CHMP Agenda

Intersting comparison of medical devices on the December agenda of CHMP.
TIS rates a mention again in terms of a "revised timetable: for adoption". I'm not sure why that is on the agenda as I thought it was the EMA who told TIS that they couldn't submit their answers until January. However, maybe they are just dotting i's and crossing t's?

The other medical device (human serum albumin) has been following the same timetable as VG with a list of questions adopted in January and a list of outstanding issues adopted in September. This time, however, it looks like they have already submitted their responses and it seems they have not hit the mark because a second list of outstanding issues has been submitted for adoption.

This raises 2 issues. 1. Why was TIS asked to delay their submission due to EMA not having time to deal with it while this other company was allowed to submit when they were ready?? 2. Are we benefitted by having the extra time so that we may avoid a second list of outstanding issues or will we face yet another delay in February after we have submitted our responses?? I gues only time will tell in relation to the second question.


Rev