Despite the pandemic, the EU Clinical Trial Regulation, which massively changes the logistical and administrative way of running clinical trials in the EU, will be in force very soon. The EMA through its management board issued a statement announcing that the EU portal, through which all the projects of clinical trials for the EU will be lodged, is functional and on track to go live on 31 January 2022, despite of a significant delay compared with the initial date scheduled in the EU Regulation.
If it launches without further delay, it will have taken over seven years since the publication of the EU Clinical Trial Regulation (CTR) back in 2014, to get off the ground. However, the CTR is a good step in the right direction for those undergoing clinical trials across Europe as they will benefit from greater harmonisation across member states.
Together with the submission of a single clinical trial dossier through the EU Portal, the improved assessment process will ensure efficiency of resources for both sponsors and member state sand predictable approval timelines. Unless confidentiality is justified, the information submitted to the EU Portal will be published allowing full transparency of ongoing trials and their results to the public.
Special thanks to associate Alexandra Laure for drafting this update
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