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Commission, Council and European Parliament agree content of new European Union Trials regulation
At the end of December 2013, the European Commission, Council of Ministers (representing European Union (EU) national governments), and the European Parliament reached an agreement as to the terms of a new EU clinical trials regulation, which will replace the current, and much criticised, 2001 Directive on trial authorisation procedures within the EU.
The new regulation is aimed primarily at dealing with criticisms that the 2001 Directive created a more burdensome and bureaucratic environment for conducting clinical trials, with evidence of a reduced number of trials taking place in Europe as a result. The new regulation will therefore:
Reduce the potential for member states to interpret requirements differently, leading to duplication in assessment and authorisation procedures for multinational trials.
Create a single EU portal for trial assessment and authorisation, under the authority of the European Medicines Agency (EMA).
Introduce more proportionate forms of regulatory requirement where a trial is considered …
Competing interests None.
Provenance and peer review Commissioned; internally peer reviewed.