Good Afternoon @Manufacturer and @Agency
It's crazy to say but we're now just past halfway through 2025!
The PAAB Quarterly Tag and CEI Reports have been updated to contain data for Q2. See the Tag report here and the CEI report here.
The Forum Quarterly Review for Q2 has also been posted here.
If there's more you'd like to know in Q3, let us know in the comments below. Have a wonderful rest of the summer.
Thank you
PAAB
Hi @support
A strictly informational statement about stock such as “Product X 5mg dose now back in stock” could be considered exempt.
The inclusion of the indication statement renders it no longer exempt.
The inclusion of a product photo MAY render it no longer exempt. This piece should likely be submitted for an exempt opinion to assess if the product photo can be used while meeting exempt criteria.
Hi Jennifer,
Thank you for your response!
If we were to include a message about a specific dose of the product that is now back in stock, would this piece still be exempt?
Additionally, would the inclusion of the indication statement or product photo make this no longer exempt?
Looking forward to hearing from you.
Lily
Good morning, @Manufacturer @Agency
PAAB will be performing an upgrade to the eFiles system tonight, July 29th. We will be shutting the eFiles system down from 5pm-midnight to perform the upgrade. Please note that users will not have access to eFiles during this time.
We’re sorry for any inconvenience that this causes.
Thank you
PAAB
Hey @support
A simple availability message such as “Product X is now back in stock” would be considered exempt. To remain exempt it should be limited to an informational message (not linked to therapeutic or promotional messages) about stock. (s1.5D)
Hi PAAB!
Would a message like "X product is now back in stock!" be subjected to PAAB review?
If it is not subjected to PAAB review, what are the conditions that it has to meet?
Thanks in advance!
Lily
Hey @dmauri
Great question. As long as the study publication does not contain information suggesting dosing practices inconsistent with Canadian labelling, the manufacturer’s Medical/Regulatory Affairs department can confirm that the dosing in the jurisdiction where the study was conducted is the same as it is in Canada.
When it comes to “SoC”, per 1.7 of the Guidance on Real-World Evidence/Data, remember that pooled comparisons are not acceptable which would render the second half of the question moot. However, if you are referring to SoC in a single-arm study (per Advisory: RWE Single-Arm Studies of Previously Treated Patients), we would look to ensure that the overwhelming majority of patients were on a product available in Canada/indicated in the same population in Canada. Regarding "SoC", please note the guidance's remarks on representing the marketplace versus exclusions by design. An opinion can be a great mechanism to get specific guidance on an individual study as it allows for assessment of the study design, therapeutic area, and indicated product(s).
Hey @JDilly11
Hard to provide comments without seeing the updated TMA copy. This question is likely better submitted as an opinion so that we can look at the update and the nature of the claims being made in current or proposed future pieces. As a general guiding principle, the assessment is made by looking at the update in combination with the APS copy to ensure it reflects the same context as the TMA. If there is something that would trigger the inclusion, then it will likely have to be added. Whether both data presentations are required will also depend on the APS copy and the finalized TMA copy.
Hello,
The Product Monograph for a drug I work on is being updated. Specifically, there is adverse event information being added from a Dose Regimen study (which doesn't have a placebo arm). This data will be presented separately from the adverse event information from the placebo-controlled studies. My question is: what implications will this have for safety claims in promotional pieces? If we were to make a claim of "demonstrated safety profile", would we necessarily need to include the most common AEs from BOTH the placebo-controlled and Dose Regimen studies?
Hello! We have come across multiple retrospective cohort studies that could potentially be used in APS, thanks to PAAB's Guidance on RWE. One issue that has come up for a couple of these studies is the lack of dosing information, which is required to fulfill 1.1.3 of the RWE Guidance. We believe that it is common for specific dosing information to be omitted from these studies, but think that it is fair to assume that a large majority of the patients would be dosed based on regional labels (e.g., SmPC, US PI). For such studies where dosing information is not available, can we simply cite the regional label?
Another consideration for a couple of these studies is the use of a "SoC" comparator pool, in which of some of the SoC treatments lacka Health Canada-approved indication that aligns with the study. Would this contravene 1.7 of the RWE guidance?
Thank you for your help!
