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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 or promotional material before its 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. The applicants submitting their Advertising/Promotion Systems (APS) through an ARO will receive a review response by the PAAB within two (02), four (04), seven (07), or ten (10) days, respectively.
New features included in the AROs are:
- Modular submissions
Such submissions allow the manufacturers to build a database or a module library and will be effective from July 2022. PAAB will evaluate these databases to ensure the promotional material is accurate and not misinterpreted. After reviewing every submission periodically, the database will act as a backup for the future, avoiding frequent resubmissions for approval. - 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.
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.
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 to avoid resubmissions and skyrocketing review costs by not-for-profit organizations and advisory boards. At Freyr, we assist pharmaceutical companies to decrease the time-to-market by providing add promo material review with industry-leading turn-around-time at competitive pricing. Reach out to us today.
