"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 possible before the end of the European Parliament's current term," says Borg in a statement.
The statement of the Commissioner stresses that 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," says Borg.
According to the Commissioner, the new regulation introduces some significant measures which will contribute to boost clinical research in Europe. For instance, a streamlined application procedure via a single entry point – an EU portal and database, for all clinical trials conducted in Europe; a single authorisation procedure for all clinical trials, allowing a faster and thorough assessment of an application by all Member States concerned, and ensuring one single assessment outcome and authorisation per Member State; improved conditions for conducting multinational clinical trials, which are key for rare and serious diseases; more transparency on the conduct and results of the clinical trial, thanks to a compulsory prior registration on the EU portal, the possibility for the Commission to conduct controls in Member States and third countries to ensure the rules are being properly supervised and enforced and so on.
