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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.
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)
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.
Hey @mimi77
While we don’t provide reviews of the Forum, in general terms the claim should reflect the nature of the update. From our understanding of the description, this would be authorization in a new population (pediatrics) and not a net new indication. As such, claims should reflect “Now authorized for use in pediatric patients for x” or something similar.
Hello @msargeant
Apologies for not seeing this question sooner. Per 3.1.1, post-hoc analysis are generally not considered acceptable evidence at this time. The circumstance in which post-hoc analyses would be considered acceptable is outlined in the statement that follows that copy which states “Data included in the TMA may be acceptable”. HTH.
Hey @HollyMed
Yes, per the copy "In the scenario described above where guidelines lower in the aforementioned hierarchy are being used over the available US guidelines, evidence must be provided to support that these guidelines are a true reflection of Canadian practice". Note that there may be instances where we ask for more information about US guidelines. This is extremely rare and the rationale is disclosed during the review process. If you find yourself in this rare instance, please reach out to the reviewer for clarification.
@Jennifer_CM
Example 3 appears to be about the product monograph web link destination. The original question above is about linking middle level fair balance to highest level fair balance. Linking middle level fair balance to highest requires that it’s within the same tool or directly attached. A print journal ad is not the same medium as a URL link (web based) and therefore would not be acceptable.
Hey @ALee
“Indirect link to a general formulary/Provincial homepage” is the same as “full formulary list of a province”. As per the response above, this would not be considered exempt.
Hi tk2022
Please see our more recent “Guidance on Real World Evidence/Data” for criteria and direction on the presentation of RWE in advertising to health care professionals. Please also see our "Guidance on the use of the Attention Icon" regarding unblinded data.
Claims based on acceptable, authoritative consensus guidelines do not need to be verbatim from the reference. However, it must capture the recommendation accurately and within context. It must not impart a new or different meaning than the guidelines.
A sale representative may leave a physician a full, unedited copy of a published, authoritative consensus guideline for a given condition. Please see the linked document on “What constitutes current medical opinion and practice?”. Depending on the nature of the visit, please also be reminded that distribution of material by a sales representative may constitute an act of advertising and should adhere to the advertising regulations, e.g. product specific guidelines on off label use would be a violation of the regulations.
Hello @dmauri
PAAB will generally consider alternate cut offs from the TMA if it does not appear to be minimizing the risks of the product. The alternate cut-offs should not remove pertinent ADRs/safety information that would otherwise be important to the product and within the therapeutic landscape. The TMA should also not have other safety considerations that would preclude the higher percentage cutoff.
Good Morning @Jennifer_CM
Linking out to an unedited acceptable reprint would not render the email subject to highest level fair balance. The level of fair balance would be assessed based on the content of the email body in combination with the linked content. Therefore, it’s likely that the level of fair balance could be lowest level if the body copy does not prompt middle or highest itself as per the PAAB Guidance on Base Fair Balance Level Selection and Placement (HCP Advertising).
Hey @Supriya
This appears to be a specific question about a specific piece. Copy around “new product availability” is broadly open to interpretation. PAAB would also need to see the third-party program site to assess the combination of all messaging within the piece and the linked content. We suggest submitting for an opinion.
Hey @Pauvian
Advertising in a consumer space must meet the consumer regulations (i.e. does not exceed name, price, quantity for prescription (Rx) products or treatments for schedule A diseases). We would advise against including the DIN as this is a standard mechanism for gating patient information. Including the DIN would require assessment of all patient sites for the product to ensure this list is not promoting the password to the general public.
Note that the question is in response to a “list”. The website appears to contain additional elements (such as pictures) which may render the site in non-compliance. We’d recommend submitting for an opinion in order to fully assess the complexities of the proposed activity.
Hey @Supriya
This appears to be a specific question about a specific piece. The piece should be submitted for assessment. The forum is for general questions. As an example, a general question here might be “Is the inclusion of an indication statement required in materials directed exclusively to healthcare professionals, where no therapeutic or pharmacologic claims are presented”. The answer to this question would be, that the indication is not required when there are no marketing benefit or therapeutic claims (see Marketing benefit claims: What are they and what level of support do they require?).
