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Hi @Danielle

Section 1.1.4 Endpoints/ Outcomes of the Guidance on Real-World Evidence states “Endpoints/Outcomes must be “consistent with” (though not necessarily “the same as”) those in the TMA. Regardless of whether the evidentiary basis for the presentation is RWE/RWD or an RCT, endpoints are not generally limited to those explicitly included within the TMA. Though the approach for RWE/RWD mirrors that for RCTs in this respect, the following examples are intended to clarify questions received during the consultation process.” You can review the examples in the linked document. Assessment of “consistent with” is made in the context of the combination of the endpoint, TMA and the therapeutic area. The submitter should provide authoritative support within the submission, to support that the endpoint is consistent or similar to those in the TMA and that it is a recognized endpoint within the therapeutic area.

Hey @mef

Thank you for flagging this. We've discussed the matter with the review team to ensure alignment and are updating both internal and external guidance documents for clarity. In most cases, study design footnotes may appear outside the box.

Good Morning @dmauri

This is a specific review question. Please submit the guidelines and proposed product claims. This can be done in a full submission or an opinion if you’d like further clarification prior to building out tools.

Hey @Username
“Schedule 2” is a bit broad. There are many factors and combinations to consider. Could you provide the product or therapeutic class, or Federal drug schedule (see link) to help narrow down the response. Alternatively, if you’re not comfortable sharing in a public space, you can email review@paab.

Hello @Jennifer-Thomson
It sounds like this would fall under a PILOT: Administrative Guideline for the Review of Pre-NOC Advertising Submissions. We’d get the file to “no further comments” pending review of the layout (video) post NOC. Please reach out to admin to discuss the specifics so that we can ensure we’re understanding the request and facilitating the best possible pathway to approval.

Hey @ALee
The same approach of “where applicable” should be applied to the RAMQ coverage as well. The intent of the inclusion is to ensure that the user is clear about the criteria for coverage as outlined by RAMQ. If the definitions and notes clarify or set the limitations/context for interpretation, they should be included.

Hello @manufacturer @agency

Process flow is a business decision. PAAB has adjusted its requirements for Medical/Regulatory sign-off to respect this fact.

What's changing?
PAAB will no longer require med/reg review to occur prior to initial PAAB submission. Upon submitting, if you have opted not to complete Medical/Regulatory review prior to PAAB review, please click "Not Yet" on the submission form. If Medical/Regulatory review was completed, you will continue to have the option to confirm this and provide the Manufacturer Medical/Regulatory contact.

Click here to more about why, new form requirements, and what this means for the review process.

Question? Post below and we'll get back to you.
Thanks
PAAB

Hey @ALee
Not at this time based on PAAB code section 3.1.2 but something we can keep on a list to explore in the future.

Good morning, @Username

Comparative data remains subject to the guidance for evidentiary basis to support comparative claims. As noted above, consideration may apply when the study can be demonstrated to be the basis for approval of the biosimilar. A study that is NOT part of the basis for approval and completed post approval, should meet the standards for high quality evidence (i.e. pre-defined statistically significance endpoints).

Good morning, @copycallosum

In theory, this sounds like an acceptable activity.

Hey @adelaidebaker

1. Yes.
2. Experience claims should not be positioned in a manner which suggests significance to the listing or vise versa. It cannot be stated or inferred that the experience is linked to coverage or that coverage is due to the experience.
3. Patient information should be informational and not promotional. The copy “Now covered on ODB” would be considered promotional. For acceptable communications around formulary coverage, see Guidance on branded patient information section 1.3 Formulary Statements.

Hey @mimi77

Yes. It would be considered discussion of drug therapy or content relating to drug therapy.

Hello @mimi77

During the review, you’d want to make the reviewer aware of the intended link. They will advise if it can be linked based on the content in the PAAB-exempt piece and the unbranded disease-state piece undergoing review.

Hey @ALee

Let’s ensure we’re talking about the same thing when we say “abstract”. When we refer to “abstracts” in the response above, we’re speaking to acceptable abstracts (the published abstract from a published peer-reviewed study that meets the standards of the Code).

This is in contrast to ‘abstracts’ per Code section 3.1.2ii:
“Please note that abstracts presented at conferences and/or in journal supplements (such as study design and results analyses) that have not been subject to independent review are generally regarded as not having sufficient evidence to support claims and may not be used as reference in APS.”

The review would require PAAB to see the full published peer-reviewed study and the abstract to ensure the study is acceptable and subsequently, the link to the abstract is acceptable.

Hello @adelaidebaker

As a general principle, the clinical decision to prescribe or switch should be made based on clinical considerations. Patient preference can be a part of a patient profile but should not be positioned as the reason to prescribe or switch. Patient preference can be presented as a consideration, without drawing conclusions about clinical actions.
With respect to the specific case presented in the question, the copy in the guidelines and the APS would have to be assessed at the time of submission. We’d caution that “broadly defined” may be problematic and that drawing inference around patient choice such as “difficulty remembering to take pills and therefore might prefer injections” would require statistically significant evidence from a published high quality source.

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).