Originally implemented February 1, 2024 - Updated (red) December 19, 2025

Background

In a perfect world, all clinical decisions would be supported by the highest possible quality of evidence. However, in the real world, health professionals don’t typically have the luxury of deferring therapeutic decisions until availability of the highest possible quality of evidence. In fact, in some domains of decision-making, the highest possible quality of evidence may never become available. Health professionals must make decisions based on the best evidence available at the time. With the approach outlined below, we aim to facilitate the delivery of recent research findings to inform healthcare decision-making. This guidance document pertains to Advertising/Promotion Systems (APS) that are directed to health professionals.

Canada has a unique preclearance mechanism for HCP advertising: an impartial review conducted by a specialized body that is completely independent from the manufacturer. This puts Canada’s health product industry in a unique position to leverage potential health benefits from advertising content that informs health professionals of recent findings from a broad spectrum of research types while maintaining a long-standing tradition of truthful and trustworthy advertising.

The guidance provided herein could further promote informed clinician decision-making by ensuring that all research findings are presented responsibly and that the limitations of the evidence are prominently disclosed.

Scope

This guidance document applies to health product advertising directed to health professionals. It is important to note; however, that it does not apply to:

• Class B opioids: In adherence with Health Canada’s Terms and Conditions on advertising for opioids, the advertising for such products is restricted to verbatim extractions from the Terms of Market Authorization (TMA).
• NOC/c products: For products or for specific indications authorized under Notice of Compliance with Conditions (NOC/c), advertising presentations relating to efficacy/effectiveness/safety must be sourced from the TMA. CLICK HERE for additional applicable guidance. The evidentiary and disclosure requirements for NOC/c products differ from those for Notice of Compliance (NOC) products.

Approach for presentations requiring the attention icon

The PAAB’s evidentiary standards for marketing benefit claims are unchanged by this guidance document.

For a list of some of the key relevant resources & guidances CLICK HERE. From this point forward, this guidance document uses the phrase “evidence which meets (or does not meet) the PAAB’s standards for marketing benefit claims” to refer to standards discussed throughout the linked list of Code sections and guidance documents.

Presentations Types requiring the attention icon

In the attached guidance document, users will find the criteria that apply specifically to the evidence type they are trying to present. While aspects of the sections are repeated, the sequential presentations as separate sections allows for the clear and concise description of feature requirements which are specific to the data type being presented.

1. How to format unblinded data presentations for subjective endpoints in APS
2. How to format data based on different formulations in presentations in APS
3. How to format presentations of post-hoc analyses and endpoints that have not been validated in APS for treatments of rare diseases 

1. HOW TO FORMAT UNBLINDED DATA PRESENTATIONS FOR SUBJECTIVE

ENDPOINTS IN APS

The presentation is informational and claim neutral. The data is not used as the basis for EITHER overt claims of benefit OR creative imagery.

Three key elements required in a data presentation based on evidence that does not meet the PAAB’s standards for

marketing benefit claims:

• The presentation is boxed (i.e., grey shading or, for faxes, a black outline)
• The presentation begins with an icon and an explanatory statement on the data source
• The presentation discloses key study limitations (when applicable)

Repetition of the data requires repetition of the icon, explanatory statement and disclosure of key study limitations. This sort of data presentation does not lend itself well to a summary page since it cannot be reduced into a concise/summary format.

These presentation standards are not required for data presentations that are exclusively based on content from the TMA. This applies EVEN if they conflict with other study findings, and/or they don’t pertain to the specific product promoted in the APS.

1.1 The icon

The icon should be presented prominently at the top of the presentation. CLICK HERE for Attention Icon Guidelines.

The alt tag for the icon is “Attention”

1.2 The explanatory statement on the data source

The statement should be presented prominently at the top of the presentation.

An example of an explanatory statement is “The data in this grey box is from an unblinded randomized control trial.

Data relating to subjective endpoints should be interpreted cautiously due to the risk of bias.”

1.3 Disclosure of key study limitations

The statement appears as body copy (i.e., at least 75% of font size of main body copy and is easily legible).

