Clinical Trials Regulation Brings Fundamental Change To European Studies

By Craig Morgan, Global Head of Marketing, Oracle Health Sciences

In 2014, the EU adopted a new regulation with the intention of improving the efficiency of the clinical trials process and delivering safe, effective drugs to patients more quickly.

With Regulation (EU) 536/2014, member states and governing agencies aim to reverse a decline in clinical trial applications in Europe by harmonizing the submission process for study applications, speeding assessments and decisions, and improving data transparency for both patients and researchers. The three-year transition to the regulation began January 31, 2022, and as of January 31, 2023, clinical trials applications in member states may only be submitted under the regulation.