Hi Danika - The RWE Guidance document does mention that Class B opioids and NOC/c products are not in scope, given APS for those products are limited to content from the TMA. However, other controlled drugs may be permitted to utilize RWE.
Also see Q&A 4213
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RWE Usage for Controlled Substance -
Pooled long-term extension dataHi there,
Our regrets for the delay in responding.
The answer to the above original question was provided in general terms based on PAAB code section 3.1.1 which states “…pooled data…are generally regarded as not being evidence to support claims in drug advertising. Data included in the TMA may be acceptable”. Even when the original trials are in the TMA, this does not confer acceptance for their pooled analysis in advertising. Q762 provided the general PAAB position as well but expanded to provide the narrow scope where PAAB has considered pooled data which is dependent on a multitude of factors. Q762 provided the starting point for consideration. As there are varying and specific factors that determine the acceptability of a pre-planned pooled analysis, it is beyond the scope of this forum to address. If there is a pre-planned pooled analysis where the study designs are identical or nearly identical, then we suggest consideration of our opinion service to determine if it may be acceptable for use in advertising.
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Experience and 'First and only' Claims for Controlled SubstanceTo add another example, what about non-clinical claims about dosing like 'once-monthly'?
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Experience and 'First and only' Claims for Controlled SubstanceHello,
Similar to my most recent post, when looking at the marketing of a controlled substance to HCPs, where Health Canada guidance is that all claims must align to/be supported by the TMA, does that apply to exclusivity and experience claims that are non-clinical in nature?
E.g., 'X patient years of experience', 'first and only product in class X'.
Thank you,
Danika -
RWE Usage for Controlled SubstanceHello,
I just wanted to confirm that in alignment with Health Canada's guidance on the advertising of controlled substances to HCPs (re claims required to align to TMA), that the PAAB RWE guidance does not apply here.
Thank you.
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Why can't patient-directed information for prescription drugs be promotional?Hi @QnC
The original question on why can't patient-directed APS for prescription/controlled/targeted drugs be promotional was intended to be addressed in PF Q&A 352 where it was noted that PAAB code section 6 applied to patient directed information and its rationale. The HC Distinction document does not cover patient information, i.e. information to individuals that have already been prescribed the drug. PAAB s6 is applicable to patient information and indicates that “Company controlled or prepared branded patient information is information that contains non-promotional material…All health product information must be consistent with the Terms of Market Authorization (TMA), and should not contain promotional claims.”.
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eFIles Tag and CEI Report - Q4 - 2025Good Morning @Manufacturer and @Agency
The PAAB Quarterly Tag and CEI Reports for 2025 have been updated to contain data for Q4. See the Tag report here and the CEI report here.
This year is PAAB's 50th Anniversary! Stay tuned for treats throughout the year to celebrate this milestone.
We're starting the celebration with:
Client Messenger Service - Free with all ARO in Q1 to celebrate PAAB's 50th Anniversary Learn more here.Have a great weekend
PAAB -
Unbranded fictitious patient profiles following guidelines?Hey @Username
No. Real or fictitious, a manufacturer should not be promoting patient treatment flows that are not reflective of guideline recommendations as per Code section 3.2.
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What constitutes "endorsement"?Hi, I am working in a therapeutic area that currently has no Canadian guidelines. A relevant standard-setting organization, on their website, acknowledges that there are no Canadian guidelines and directs HCPs to the US guidelines. Could this constitute adequate endorsement? Thanks!
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Unbranded fictitious patient profiles following guidelines?Hello PAAB, wondering if a fictitious, unbranded patient would need to follow guidelines in terms of their treatment journey? In real life, HCPs do not always follow guidelines.
i.e., if guidelines recommend Product X as first-line treatment, then Product Y as second-line treatment in refractory patients; could an unbranded patient profile show a patient being initiated on Product Y? Thank you!
