“The new EU Clinical Trials Regulation (EU-CTR), likely to enter into force in 2016, aims to address some of the issues associated with the existing Clinical Trials Directive. The EU-CTR will continue to ensure applications to run clinical trials are assessed to high scientific, technical and ethical standards, as under the Directive.

However, it is hoped that the Regulation will lead to assessments being made with increased efficiency and harmonisation, with a reduced administrative burden, and within stated timelines. This will ultimately contribute to bringing innovative medicines to patients in a timelier manner.”

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