Effective February 1, 2024.

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