By: Gabrielle Bissessar, Senior Health Strategist, Amsi Sivanesanathan, Manager, Health Strategy and Anna Arciszewska, Manager, Health Strategy (dentsu health Canada)
The recent updates to the PAAB submission process may have left you scratching your head, but do not fear, dentsu Health Canada has your back. From Accelerated Review Option (ARO) submissions to module libraries, we have broken it down for you into edible bites!
Disclaimer: Please note that this is our interpretation of the guidance the PAAB has released for their new set of offerings. Please visit PAAB’s website or contact them directly for the official guidance on their submission process.
Let's start off with the basics. The Pharmaceutical Advertising Advisory Board (PAAB) is a Health Canada recognized, not-for-profit organization. They offer a pre-clearance service which ensures that health product advertising is compliant with the standards outlined in the Canadian Code of Advertising Acceptance. Essentially by submitting your creative for PAAB approval, you can feel confident that you are compliant with the standards set out by Health Canada.
The PAAB submission process typically requires several rounds of review, where the first submission was a standard 10-day review, followed by 3-day review periods for subsequent submissions. In a perfect world, a submission consisting of a minimum of two rounds of review would still require around 13 business days. This is without any expressed concerns or negotiation on either side, which is highly uncommon--especially for new products, indications, or claims.
This year (2022) PAAB has released three new submission options which can streamline the pre-clearance review process:
First up is Accelerated Review Option (ARO):
With this option you can pay an additional fee to expedite the review process. Please note that only select materials are eligible for ARO, including time-sensitive announcements (e.g., formulary coverage changes, guideline updates, etc.) or materials with “minor updates”. Click here to see a full list of materials that may be eligible for an accelerated review.
Check out the chart below to discover the different options and timelines:
|Submission Type||1ST Response||Revision Responses|
|Standard||10 days||3 days|
|ARO-10||10 days||2 days|
|ARO-7||7 days||2 days|
|ARO-4||4 days||2 days|
|ARO-2||2 days||2 days|
Next, are Modular Submissions:
This review option allows you to build a set of modules (i.e., blocks of content) which will be reviewed and approved, in turn creating a module library or database. You can then mix and match your pre-approved modules to build your materials. As a result, the review process will not only be much smoother and expedited but also cost-effective since the PAAB will only be assessing the flow of the content. This may be useful for initiatives that include multiple materials leveraging the same content.
And finally…Iterative Submissions:
When creating materials that may be disseminated on various platforms (e.g., eblasts vs. fax blasts, or websites with different layouts such as mobile, tablet, and desktop), iterative submissions may be the option for you! This submission style can be used for campaigns which have similar content but have slight variations to the layout due to platform differences. PAAB reviews the initial submission at full cost but provides a discounted review for every iterative submission.
To better understand the fee structure for these new submission options, PAAB has released a Submission Fee Calculator that may help you out!
With these new submission options, PAAB is providing more flexibility when it comes to budgets and timelines. Should you have any questions, take a look at the full guidance on the PAAB website, watch this video series they put together for a breakdown all of these new changes, or reach out to our team to help you optimize these new offerings directly.