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Brussels, 20 December 2013
Health Commissioner, Tonio Borg, welcomes agreement on the revision of EU rules on Clinical Trials
"I welcome the agreement reached at COREPER today on the revision of the EU rules on clinical trials. I thank the Lithuanian Presidency for the progress on this important text for people's health and EU competitiveness. The agreement reached today makes the final adoption of this Regulation possible1 before the end of the European Parliament's current term.
Clinical trials are indispensable for developing and improving medicines and ensuring that EU patients can have access to the most innovative and effective treatments, under high safety and ethical standards.
The revised rules will ensure that the EU remains an attractive location for clinical research – which is of vital importance for Europe's competitiveness and innovation capacity.
I welcome that the new rules will take the form of a Regulation, which is directly applicable throughout the European Union.
While the Commission would have hoped for a more ambitious approach in line with its original proposal, the new Regulation introduces some significant measures which will contribute to boost clinical research in Europe, for example:
The political agreement is subject to technical finalisation and formal approval by the co-legislators.