The EU Clinical Trials Regulation – Experiences from the First 18 Months

changing clinical trial regulation in the EU

Originally posted on Regulatory Focus – a RAPS publication

The new EU Clinical Trials Regulation represents the most significant overhaul of clinical trial requirements in Europe for a generation, and this article describes the insight gained during the months following the implementation of this new regulation. The article reviews the implications for sponsors, describes the experiences and lessons learned of an organization submitting many clinical trial applications during this time, and looks to the near future as the regulation becomes fully established.


The EU Clinical Trials Regulation 536/2014 (EU CTR) was designed with the aim of increasing attractiveness of the EU relative to other regions where performance of clinical trials may be perceived as easier when compared with the many different requirements and timelines applying across different EU countries. By introducing greater harmonization across all EU member states, the EU CTR is designed to arrest the decline in clinical trials performed in the EU that occurred following the implementation of the EU Clinical Trials Directive 2001/20/EC (EU CTD).1 Another key objective of the regulation is a greater degree of transparency in clinical trial–related information, such as documentation pertaining to the study and the status and location of ongoing clinical trials. It is hoped that greater awareness of the information relating to clinical trials will increase patient engagement and facilitate clinical trial participation and collaboration,2 benefiting all stakeholders, including patients, investigators, regulators, and clinical trial sponsors.

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