A quarterly review of the eFiles tag report 

Total number of submissions

 Total number of client tags (prior to validation) 

Tag submitting company and manufacturer distribution 

 Therapeutic area distribution

 Total number of tags deemed valid following internal review

Validated tag breakdown

Q1 PAAB action taken:

Two of the valid tags resulted through a misunderstanding. When submissions come in with a single provincial formulary or provincial guideline, it is PAAB’s understanding that distribution is restricted to that province. After all, the fact that brand X is covered in PEI would not appear to be relevant to the medical practice of an HCP in BC. Similarly, specific recommendations from a provincial governing body would only appear to be relevant for communications in that province.   

PAAB will monitor the issue to see whether it persists and whether there exists a need for PAAB to request confirmation of that understanding within files. For the moment, however, we will continue to work with that understanding.

Reasons for not validating a tag:

Selecting the right tag plays a significant role in the approval of a tag. As a hypothetical example, the tag “Ruling perceived to be inconsistent with code guidance” supported by a description similar to stating that confirmation that a source was from an authoritative text be provided in writing has never before been requested, would not align. There are two factors at play here. The first is that there should be some explanation of why the submitter feels this is not aligned with the code. The submitter was directed to Section 3.1 and 3.2 of the code which speak to scientific literature and current Canadian medical opinion and practice. We would need context as to why the request for confirmation of the authority of the source does not align with these code sections. The second issue would be the assumption that because the submitter has not seen the request before, that the request does not have merit. There are many reasons for even the most seasoned agency person to see a comment they’ve not seen before. In this case, note that there are plenty of references that PAAB is already aware are considered authoritative text. Subsequently, we would not ask for confirmation every time. A reviewer might be aware that a reference has already been validated in another file. In this case they would not ask for revalidation. The reviewer may have been able to validate the reference on their own. These are just a few reasons why a comment may not have come up in the past and now is surfacing.  

A reminder that pre-NOC submission response times are at the discretion of PAAB based on workload as products with market authorizations take priority. PAAB will continue to do their best to provide timely reviews.  

Is there more information you would like to know and see in the next quarterly update? Let us know on the Forum.