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We have Data on File that was part of an NDS, but was not explicitly included in the TMA. We feel Health Canada has 'accepted' this DOF, by virtue of related label negotiations and direct correspondence. What type of proof would PAAB require to consider use of the DOF in APS: Sponsor Regulatory confirmation, Sponsor correspondence with Health Canada, contacting Health Canada directly on behalf of the Sponsor, etc?
The PAAB may consider correspondence between the manufacturer and Health Canada when those correspondence clearly indicate Health Canada approval. When this cannot be determined to be the case, PAAB may need to contact Health Canada directly on behalf of the sponsor in order to confirm approval of the referenced DOF. Note that submission as part of the NDS does not in and of itself confirm that the content has been approved by Health Canada.
A disease-state piece includes mention of treatments in a balanced manner. It is distributed to consumers as a Consumer Brochure and technically exempt. Can this same piece be distributed to HCPs, or would it have to be revised to meet Editorial APS requirements? Does the content and/or level of detail dictate this?
Distribution of a piece which discusses treatment options to healthcare professionals, would require review under the PAAB code. The copy would be reviewed to ensure that it meets editorial APS requirements (PAAB Code section 7.5). Please note that “Consumer Brochures” are not considered exempt from PAAB review as they do not fall under the PAAB code (they are outside of the scope of the PAAB code). The PAAB does offer an advisory opinion on consumer brochures based on Health Canada policy documents. The following link provides the roles of the various regulatory bodies within Canada: https://www.canada.ca/en/health-canada/services/drugs-health-products/regulatory-requirements-advertising/policies-guidance-documents/advertising-preclearance-agencies-health-product.html
Will PAAB approve MOA comparison around selectivity in an unbranded leave behind - content is not from individual TMAs but from recent post-NOC invitro peer reviewed paper?
The description of a product’s MOA must be consistent with and within the limitations of the current Terms of Market Authorization. See Ask PAAB responses to questions 512 and 309 for further details. We caution that unbranded advertising must contain objective, balanced and scientifically rigorous information with no emphasis on information specifically about the sponsor’s product. Selectively choosing a comparison/topic which favours the sponsors drug is not acceptable in unbranded advertising. For more specific information about the reference in question, we suggest submitting this information for an opinion (see the fee schedule on our website).
For non-prescription marketed health products, is it a requirement to include a product's DIN or NPN on an advertisement/promotional piece directed at a healthcare professional?
No, the DIN or NPN are not generally required.
We would like to do an unbranded piece based on treatment guidelines. There are no Canadian treatment guidelines for this disease. Can we use a European guideline (not for a particular country but from a European society (endorsed or recognized by an authoritative medical body)? Can we use two guidelines together, the European and the US guideline? If some of the products are not authorized in the same way in Canada as recommended in the guidelines, should we not mention that use or we should clarify that is not the way that is indicated in Canada? Thank you for your help.
For place in therapy and treatment goals we look first to Canadian consensus guidelines, to ensure consistency with current Canadian medical opinion. (s3.2) In the absence of Canadian guidelines we can consider US or North American guidelines. In the absence of those, we can consider international guidelines. When an international guideline is being submitted, we require authoritative support that the International guidelines are endorsed by a recognized Canadian health professional organization representing this therapeutic area.
In the scenario described above where guidelines lower in the aforementioned hierarchy are being used over the available US guidelines, evidence must be provided to support that these guidelines are a true reflection of Canadian practice. A letter from the recognized Canadian health professional organization for the particular therapeutic area is required to clearly support that the international guidelines are endorsed and more widely used by Canadian HCPs than the recent American guidelines (i.e. An official statement from the organization (not a personal letter from a KOL) on official letterhead demonstrating that it has been vetted by the entire group).
With respect to off-label content, guidelines cannot be used to support advertising content which extend beyond a product’s monograph, even in unbranded advertising. Off-label uses should not be mentioned.
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HI PAAB, when a drug goes from pre-NOC to NOC, is it possible to use the wording "Now Approved In Canada". Also, if this is marketed to general population, does it need PAAB approval? Thanks
In response to your question regarding PAAB preclearance, consumer advertising does not require PAAB review. However, PAAB does provide an advisory opinion for consumer advertising which is recognized by Health Canada. We offer this review for prescription drugs, vaccines, and ethical drugs. As stated in Q&A 347, Health Canada has asked preclearance bodies to question claims of “now approved” per section C.01.007 of the Food and Drug Regulations.
As clarified in Q&A 501, Health Canada has stated that it considers the statement “Product X is authorized for sale by Health Canada” to be acceptable in advertising as long as it is not presented in a context implying endorsement or recommendation by Health Canada and no reference is made to the legislation or approval process. The link to the minutes for that meeting can be found on the PAAB website: http://paab.ca/2015_RoD_final.pdf
Hello, We plan to create a survey to gather statistics on lifestyle habits and general knowledge of the respondents on a virus in order to use the said metrics in a promotional tool, in the vaccination field. 1000 respondents is the usual number needed to produce relevant or serious statistics. The question is: As per PAAB's guidelines, is there a minimum number of respondents needed in a survey to be able to use the statistics produced by it in promotional tools. Thank you
The PAAB requires the methodology to be valid, and part of this (only one part of this) is the number of respondents. There is no single set criteria around the number of participants needed. Ultimately, what is considered reasonable with regards to the survey size depends on several factors including but not limited to the research question and the condition. For example, we can appreciate that some conditions don’t have 1000 patients in North America. Please see Ask PAAB question 551 for more relevant information.
Hi there, I am currently creating a slide deck that the reps will use with their customers, and I am wondering how PAAB would like market research to be referenced? Is the project name, source, and date sufficient, or is there more information that PAAB requires? Thanks!
As per PAAB code section 4.4.4, the reference citation format should be clear and complete. The PAAB does not dictate the specific format in which references are provided.
I would like to clarify the requirements for a PAAB material review in relation to a US-only promotional symposium at an international congress held in Canada. Our US colleagues would like to host a learning theatre program on a product that is approved for use in both the US and Canada. If the program is US-developed (independent of Canadian input) and presented to a US-Healthcare professionals audience only, is the material developed subject to PAAB review? A few mitigation steps would be in place: • All learning event promotional tools (such as the invitation) will state that Canadian physicians and any Canadian healthcare professionals (HCPs) will not have access to this event. • A check-in safeguard system will be set up at the entry of the event (such as checking and scanning the badges) to ensure access is only granted to US-HCPs. • A disclaimer will be included at the bottom of each slide of the presentation clearly stating that all information is based on the US prescribing information • The local internal review team will review and attest to the presence of this disclaimer before the slide deck can be used at the event. Thank you in advance.
If Canadian HCPs will not have access to the event and auxiliary materials, this would be out of the scope of the PAAB code. PAAB Preclearance is not required. We assume from the question that Canadian HCPs would not be targeted with invitations.
Jennifer Carroll
Réviseur principal en communications
Le Conseil Consultatif de
