Forum

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. [image: 1764622185134-1ee36e59-cd45-4046-8e87-b8bb3633a425-image.png] 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 @mhouzer The difference between the Standard 4-day initial review of RMTs and submitting as an ARO-4 is that the subsequent revision turnaround time will be an expedited 2-days rather than the standard 3-days. If you anticipate needing a few rounds of back and forth, this can be a good option to get to your final letter more quickly.

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

Lets start with a quick registration video.

This one is tough to answer in a general forum since there are a lot of considerations. First and foremost, the indication is the limitations for the Terms of Market Authorization and therefore sets the context of messaging within advertising. Code section 2.10 applies regardless of perception that terminology has changed. Next, this is a great opportunity for PAAB to remind clients that we do accept endpoints and terminology not listed in the TMA. What we look for is “consistency with the TMA”. Let’s look at a few examples of where it would not be acceptable. If the “new terminology” appears to expand the scope of the indication into a broader population than what is outlined in the TMA. If the “current medical practices” contradict the TMA, such as “use first line” when the TMA states “after failure on class Y”. The studies based on “newer disease terminology” result in the patient populations or outcomes being broader than those outlined in the Product Monograph. If a more specific assessment would provide more value, we invite you to submit for an opinion. You may also reach out to admin to set up a short billable consult meeting that would allow discussion of the specific example (more details to come about this service)

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.

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 ...".