1.4 Considerations for audio/video presentations

Video:

• The explanatory statement on the data source may be included on a title/divider screen prior to the presentation of results instead of on every screen where the data is presented
• A closing statement similar to “The presentation of unblinded data is now concluded” should be included to indicate the end of the presentation

Audio:

• The icon and explanatory statement should be included in the audio. The icon can be read as “Attention”. A single tone may be included prior to the reading of the explanatory statement to provide a break from the regular background noise or pace of audio, thus alerting the listener to pay attention to the audio that immediately follows the tone. (The intention of this tone is to help break up the audio, in a similar way that a visual break would be created in a layout).

2. HOW TO FORMAT DATA BASED ON DIFFERENT FORMULATIONS IN

PRESENTATIONS IN APS

The presentation is informational and claim neutral. The data is not used as the basis for EITHER overt claims of benefit OR creative imagery.

Three key elements required in a data presentation based on evidence that does not meet the PAAB’s standards for marketing benefit claims:

• The presentation is boxed (i.e., grey shading or, for faxes, a black outline)
• The presentation begins with an icon and an explanatory statement on the data source
• The presentation discloses key study limitations (see section 2.3)

Repetition of the data requires repetition of the icon, explanatory statement and disclosure of key study limitations. This sort of data presentation does not lend itself well to a summary page since it cannot be reduced into a concise/summary format.

These presentation standards are not required for data presentations that are exclusively based on content from the TMA. This applies EVEN if they conflict with other study findings, and/or they don’t pertain to the specific product promoted in the APS.

2.1 The icon

The icon should be presented prominently at the top of the presentation. CLICK HERE for Attention Icon Guidelines.

The alt tag for the icon is “Attention”

2.2 The explanatory statement on the data source

The statement should be presented prominently at the top of the presentation and identify all brands where formulations are inconsistent with the Canadian formulation.

An example of an explanatory statement is “The data in this grey box is from a study evaluating the Norwegian formulation of PsoriaMax. The data should be interpreted cautiously as the inactive ingredients are not identical to the Canadian formulation.”

2.3 Disclosure of key study limitations

The statement appears as body copy (i.e., at least 75% of font size of main body copy and is easily legible) and states what the inactive ingredients that differ are in each brand.

2.4 Considerations for audio/video presentations

Video:

The explanatory statement on the data source may be included on a title/divider screen prior to the presentation of

results instead of on every screen where the data is presented

• A closing statement similar to “The presentation of data based on a different formulation is now concluded” should be included to indicate the end of the presentation

Audio:

• – The icon and explanatory statement should be included in the audio. The icon can be read as “Attention”. A single tone may be included prior to the reading of the explanatory statement to provide a break from the regular background noise or pace of audio, thus alerting the listener to pay attention to the audio that immediately follows the tone. (The intention of this tone is to help break up the audio, in a similar way that a visual break would be created in a layout).

NEW - December 2025 - Post-hoc in rare diseases

3. HOW TO FORMAT PRESENTATIONS OF POST-HOC ANALYSES AND ENDPOINTS THAT HAVE NOT BEEN VALIDATED IN APS FOR TREATMENTS OF RARE DISEASES

The study may be a published and peer-reviewed randomized controlled trial (RCT) or real-world evidence/data (RWE/D). The sponsor should provide confirmation from their Medical/Regulatory Affairs (or equivalent) that the product is used to treat a condition that is considered to be a rare disease in either Europe and/or the United States (please also see the Government of Canada document). 

Post-hoc analyses may relate to an endpoint or a subgroup. Endpoints that have not been validated should be related to a predefined, validated endpoint in the study. 

The following caveats apply: 

• The predefined primary endpoint must be statistically significant 
• The findings for the most relevant predefined, validated endpoints from the study should be presented prominently before the post-hoc analysis or non-validated endpoint; the post-hoc analysis or non-validated endpoint should be presented as secondary information 
• Statistics for comparisons should be available; these should be clearly labelled as “descriptive” or “exploratory” in the data presentation 
• Overly selective presentations of endpoints, either predefined or post-hoc or non-validated, favouring the sponsor’s product will not be accepted 

Additional disclosures relating to contradictory data from other studies: 

