Agreement by the European institutions on the text of a new EU Clinical Trial Regulation
After detailed negotiations, the Committee of Permanent Representatives (COREPER I) the Member States today (December 20) endorsed the agreement reached by the Lithuanian EU Council Presidency and the European Parliament on the Proposal for a Regulation on Clinical trials on medicinal products for human use (and repealing Directive 2001/20/EC).
It now looks likely that this will be adopted in early 2014. It is estimated to come into force two years after the adoption date.
Welcomed by EFPIA
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