value might seem rational to think an expiry is illogical. However, the regulatory landscape for pharmaceutical advertising direct-to-consumers is more complex than “name, price, quantity”. There are linkages to consider, the totality of marketing campaigns which change over time as well as continuously updated rulings from Health Canada on what is deemed to align with federal regulations. It may not be possible for companies to be aware of all review rulings and understand if they impact their DTCA campaigns. The expiry date encourages companies to stay proactive about regulatory compliance and reassessment to occur in the context of the current market and regulatory environment, not the market of 1, 2 or 3 years past. If the concern is the cost and effort associated with maintaining a file’s acceptance status, we encourage you to utilize the new Renewals Management Dashboard. It was designed to help streamline your renewal submissions and track upcoming renewals. When a renewal is submitted 6 weeks or more in advance of the prior eFile’s expiry, it may be eligible for the early renewal discount, which is 50% off the associated full fee. Rest assured, if you renew early your new acceptance period for the new file will not begin until the end of the prior file’s acceptance period. You can learn more about the Renewals Management Dashboard here.

Good Morning @Manufacturer and @Agency Hope everyone is staying warm and enjoying the ️. The PAAB Quarterly Tag and CEI Reports have been updated to contain data for Q4. See the Tag report here and the CEI report here. The Forum Quarterly Review for Q4 has also been posted. These wrap up 2024! Thank you for another great year of collaboration and compliance. We hope to continue working with you in 2025 Thank you PAAB

Is patient consent information required to be clearly, visually separated from HCP information on a PSP form? I have seen examples of forms that have been approved where the only "visual separation" is that the patient information is in a separate box labelled "patient consent" but there is no different in colour, for example, versus the HCP information, whereas on other approved forms, the patient box is in a different colour than the HCP information. Would that be sufficient? I've also seen a comment that the patient should not be able to see the indication information on the form. Why would this be? The patient has obviously been prescribed the product if they are being enrolled in the program, so why would this be an issue?

Hi @caitlinbyrne When an APS has more than one audience, all regulations for each audience apply. The tool would be reviewed to ensure it meets patient and HCP regulations. Generally the patient regulations are more stringent so we recommend strongly considering them when creating the tool.

Hello @tbalzarini Thank you for bringing this to our attention. We will update shortly. In the meantime, the Health Canada “Guidance on Distinction Between Advertising and Other Activities for Health Products” resource should be consulted.

Can you please clarify if pooled long-term extension data can be considered, assuming the original pivotal studies are part of the TMA? I've review the guidance on duration of clinical trials and it seems to assume that the LTE is the continuation of a single study. What if there is a pre-planned open-label LTE where patients from the various pivotal trials are fed into one pooled LTE?