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New Clinical Trial Regulation

Mid April 2014, the European Counsil approved a new Clinical Trial Regulation with an overwhelming majority. This new Regulation will replace the current European Directive, 2001/20/EC, and is expected to be fully implemented in the European Union in 2016. The major changes within this new Regulation are:

– Increasing transparancy of conducted clinical trials: A summary of the results of all clinical trials perfomed in the European Union must be made public within a year after the end of the clinical trial.

– Simplifying the approval process for conducting clinical trials: It is not necessary to submit seperate applications for conducting a clinical trial in all concerned member states. One single applications will be made in the future through an European portal site which will be applicable in all concerned member states. This European portal site will be created by EMA and is expected to be operational by the end of 2015. Furthermore, the current approval system in which a double approval is necessary of an ethical commission and also the competent authority will be replaced by one single approval for each concerned member state. To reduce inconsistent approval timelines within each member state, the new Regulation provide a fixed approval timeline of 60 calendar days in which ethical committees and competent authorities can reach a joined decision. If no decision is reached, the application is automatically approved.

– Joint evaluation of multinational clinical trials: The scientific results of a clinical trial will be assessed by one member state and is reported to all concerned member states. The report can be commented by the concerned member states.

With this new legislation, the European Union aims to increase the number of clinical trials performed in the Union with preservation fo the current standards in patient safety and to tackle the deficincies in current legislation.

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