A quarterly review of the eFiles tag report 

Total number of submissions

 Total number of client tags (prior to validation) 

 Therapeutic area breakdown

 Total number of tags deemed valid following internal review

Validated tag breakdown

Q2 PAAB action taken:

One key issue raised was not being clear on an issue even after a clarifying call. In both instances, the issues had been previously discussed in a past file, so the reviewer did not re-explain. Reviewers have been directed to reiterate the rationale for revisions to facilitate understanding. A trend across the “inconsistent with historical approvals” was that new information had been brought forward since the previous approval. Reviewers have been reminded to clearly convey this to clients when applicable and provide the rationale for why it requires changes to previously approved copy.

A case was identified where a reviewer was inconsistent with the guidance. Discussions with the review team were had on the application of guidance in relation to non-clinical claims.  

Q1 PAAB action taken:

No tags reported in Q1 of 2023. As a reminder, both CEI and Tags are important and serve different but complementary purposes. Additional details can be found in the PAAB resource Client Tagging System Advisory

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