A quarterly review of the eFiles tag report 

Total number of submissions*

QUARTER 1	QUARTER 2	QUARTER 3	QUARTER 4
2304	2467	2147

*Refers to unique eFiles. This number does not account for iterations within each file.

 Total number of client tags (prior to validation) 

QUARTER 1	QUARTER 2	QUARTER 3	QUARTER 4
13	14	19

Tag submitting company and manufacturer distribution 

QUARTER 1	QUARTER 2	QUARTER 3	QUARTER 4
3 & 1	7 & 0	6 & 1

 Therapeutic area distribution

QUARTER 1	QUARTER 2	QUARTER 3	QUARTER 4
4 Immunology 2 Neurology 2 Vaccine 2 Dermatology 1 Gastroinstinal 1 Endocrine and Metabolic 1 Cardiovascular	5 Biologic/ Immunomodulator 4 Gastrointestinal 2 Vaccine 2 Oncology 1 Women's Health 1 Other	6 Pulmonary 4 Infection & Infestation 3 Immunology 2 Obstetrics & Gynaecology 1 Psychiatric 1 Endocrine & Metabolic 1 Oncology 1 Dermatology

 Total number of tags deemed valid following internal review

QUARTER 1	QUARTER 2	QUARTER 3	QUARTER 4
4	5	7

 

Validated tag breakdown

QUARTER 1	QUARTER 2	QUARTER 3	QUARTER 4
2 New issue raised late in the review 1 Inconsistencies with historic approvals for the same brand 1 Particularly helpful comment	3 Particularly helpful comment 1 Consider changing the code guidance 1 Inconsistent with code guidance	2 New issue raised late in the review 2 Particularly helpful comment 1 Inconsistencies with historic approvals for the same brand 1 Requested revision was unclear

Q3 PAAB Action Taken:

Reviewers have been reminded to include a comment or placeholder note on visuals in their responses. This notifies clients that final visuals are required and that additional comments may follow once the copy is revised. This approach helps clients plan effectively and encourages them to consider how the copy may influence the visual context during revisions.

At the last reviewer meeting, reviewers were reminded of the importance of providing precise rationale for requested changes with increased importance being placed on issues that have persisted for more than one round.

Reasons for not validating a tag:

In two instances, there were disagreements regarding formulary presentations. The reviewers directed clients to the relevant guidance documents available on the PAAB website. Please note that formulary presentation requirements are enforced at the request of the formulary bodies, allowing formulary claims to be maintained within advertising.

In one instance, the tag "Late correspondence impacted client" was applied, although all responses were returned on or before their due dates. While a late-stage comment was made (valid tag), the reviewer worked promptly to ensure responses were delivered on or ahead of time, minimizing any potential impact on timelines.

When selecting tags, we kindly encourage clients to carefully choose those that accurately reflect the interaction, as this supports a higher ratio of valid tags. Tags and their descriptions can be found here.

Q2 PAAB Action Taken:

In two instances, the tag was deemed invalid as they were not the appropriate tags. We revised the tags as the clients’ issues were still valid when labelled with an alternative tag. The report reflects the revised tags.

The valid reassigned tags prompted additional training on disease burden for the office to build continuous improvement on consistency and application across reviewers. The second reassigned tag resulted in a change in review practice for inclusion of disclaimers for consumer resources in certain scenarios. This change was applied during the review of that file and will be applied moving forward.

Reasons for not validating a tag:

It’s important to remember to wait until the issue has been resolved to completion. Twice a tag of “Inconsistency perceived because objection was maintained after demonstrating that the same presentation was approved for a different brand”. This was tagged early in the review and upon a clarification letter in one instance and a phone call in the other, it was determined that the wrong backfiles had initially been provided. In another instance the claim of being charged for an extra round of review was inaccurate.

When using tags such as “Ruling perceived to be inconsistent with code/guidance” or “Consider changing the code/guidance”, it can be beneficial for the client to provide details about what they think could be changed and solid rationale for consideration. While it is helpful to point to the comment that prompted the tag, additional context will help PAAB to assess if changes are warranted and better understand the root issue behind the request for consideration.

 

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.  

Confidence in confidentiality As a reminder, client tags trigger internal audits for validation by PAAB’s Director of Pre-clearance Services, Yin Man. Any tags pertaining to Yin are validated by the Commissioner and removed from the report provided to Yin. No Reviewer, Senior Reviewer or Director is EVER aware of tags generated by clients. You can be confident in the confidentiality of the tagging system. For additional reassurance, the tagging system, tag assessments, and documented actions taken will periodically be reviewed by an external auditor. What does PAAB use the tags for? Staff and system performance metrics To identify trends and training opportunities To stay inform on what is going well (best practices) and areas for improvement If you’d like to learn more about the client tagging system, check out the Client Tagging System Advisory. You’ll also find links to useful videos on  tagging a review and tagging phone calls.

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