The Impact Of EU 536/2014 Has Yet To Be Realized

By Elvin Thalund, Director, Industry Strategy

In 2014, the European Union enacted the clinical trial regulation EU 536/2014 with the goal of improving the quality of clinical trial material submitted to the European Medicines Agency and making the EU a more attractive destination for clinical trials. The regulation mandates all EU countries’ use of the Clinical Trials Information System (CTIS) to simplify the clinical trial submission process and replaces the Clinical Trial Directive 2001/20/EC in Europe.

To incentivize high-quality submissions, severe time penalties are levied for failed initial or subsequent submissions with penalties starting at three months and increasing by three-month variables—dependent on the severity of the occurrence. One prevalent issue currently causing delays is protocol amendments from non-EU countries.

While the regulation has yet to be fully realized, this author suggests that it will improve efficiency in the clinical trial process, leading to more transparency and patient safety across Europe and globally.