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2 min read
The ever-increasing demand for various channels to share information and engage with customers poses numerous challenges in the pharmaceutical industry. Such engagement comes with risks, particularly in the advertising domain. To ensure accurate and good practice, Health Canada regulates the advertising and promotional materials before their dissemination in Canada. The Pharmaceutical Advertising Advisory Board (PAAB) is an organization whose advertising pre-clearance service for healthcare professionals is recognized by Health Canada. The PAAB will be launching four (04) Accelerated Review Options (AROs), in July 2022 in addition to its existing pre-clearance pathway. AROs aim to expedite pre-clearance timelines covering four (04) levels of urgency. Applicants submitting their Advertising/Promotion Systems (APS) through an ARO will receive a review response from the PAAB within two (2), four (4), seven (7), or ten (10) days, respectively.
In today’s environment of increasing regulatory scrutiny and digital commercialization, faster approvals for pharmaceutical promotional materials have become essential. The ARO introduction continues to play a crucial role even in 2025, supporting pharma companies in achieving faster time-to-market and maintaining compliance with Health Canada’s evolving advertising standards.
New features included in the AROs are
Modular submissions
Such submissions enable manufacturers to build a database or module library, which will take effect from July 2022. PAAB will evaluate these databases to ensure the promotional material is accurate and not misinterpreted. After periodically reviewing every submission, the database will serve as a backup for future reference, thereby reducing the need for frequent resubmissions for approval.
This modular approach remains highly relevant as companies adopt structured content and digital asset management systems (DAM/AMS) to streamline regulatory artwork and promotional review workflows.
Iterative submissions
The PAAB incorporates an e-file submission system for applicants submitting several versions of an APS. Doing so will enable applicants to submit different APS iterations in the same docket, allowing manufacturers to track their submissions across various platforms.
With increasing use of omnichannel marketing and multiple content adaptations, iterative submissions help maintain consistency across digital, print, and HCP-targeted assets.
Initial Review Response Time
Applicants wanting to get their promotional material reviewed early can opt for a shorter review response time. Depending on the urgency and budget, they can choose a review response from two (AR0-2), four (ARO-4), or seven (ARO-7) business days.
Applicants opting for ARO-10 will receive an initial review response time set by the standard pathway but can expedite the approval time and review of revisions.
The messenger functionality, an exclusive feature, helps the applicants reduce the rate of resubmissions for approval. This enables the drug manufacturers to gain an insight into the PAAB review decision on crucial segments before resubmission of the documents.
In recent years, the messenger feature has proven especially beneficial for teams managing large promotional portfolios, significantly reducing cycle times and supporting Right-First-Time (RFT) submissions.
APS Types and AROs available at Pilot Launch include
- Time-sensitive announcements
- Information updates approved in prior APS
- Launch materials for products approved via Health Canada’s “Interim Order” or their “Accelerated/Priority Review.”
- Print pieces that are re-purposed to digital media where the criteria for exemption outlined in the PAAB guidance are unmet
- Risk Management Tools (RMTs)
- Patient information APS
Reviewing promotional material is crucial for avoiding resubmissions and skyrocketing review costs for not-for-profit organizations and advisory boards. At Freyr, we assist pharmaceutical companies to decrease the time-to-market by providing additional promotional material review with industry-leading turnaround time at competitive pricing. Reach out to us today.
As regulatory environments evolve, pharmaceutical companies increasingly rely on expert partners to manage promotional compliance, artwork accuracy, and submissions aligned with Health Canada and the PAAB. Freyr continues to support global brands with end-to-end regulatory artwork services, compliant promotional material reviews, and accelerated approval support, ensuring seamless and audit-ready commercialization.
