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Jennifer Carroll

To reflect feedback received from healthcare professionals (HCPs) and industry, PAAB is updating the RWE and Attention Icon Formatting Guidance.

The updated formatting standards were co-developed with communication agencies to ensure they meet both regulatory compliance requirements and client needs. This collaborative approach supports implementations that are not only compliant, but also effective in achieving advertising goals.

Additionally, through consultation with stakeholders and experts, PAAB is expanding our approach to advertising for rare diseases, to accommodate presentations from post-hoc studies. Learn more with the updated Attention Icon Guidance.

ATTENTION ICON FORMATTING

The RWE Guidance and Attention Icon Guidance came into effect February 1, 2024 and has allowed for Sponsors to present recent research findings to inform healthcare decision-making in a responsible manner which allows for the limitations of the evidence to be prominently disclosed. These updates are intended to clarify expectations and support consistent application of RWE formatting principles. The updated Guidance is now available on the PAAB website.

The revised approach is aligned with what was presented, discussed, and demonstrated during the PAAB National Workshops.

The updated RWE Formatting Guidance will apply to submissions moving forward. Sponsors are invited to update existing and future materials at their discretion, based on individual business decisions. There is no requirement to revise previously approved pieces (i.e. straight renewals) solely as a result of this formatting update. Any APS undergoing review currently may, but are not required to be updated based on the new formatting; however, all new files will be required to move to the new format effective at the start of Q2, 2026.

Further details and support will continue to be available through existing channels such as General Questions and PAAB Forum.

️ PAAB HOLIDAY HOURS ️
Just a friendly reminder that the PAAB office will close at 12:00pm on Wednesday, December 24th and will reopen at 9:00am on Friday, January 2nd. Please note that the period between closing and reopening is considered non-business time, and emails and phone calls will be returned as soon as possible once we resume operations.

The PAAB staff wishes you a safe and happy holiday season, and we look forward to working with you in the New Year.

PAAB Admin

Maha Dogar

Section 3.1.10 of the code notes "Secondary endpoints should be identified as such and the primary endpoint of the study should be presented in close proximity when warranted." We are unclear about the "when warranted" portion of this statement. Assuming the primary outcome of a study was achieved, would the data/outcomes of this primary endpoint need to be specified if a secondary endpoint is the focus of a promotional tool, in a case when the study is not included in the product monograph? All other parameters of the study, such as patient population, indication, etc., are consistent with the product monograph.

dlew

Is it permissible to include claims re: product cost (after provincial coverage/ financial bridging) in DTC advertising?

Example: "Most people pay $0 for [Drug X]" / "[Drug X] at $O for mosy people after co-pay"

And is so what kind of references would be accepted as suitable proof for these claims

Jennifer Carroll

Hey @Joleen-Santos

This would not qualify as a general question. Please see our website or reach out to info@paab.ca to explore billable options for consultation/written opinions and training.

Joleen Santos

I’m working with an observational time-and-motion study that evaluated process-related parameters (e.g., preparation time, administration time, and time spent in different clinic areas).

Because the study is observational and non-experimental, but does not involve real-world sources such as EMR, claims, registries, or routine practice data, I want to confirm how this type of evidence should be treated in PAAB-regulated materials.

Specifically:

Should this type of time-and-motion study be treated similarly to real-world evidence (RWE) for the purpose of required disclosures, limitations statements, and generalizability notes?

Are there any specific presentation expectations for non-experimental process-measurement studies (e.g., required descriptors of study design, limitations, or other context), distinct from those applied to RWE or retrospective observational research?

I’m not looking to make any clinical-outcome or efficacy/safety claims — just to ensure the correct classification and compliant presentation of this study type.

Jennifer Carroll

Hey @Maryssa

Please see Banner ads, Q&A 199 and Linking mid-level FB to an attachment with high-level (in an email).

danthony

Hello @Manufacturer @Agency

In case you missed it, last week PAAB announced the expansion of eligibility for our Accelerated Review Options (AROs).

This expansion is designed to meet industry needs head-on. We’ve listened to your feedback and invested in processes that make this possible.

The following outlines the key changes to the ARO service.

Historically, ARO was limited to a narrow slice of submission types. As of December 8, 2025 we have flipped the model: ARO is now available for most submissions, with only a few exceptions.

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Note: Previously approved content (appropriately shaded) is not considered new content and would not apply to the new content page limits listed above.

If you'd like your APS assessed for ARO eligibility due to special circumstances (e.g., PAAB has already provided an opinion on the acceptability of a study), please reach out to review@paab.ca for a free assessment

NEW! Messenger functionality is now included with every ARO until March 31, 2026 at no cost

We’ve received very positive feedback on the new messenger feature, and early trends show that it effectively contracts time to approval. In advance of our 50th anniversary, we are offering messenger bundled with any ARO review at no additional cost for the end of Q1, 2026.

To activate messenger, either request it within your initial submission form or email review@paab.ca. This applies to both ongoing and new AROs. Please note that only one package of 5 messages is included as part of this offer.

Note: Messenger remains available at cost for standard (non-ARO) submissions.

ARO is now available for DTC submissions
ARO-2 can now be used for direct-to-consumer (DTC) submissions, provided the submission contains fewer than 10 pages of new content. There are no exclusions applicable to ARO-4.

Notable ARO fee changes
• ARO supplemental page fee increase to reflect the more detailed assessments that are now available to ARO:

ARO-7 and ARO-10: $2/page → $4/page
ARO-2 and ARO-4: $4/page → $8/page

• Removal of automatic upgrades for short ARO submissions: Previously, APS with ≤2 pages of new content received a free level upgrade. This policy created tracking and reporting challenges. Broader ARO availability would further accentuate these challenges. As such, automatic upgrades have been retired.

Please reach out below with any questions.
Thank you
PAAB Team

Maryssa

Hi PAAB team.

Can we include content in a digital ad on an HCP-gated site that requires highest level fair balance (i.e., primary endpoint data) and present the highest level fair balance in a scrollable box that appears at the bottom of the ad?

The scrollable section is manual - it does not automatically scroll through the fair balance for the HCP.

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