ARTICLE | Politics & Policy

EMA seeking comments on data transparency

January 21, 2015 8:00 AM UTC

EMA is seeking comments on its draft proposal for how to implement transparency rules set forth in the European Clinical Trial Regulation No. 536/2014, which establishes a new clinical trial portal and database for the submission and maintenance of clinical trial applications and authorizations within the EU.

The draft specifies the types of information that are to be made public for all registered clinical trials and gives a timeline for posting results that is no later than 12 months after a trial's completion or 30 days after an MAA has been approved or withdrawn. ...