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Hey @Maryssa

The initial question related to self-directed digital advertising on an HCP website. The Q&A 199 language you referenced applies specifically to rep-directed materials and should not be relied upon for self-directed digital ads.

For self-directed digital ads, we suggest reviewing the principles presented in guidance on fair balance and web-link destination examples (search “study parameters”).

Required study parameters may be presented either within the same ad unit (including in a clearly labelled scrollable section immediately below the ad) or via a direct web-link destination, provided that:
• it is clear on the face of the ad where the study design is located,
• it is clear how to access the study design
• access does not require additional effort beyond a single click or scrolling (i.e. the content is accessed without any barriers)
Please note that where specific elements from the study parameters are required on the face of the ad (e.g., dose), those elements would not be acceptable solely as a web-link destination or scrollable section.

Happy New Year @dmauri

This appears to be a specific question about a specific project and therefore would not qualify as a general question.
As a general answer to a general question, we would advise that you should consider linkage principles and assess if linking to unacceptable content is occurring. By having the Canadian page as a subdirectory of the US site it looks like a link is being created. If you’d like to have an interactive discussion, please consider PAAB’s new short-call service which is a 20-minute billable session over the phone or web-conference where the specifics of the project can be discussed, and additional guidance can be provided. Please reach out to review@paab.ca to discuss options.

Dear @Manufacturer @Agency

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

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.

Hey @Maryssa

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

Happy Monday @charlton

No. This would not be an acceptable comparison. See Q&A 674 and Can we present a side-by-side comparison of the trial design of our product's pivotal trial vs. the trial design of our competitor?.

Hello @Maryssa

Q&A 501 is exactly the one we would have pointed to @dmauri . However, the copy "Now authorized" alone is incomplete (authorized how? for what?) it should be restricted to "Authorized for use in..." or "Authorized for sale in ...".

Happy Monday @Manufacturer @Agency

Change is in the air for PAAB’s Accelerated Review Options (AROs)!

A client favourite, the ARO service has built a strong track record of expediting approval for the types of submissions that fall within its scope. This success has motivated us to explore creative ways to expand its availability, and make it even better.

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 including a revised fee structure that will take effect December 8th, 2025.

New: ARO availability broadened significantly

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

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

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

Hello @support
If we are to assume that this is in an HCP gated space, we would advise that claims should not directly/indirectly highlight things like the shortage of competitor(s). Instead, the message may focus on reminding the audience about the sponsor’s product and availability in the market. You correctly identified that it would not be exempt. The piece would be subject to the Code and would require lowest level fair balance if restricted to a product availability message.

Hey @Username

In the consumer space, a standalone message such as “Get Brand X” can be acceptable when used strictly as a DTC reminder ad. However, a URL is rarely a standalone message. Its acceptability depends on the entire ecosystem around it, including:
• the content that drives traffic to the URL
• the content on the landing page
• any content linked after the landing page
If those connections change the overall impression or strengthen the implied message beyond a reminder ad, the URL may no longer be acceptable.
Because of this, it’s essential to share all current and planned linked content during the review process. With the full context, the reviewer can guide you on whether the URL maintains an appropriate attitude of caution and meets PAAB requirements.
It’s also important that any new materials that will link to this URL clearly communicate that a linkage will occur, so PAAB can assess the combined effect.

Good Morning @MondayMover

In general, what people do is upload the “track changes” version between the original and updated PM. When there are multiple version updates, they provide (upload) the sequential PM track changes PDFs. You do not need to annotate each version of the TMA to the APS, only the most recent PM. In the case described, it sounds like there would be no annotations within the PM as no copy is referenced back to it. If that is the case, it’s likely sufficient to upload the most recent clean PM with an explanation of why the new TMA with annotated changes may not be necessary. Please feel free to reach out to admin for support during the submission process.

Hey @kshulist

1. Branded APS can present mortality/prognosis in general terms in the context of disease burden in an un-emphasized manner when there is no product data for mortality/survival, i.e. it is presented among a broad discussion of burdens including those that they have supporting product data for and there is a prominent disclosure included, indicating what the product has not demonstrated an effect in mortality/survival. Please see our disease burden document for additional information.
2. This is generally correct. Please see answer to question 1 above.
3. Yes, section 3 of the disease burden document provides the required references to establish the burden, e.g. authoritative consensus guidelines.

Hello @Manufacturer and @Agency ,

The PAAB remains committed to supporting our stakeholders with trusted, robust guidance that promotes excellence and compliance in healthcare communications. As part of this commitment, we are introducing an important update to how our informational and reference resources are accessed. Certain PAAB materials will now be available through a secure, gated platform. Users will be able to log in using their eFiles credentials, or create a new user account with their work email, to view or download select documents.

We’d like to share the reasons behind this update:

• Protecting intellectual property:
  PAAB’s materials reflect years of accumulated expertise, analysis, and refinement. Gated access helps distinguish PAAB intellectual property from other content.

