Afin de soutenir la demande croissante, nous avons modifé la section Demandez au CCPP et l'avons rendu plus facile d'utilisation. Vous pouvez désormais sélectioner la catégorie qui vous interesse dans le menu déroulant et voir les questions qui ont déjà été posées et répondues. Vous pouvez également faire une recherche parmis les questions déjà soumises au CCPP depuis les débuts.
Questions et réponses les plus récentes
We have a question regarding controlled distribution/gating of a website containing information intended for HCPs. We understand that options for creating an acceptable barrier include "URL of a website which is not indexed" (as presented during Jennifer Carroll's talk "From Email to Virtual Reality" during PAAB's 2017 National Workshop). However, we are unable to find any further information from PAAB or from Health Canada regarding what "not indexed" means in this context. Can you please elaborate, or point us to guidance documentation outlining what "not indexed" means for a site's URL, in order to create an acceptable barrier for the site?
Please see ask PAAB question 418. As additional guidance, keep in mind the url should be something that is NOT easily guessed (i.e. www.productname.ca) and is submitted to PAAB as part of the website review. Please contact your IT department for specific instructions on how to de-index your website.
Hi there, Can the wording "NOW APPROVED IN CANADA" be PAAB exempt for a 2nd indication? Thanks
The following guidance is provided under the assumption that this is the entire content of the piece. The Food and Drug Regulations prohibit discussion of the approval process within advertising. If we were to reframe the question to a message of “Now available in Canada”, while the message itself would be considered exempt from PAAB review, it is still advertising and subject to the standards of the PAAB code. Messages of “new” are restricted to one year post marketing. Stating that the product is “now available” without limiting the claim to the new 2nd indication, would be misleading. The 2nd indication would need to be included to accurately limit the ”new” claim and this would render the piece non-exempt. See code section 1.5D for a list of exempt messages.
Hi, we have a new product in our pipeline that is currently undergoing an approval process with Health Canada and is targeting a specific biomarker. We would like to do a campaign to HCPs regarding this specific biomarker and to raise the physician's awareness of this biomarker as an emerging target for a particular disease. Is such campaign acceptable, considering that no mechanism of action nor information on the pipeline will be discussed?
The intent of a pre-launch editorial APS should be to increase health care professional awareness and understanding of a specific therapeutic area, or in this case a specific biomarker. These APS should not contain the message that a new product (or indication) is coming soon as this could be construed as pre-NOC advertising and contravene section C.08.002 of the Food and Drug Regulations. Discussion of how an exogenous compound may modulate a pathway would be rejected as it alludes to a new drug coming to market. Likewise, we would question the message that this biomarker is an emerging target for the disease, this would be construed as pre-NOC advertising. As this APS is targeting HCPs, it should be submitted for PAAB review.
We would like to make non-clinical comparisons between products that are specifically indicated for different subtypes of a disease state (eg. phenotypes of COPD). Would this be acceptable, given the common umbrella disease state?
No. The specific indication for each product must be the same. If the products are indicated in different subtypes, they are not considered to have the same indication and therefore should not be compared. See code section 5.1 and 5.2
We have an ongoing pivotal study and would like to report the latest published data. While the data exceeds the duration of that mentioned in the TMA, it is directionally-consistent with respect to magnitude/significance, and no additional safety concerns were identified. Can we report this data in APS, if there is no emphasis placed on the duration?
No. PAAB review is based on the Health Canada approved terms of market authorization. Published studies must be consistent with and within the limitations of the TMA to be considered for inclusion in advertising. Consistency with the TMA is assessed based on a number of parameters, including the duration of the study. If an ongoing study goes beyond the duration of use within the TMA, this would be deemed to be outside of the limitations of the TMA. Copy indicating that Health Canada has reviewed and accepted the efficacy and safety of the product for the extended duration would be required prior to assessing the acceptability of the data in advertising. Please see response to question 585 as well: No. The data from the later analysis can only be included in the piece once it is included in the TMA
For a piece containing TMA dosage forms and dosing instructions, but no therapeutic/pharmacological claims, would low-level balance be sufficient?
The document “Tips and checklist for creating and selecting fair balance” on the PAAB website provides a list of questions that can help you determine what level of fair balance is required based on the messaging within the piece. A presentation where the highest level of messaging is restricted to dosing and administration information such as “dosage form” and “dosing instructions” would fall under the category of “Non-pharmacologic claims” Lowest level fair balance is sufficient to balance non-pharmacologic type claims.
For an HCP targeted APS, are references required in the final layout of the piece after PAAB approval (i.e., a reference list at the end of the piece and superscripts throughout)? Or do references not need to be included in the layout once PAAB has approved the copy doc? Thanks!
For HCP targeted advertising, references are required in the final layout of the piece. Yes, as you said, this entails a reference list at the end of the piece and the corresponding superscripts throughout the piece. An alternative is to use the superscripts throughout the piece but include the corresponding reference list in a web location corresponding to a URL presented on the piece. See the PAAB code sections 4.4.3 to 4.4.7.
This is required for adherence to PAAB code section 3.3 (i.e. an HCP would need to know which reference to request from the manufacturer if he/she wanted additional info or wanted to test the evidentiary basis for a claim).
Hi; I have a questions regarding usage of the trade mark of the competitor in the promo materials. The owning promo material company wants to include the registered information from the competitor's PM. would it be acceptable to use the competitor's registered trademark in the piece? Thank you
It may or may not be acceptable to use content from a competitor’s PM so your question may be found to become moot (if in doubt, you may want to submit a written opinion before you go too far – see the fee schedule on our website). Nonetheless, in response to a more general question about competitor trademarks such as the trade name, yes we’ve approved their use in advertising. Make sure you acknowledge competitor’s trademarks per PAAB code section 5.17. This is not a legal opinion. If you have more specific questions regarding trademark use or if you are considering something out of the norm, I suggest you consult with your legal department.
Hi PAAB. I would like to inquire about the requirements for PAAB material review relating to a company-sponsored symposia (non CME/CHE accredited) being held at an International congress occurring in Canada. The symposia is being developed by the sponsors Global team, with both speakers internal to the organization and some external. If there is no mention of any specific licensed product during the presentations, is PAAB material review required? In another scenario, if case-studies related to a licensed product(s) (vaccine) in Canada were included in the presentation material to provide practical examples and inform the clinical discussion, would the materials require PAAB review? Thanks very much
This was considered when we first created the eFile system for the very reason you suggested. On the surface, it appears to be a good idea, but it was deemed at the time not to be practical. Itemized correspondence letters appear to be a more efficient way (for clients and PAAB) to engage in the back-and-forth that frequently occurs during the review process. The copydeck would get quite crowded with the reasoning and counter-reasoning defending each party’s position. This would be true whether the comments appeared directly on the copydeck or as digital sticky notes. The lion’s share of the time use appears to be due to the back and forths. It might therefore be counter-productive to take a step which could impair either party’s ability to follow the flow of reasoning and counter-reasoning. Keep in mind that the reasoning or counter-reasoning in a single correspondence for a single comment can sometimes be multiple pages long. This was the thinking at the time. Years have passed and technology has evolved so feel free to reach out to me if you have ideas on how the system can be improved.