vitrogro confirmed on meeting agenda

Hi All,

Thought you might be happy to know that Vitrogro is definitely on the agenda at this week's CHMP meeting. Luckily for us they have started (only since December) publishing the meeting agenda's. The January agenda was published overnight and contains this reference to Vitrogro:

"(EMEA/H/D/002831)
(substance to be reviewed) insulin-like growth factor-i (igf
-i) segment),(hard-to-heal wounds,primarily venous leg ulcers)
•
List of Questions: For adoption"

This is found under the heading "5 ANCILLARY MEDICINAL SUBSTANCES IN MEDICAL DEVICES"

The good news is that the EMA are sticking to their timetable!

Also of note is the explanatory note at the bottom of the agenda:
"Ancillary medicinal substances in medical devices
(section 5)
Although the EMA does not regulate medical devices it
can be asked by the relevant authorities (the so-called
Notified Bodies) that are responsible for regulating these devices to give a scientific opinion on a medicinal substance contained in a medical device"

As previously stated I expect an announcement at the end of the week or early next week that a "List of Questions" has been received.

Rev