PAAB Tag Report 2022

A quarterly review of the eFiles tag report 
Total number of submissions
QUARTER 1 QUARTER 2 QUARTER 3 QUARTER 4
2787 2904
 Total number of client tags (prior to validation) 
QUARTER 1 QUARTER 2 QUARTER 3 QUARTER 4
5 6
 Therapeutic area breakdown
QUARTER 1 QUARTER 2 QUARTER 3 QUARTER 4

 2

  Respiratory

 1

  Oncology

 1

  Hematology (ITP)

 1

Neurological (ADHD)

 1

    Respiratory

1

    Oncology

1

  Biologics/

  Immunomodulator

1

  Blood/Anemia/

  Coagulation

1

  Urology

1

  Diabetes

 

  

  
  

 

  

  
  
  

 Total number of tags deemed valid following internal review
QUARTER 1 QUARTER 2 QUARTER 3 QUARTER 4
2

4

 

Validated tag breakdown
QUARTER 1 QUARTER 2 QUARTER 3 QUARTER 4

2

Particularly helpful discussion or action

 

2

Particularly helpful discussion or action

2

Inconsistencies with historic approvals for the same brand

 

 

 

Q2 PAAB action taken: 

There were 6 tags total in Q2. Two cases of “Inconsistencies with historic approvals” were seen. In both scenarios, the reviewer acknowledged the oversight and advised that corrections will occur moving forward. While oversights are regretful, we do look to rectifying them once identified. We will continue to monitor to ensure that no trends develop.

Q1 PAAB action taken: 

There were 5 tags total in Q1. Two of these 5 were particularly helpful discussions or actions by the reviewer. This is what we like to hear. We’ll continue to keep record of these tags to that we can identify particularly helpful trends. 

Confidence in confidentiality

As a reminder, client tags trigger internal audits for validation by PAAB’s Senior Reviewer 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 or Senior Reviewer 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.

 

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.  

newsletters/Quarter PAAB Tag Q2 2022.pdf

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