'Mandate, objectives and rules of procedure of the Scientific advice working party (SAWP)' on EMA website might be interesting to read.
on page 5 of the above: "28. The SAWP shall not be responsible for pre-assessment of data that will be used to support future marketing authorisation applications."
Does this mean they don't approve the data from the suggested trial? or that can they can pre-assess it from existing marketing authorisation applications?
Would CHMP members who are requesting the additional data necessarily be made part of the SAWP (subject to availability)?? So they could effectively sign off that it meets their needs before the trial is run, rather than just be the opinion of a committee. Wouldn't that be the whole point of it and the role of the SAWP chairperson?(ie, to give the best possible advice)
TIS Price at posting:
10.5¢ Sentiment: Hold Disclosure: Held