• Preventing misuse and misinformation:
  PAAB resources are intended as guiding principles and tools but are not exhaustive contextual presentations of the application of the PAAB Code. Gated access helps reduce the risk of misinterpretation or inappropriate reuse, particularly as AI tools become more prevalent.

• Ensuring content accuracy and integrity:
  By managing access through a verified platform, we can better ensure that users are consulting the most current and accurate versions of our documents, minimizing the risk of outdated or misleading interpretations.

• Enhancing user experience:
  Over time, the platform will allow us to improve how resources are delivered, helping you access the most relevant information more efficiently.

Our goal is not to restrict access, but to safeguard the quality, credibility, and responsible use of the information PAAB provides.
This change supports our shared mission of fostering trustworthy communication in healthcare marketing and advertising.

We appreciate your understanding and partnership as we take this proactive step forward.

PAAB Team

Hello @Username

Is the product dual schedule or only “ethical”? Is it for the treatment of a schedule A disease?

One would need to consider schedule A and dual scheduling to establish which DTC regs are applicable (and consequently the degree to which they differ from HCP regs). If we assume the product is not dual scheduled and its use is not on schedule A, it is likely that the same imagery and heading can be used. However, there are instances where that is not the case because the HCP looks at the ad from a different vantage point as the general public (I.e. the same message can convey different/additional meaning for the HCP). Also, the HCP piece may contain different content that impacts the context in which the image and heading is interpreted.

One way to make sure the same image can be used is to submit an opinion to PAAB for the DTC along with the HCP piece.

Happy Almost Friday @Manufacturer and @Agency

Your PAAB Q3 Forum Review is now live!

Some of the things that you might want to check out:

• AI assisted submission process - Call for volunteers
• ARO expansion
• Client Messenger Service
• Creative Imagery Document Posted
• Coming soon: RWE formatting update, new service offerings, and more...

As always, thoughts and feedback are welcome below .
Thank you
PAAB

Good afternoon @Username

As previously noted in the question "Comparative therapeutic claims of schedule 2 products in DTC setting", the term “Schedule 2” is quite broad. Could you please clarify by specifying the federal drug schedule?

With respect to your question about whether there is a “clear regulation that would forbid DTC and HCP from having the same visual or headline,” this depends on how “clear” is interpreted. There is no direct statement in the Food and Drugs Act that explicitly addresses this scenario. However, the principles governing advertising regulations are outlined across several regulatory and guidance documents.

The nature of the claims and visuals would influence how such a case is assessed. Additionally, the idea that materials could be independently reviewed and approved by each “respective agency” may present challenges, as this would assume both agencies are aware of each other’s submissions, which is not always the case.

We would therefore recommend submitting the materials for an opinion to ensure clarity and alignment with the applicable standards.

Hey @charlton

Great question. You can provide a link to the HCP and to the patient. On the landing page, you can present the product name and the DIN login or HCP verification login. The site cannot link back to the parent company site or any site containing the PM. There should be no logo or promotional content on the pre-gate landing page. You also cannot use Search Engine Marketing (SEM).

Good Afternoon @Manufacturer and @Agency

Another quarter in the books. The PAAB Quarterly Tag and CEI Reports have been updated to contain data for Q3. See the Tag Report here and the CEI Report here.

Please share with colleagues and promote awareness that PAAB publishes these results quarterly. Remember that tags and the Customer Experience Index (CEI) are the most effective way to help PAAB track trends and improve experiences.

If there's more you'd like to know in Q4, let us know in the comments below. Hope you're enjoying the snow.

Thank you
PAAB

Hi @HollyMed

While this activity would be acceptable, the RMM/RMT requires PAAB review. MSLs are representatives of a company that has a vested interest in the health product. Having an MSL detail to an RMT renders the activity subject to advertising regulations. This amplification context differs from a reactive interaction, largely driven by the HCP, in which the MSL responds to an HCP’s one-on-one inquiries. As a reminder, Health Canada’s policy document “The Distinction Between Advertising and Other Activities” emphasizes that the determination of “advertising” versus “non-advertising/promotion” depends on the nature of the activity itself rather than on job titles assigned by the sponsor.

Regarding the second part, data presentations are not automatically compliant with advertising regulations simply because they pertain to risk. Compliance depends on multiple factors including (but not limited to) completeness, significance, context, and selectivity. Even data presented in a neutral tone can mislead if not balanced or contextualized appropriately. While the activity itself can be permissible, the slides require PAAB preclearance per the PAAB Code.

Hey @kshulist

Correct. You cannot speak to unmet need in a branded context.
Even if the drug is the first treatment for a certain condition, discussing “unmet need” suggests that the product addresses that need in an absolute manner. There are still ways to convey treatments where no options were previously available without stating “ need”. PAAB may be able to assist with the direction of messaging. Please reach out for additional assistance in a forum that allows for more specifics to be shared.