Total number of client tags (prior to validation)

Tag submitting company and manufacturer distribution

Therapeutic area distribution

Total number of tags deemed valid following internal review

Validated tag breakdown

Q2 PAAB Action Taken:

One valid tag identified a perceived issue with the reviewer’s level of expertise. Upon assessment, it was understandable why the client may have felt this way. The reviewer had described the issues in the copy by citing one Code section, whereas additional relevant sections could have been included to provide a more complete and accurate rationale. During a follow-up call, the reviewer was able to clarify the concerns and guide the client toward a solution.

A second valid tag identified an inconsistency with a previous approval for the same brand. The copy in question had previously been approved within the brand, but it was not consistent with current class-wide expectations or the latest Code guidance. The issue appeared to result from copy that had not been fully updated when the Kaplan-Meier presentation was revised. Reviewers have been reminded to reassess all Kaplan-Meier presentations, including content identified as a direct pick-up, to ensure the most current requirements are applied.

Regarding tags that were not validated:

Ruling perceived to be inconsistent with code guidance: Over the past few quarters, we have observed recurring questions related to several of the more complex areas of the Code, including Kaplan–Meier presentations, long-term extension studies, and real-world data. These topics often require nuanced interpretation, and we encourage anyone developing or reviewing promotional copy to participate in PAAB training to build familiarity with these areas. PAAB will also continue to incorporate additional examples and educational content on these topics through our training programs and guidance materials.

While differences of opinion may arise during the review process, they do not necessarily indicate an inconsistency in the application of the Code. For tags submitted on this basis that were ultimately deemed invalid, follow-up clarification calls helped explain the rationale behind the review comments and resulted in a shared understanding of the applicable Code guidance.

Q1 PAAB Action Taken:

Three of the four valid tags were for “Perceived issue with level of expertise”. In many instances, audits determined that the reviewer’s comments were valid, but the rationale was not communicated effectively. Actions focused on coaching reviewers to provide clearer explanations and to consult senior reviewers when necessary.

Inconsistency with the code guidance was a simple follow up training opportunity for a reviewer in a new space working with a product in a highly unique regulatory category. Training has been provided.

Regarding tags that were not validated:

Consistency with prior approvals (within brand or other brands). Several tags related to perceived inconsistencies between current objections and past approvals. In some cases, the past examples provided by clients were U.S. materials, which are not applicable to Canadian advertising standards. In another case, the product was pre-NOC and did not have past files. It is helpful to show reviewers examples when you believe them to be the same as your proposed content. When there is a difference between the example and presented content, the reviewers have been reminded to explain why previously cited examples are not comparable to the current presentation being discussed (i.e. copy in the TMA, aspects of the layout, context set by different copy etc.).

Incomplete reviews and process misunderstandings. One ticket flagged that a review was perceived as incomplete. The audit revealed that the client submitted only excerpts of the required reference. Clients are reminded that full references should be uploaded. Additionally, there was a perception that the review was incomplete as the reviewer would not provide a review of the full document once presented over the phone. Clients are reminded that clarification calls are to clarify the ask. Additional evidence and references which require detailed review should be resubmitted in writing to allow for proper assessment. Client Messenger is another approach clients could consider when hoping to address individual issues before resubmission.

Thank you to everyone who submitted a tag in Q1. Please note that tags are one of the most effective ways for clients to share constructive feedback and help strengthen our review process regardless of whether they’re valid or invalid. They enable us to recognize best practices, identify opportunities to improve guidances, and ensure greater consistency across the team.

We warmly encourage clients to take a few moments to submit tags in real time — sharing clear, tangible examples helps us continuously improve and enhance the overall experience for everyone involved.

Is there more information you would like to know and see in the next quarterly update? Let us know on the Forum.