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We have enhanced the Ask PAAB section to make it more user-friendly due to the growing number of questions. You can now select a category of interest from the drop down menu above to view existing question and answers or you can also do a search for questions that have been submitted to Ask PAAB since the beginning.

Most Recent Questions and Answers
600
Regarding Code s3.1.1, does PAAB distinguish between different types of "pooled data"? For example a post-hoc pooled analyses of unrelated trials (low evidence), vs. a pre-specified pooled analyses of replicate trials (higher evidence)? Such pre-specified pooled analyses are commonly used in registration trials for certain therapeutic categories, and therefore interpretation of s3.1.1 could potentially be biased.
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599
Suppose a Product Monograph contains pooled data presentations (demographics, efficacy, safety, etc), but the individual data sets are from separately conducted and published studies, with no planned pooling. Would it be acceptable to report the individual data in APS, or would PAAB require it to remain pooled (and subject to the associated limitations). Traditionally pooled data are not regarded as high-level evidence, but in some cases Health Canada has requested the pooling of data, not the study design itself.
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598

Seeking some clarification on the response to Question #273. Can you confirm that the answer "It may be exempt if all the treatments are balanced" applies only if the piece in question is consumer-directed? We're assuming that HCP-directed exempt material (s6.6) can never mention treatments (balanced or not), otherwise it would be considered Editorial (s7.5).

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597

We have Data on File that was part of an NDS, but was not explicitly included in the TMA. We feel Health Canada has 'accepted' this DOF, by virtue of related label negotiations and direct correspondence. What type of proof would PAAB require to consider use of the DOF in APS: Sponsor Regulatory confirmation, Sponsor correspondence with Health Canada, contacting Health Canada directly on behalf of the Sponsor, etc?

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596

A disease-state piece includes mention of treatments in a balanced manner. It is distributed to consumers as a Consumer Brochure and technically exempt. Can this same piece be distributed to HCPs, or would it have to be revised to meet Editorial APS requirements? Does the content and/or level of detail dictate this?

595

Will PAAB approve MOA comparison around selectivity in an unbranded leave behind - content is not from individual TMAs but from recent post-NOC invitro peer reviewed paper?

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594

For non-prescription marketed health products, is it a requirement to include a product's DIN or NPN on an advertisement/promotional piece directed at a healthcare professional?

593

We would like to do an unbranded piece based on treatment guidelines. There are no Canadian treatment guidelines for this disease. Can we use a European guideline (not for a particular country but from a European society (endorsed or recognized by an authoritative medical body)? Can we use two guidelines together, the European and the US guideline? If some of the products are not authorized in the same way in Canada as recommended in the guidelines, should we not mention that use or we should clarify that is not the way that is indicated in Canada? Thank you for your help.

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592

Removed 07/2018


591

HI PAAB, when a drug goes from pre-NOC to NOC, is it possible to use the wording "Now Approved In Canada". Also, if this is marketed to general population, does it need PAAB approval? Thanks

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Deputy Commissioner  

Patrick Massad
Deputy Commissioner

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