ann-ema-180-day-review-questions-received

Manufacturing issues
My understanding is that Vitrogro has been and will be manufactured by Eurogentec Belgium which  has long GMP and comprehensive experience in the manufacture of biogenics. Their manufacturing processes fulfil the requirements of both FDA 21 CFR Part 210 & 211, EU 2003/94/EC and Eudralex Vol 4.
Given that they are based in the EU it is virtually certain that they will have a full understanding of EU manufacturing requirements and that satisfactory answers will be readily forthcoming. The 4 –month delay before a hopefully final and positive ruling is very frustrating  but I keep reminding myself the product is brilliant and has passed all sorts of trials with flying colours.
A plus is that they Eurogentec meet the FDA requirements so manufacturing is much less likely to be an issue down long winding road ahead. Also much of the experience gained from the EU exercise will be valuable for formulating presentations to FDA
A somewhat lesser concern at this stage is the fact that the large batch of Vitrogro already in storage could be fast approaching its use-by date.
Not having a great day what with TIS down and BLT heading south in sympathy!