• Where a published study with contradictory statistical inference for a comparison is known to exist, the presentation should disclose that fact in body copy of the APS. If this contradictory data is uncovered after creation of the APS, that APS shall be updated with the disclosure accordingly. Alternatively, the sponsor has the option of removing the presentation from the APS. 
• Where the contradictory data is based on a predefined analysis from a published and peer-reviewed, well-controlled RCT, the contradictory data should be presented prominently for balance (so as to avoid an overly selective presentation of data). The studies must appear as separate and distinct presentations so as not to appear to be a cross-study comparison. The study parameters for the contradictory study must not draw a direct comparison to the study parameters of the sponsor’s study. 
• Where the contradictory data comes from a post-hoc analysis from published and peer-reviewed, well-controlled RCT, RWE or meta-analysis, it is sufficient to include a disclosure statement indicating the existence of the contradictory study with a cross-reference to the citation list item identifying the reference. However, the sponsor is welcome to exceed this minimum disclosure standard. 

The presentation is informational and claim neutral. The data is not used as the basis for EITHER overt claims of benefit OR creative imagery. 

Three key elements required in a data presentation based on evidence that does not meet the PAAB’s standards for marketing benefit claims: 

• The presentation is boxed (i.e., grey shading or, for faxes, a black outline) 
• The presentation begins with an icon and an explanatory statement on the data source 
• The presentation discloses key study limitations (when applicable) 

Repetition of the data requires repetition of the icon, explanatory statement and disclosure of key study limitations. This sort of data presentation does not lend itself well to a summary page since it cannot be reduced into a concise/summary format. 

These presentation standards are not required for data presentations that are exclusively based on content from the TMA. This applies EVEN if they conflict with other study findings, and/or they don’t pertain to the specific product promoted in the APS. 

3.1 The icon 

The icon should be presented prominently at the top of the presentation. CLICK HERE for Attention Icon Formatting Guidelines. The alt tag for the icon is “Attention”. 

3.2 The explanatory statement on the data source 

The statement should be presented prominently at the top of the presentation. Examples of an explanatory statement are: 

• “The data that follows is from a post-hoc analysis. Data relating to this analysis should be interpreted cautiously as the study was not designed a priori to evaluate this outcome.” 
• “The content that follows relates to an endpoint that has not been validated. Data relating to this analysis should be interpreted cautiously as the clinical relevance and reliability of the endpoint have not been independently established”. 

If the post-hoc analysis is from RWE/D and additional analyses (that are not post-hoc) are also presented, the explanatory statement required for RWE should be expanded to identify and label the post-hoc analysis as such (e.g., “…The presentation on Endpoint X is from a post-hoc analysis. Data relating to this analysis should be interpreted cautiously as the study was not designed a priori to evaluate this outcome”) AND the subsequent data presentation should be clearly and prominently labelled as a post-hoc analysis. This is in addition to the requirements listed in the Guidance on Real-World Evidence/Data. 

Similarly, if the endpoint that has not been validated is from RWE/D and additional validated endpoints are also presented, the explanatory statement required for RWE should be expanded to identify and label the endpoint that has not been validated as such (e.g., “…Endpoint X has not been validated. Data relating to this analysis should be interpreted cautiously as the clinical relevance and reliability of the endpoint have not been independently established”) AND the subsequent data presentation should be clearly and prominently labelled as relating to an endpoint that has not been validated. This is in addition to the requirements listed in the Guidance on Real-World Evidence/Data 

3.3 Disclosure of key study limitations 

The copy “Key Study Limitations” should appear as body copy, bolded and underlined (i.e., at least 75% of font size of main body copy and is easily legible). 

3.4 Considerations for audio/video presentations 

Video: 

• The explanatory statement on the data source may be included on a title/divider screen prior to the presentation of results instead of on every screen where the data is presented 
• A closing statement similar to “The presentation of the post-hoc analysis [and/or “an endpoint that has not been validated”] is now concluded” should be included to indicate the end of the presentation 

Audio: 

• The icon and explanatory statement should be included in the audio. The icon can be read as “Attention”. A single tone may be included prior to the reading of the explanatory statement to provide a break from the regular background noise or pace of audio, thus alerting the listener to pay attention to the audio that immediately follows the tone. (The intention of this tone is to help break up the audio, in a similar way that a visual break would be created in a layout).