Forum Update: Supporting Community-Led Discussion
The forum was created as a space for shared learning and peer support, and as the community grows, we want to lean more fully into that purpose.
Going forward, PAAB will be taking a more listening-first role in forum discussions. Rather than responding immediately to every question, we’ll be encouraging members to engage with one another, share experiences, and help build collective understanding. PAAB will continue to monitor conversations and will step in to:
- Correct any misunderstandings
- Provide guidance when questions remain unanswered after a few days
- Support discussions where official clarification is needed
Our goal is to foster a collaborative, trusted community where knowledge is shared and strengthened by everyone’s contributions.
Thank you for being part of the conversation.
consistent with TMA
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Does PAAB have a specific guidance document for what it considers as "consistent with the TMA"? If not, do you use the principles from the FDA's CFL guidance?
Hi @rlevit1
The PAAB does not have a single guidance document dedicated specifically to defining “consistent with the TMA”. While many of the principles of the CFL guidance can be considered analogous to PAAB requirements, we suggest referring to and applying only Canada-specific guidance, as ultimately this is the only guidance describing compliant advertising in Canada. Familiar principles such as scientific accuracy (Code Section 2.1), restriction to the approved use and population (s3.1), and appropriate communication of risk-benefit profile (s2.4) are all required by the PAAB code, among others; however, consistency with the TMA as a whole depends on the type of claim and/or evidence posited.
Some resources describing consistency with the TMA relevant to certain contexts include:
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Guidance on Subgroup Analysis (https://www.paab.ca/resources/guidance-on-subgroup-analysis/) , Noninferiority Trials (https://www.paab.ca/resources/guidance-on-noninferiority-trials/), and Secondary Endpoints (https://www.paab.ca/resources/guidance-on-secondary-endpoints/) all describe consistency with the TMA specific to these analyses.
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Guidance on Real-World Evidence/Data (https://www.paab.ca/resources/guidance-on-real-world-evidencedata/). Section 1.1 describes consistency with the TMA with respect to Real-World Evidence/Data; points 1.1.1-1.1.4 can generally be applied to any randomized controlled trial.
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Guidance Regarding Duration of Clinical Trials Used as Reference Support in Advertising (https://www.paab.ca/resources/guidance-regarding-duration-of-clinical-trials-used-as-reference-support-in-advertising/). Some principles in this guidance originate from the CFL guidance.
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Guidance on Advertising for Drugs with Notice of Compliance with Conditions NOCc (https://www.paab.ca/resources/guidance_on_advertising_for_drugs_with_notice_of_compliance_with_conditions_nocc_feb_2018_typofix_docxpdf/), which precludes inclusion of any studies or data not found in the TMA.
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