THE European Medicines Agency
(EMA) Management Board last
week agreed on its policy around
publication of clinical trial data
after extensive consultation which
resulted in “many comments”
including that the draft policy
risked research dollars leaving the
European Union (PD 13 Jun).
A set of user-friendly
amendments proposed by EMA
executive director Guido Rasi will
allow the Agency to proactively
publish clinical trial data submitted
as part of marketing authorisation
applications and also give users the
ability to download, save and print
the trial data for academic and noncommercial
research purposes.
The Board is slated to adopt the
policy in mid-July, effective 01 Oct.
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