Understanding And Navigating Changes To EU Clinical Trial Regulations

By Caroline Kelly, Senior Manager, Consulting,

A major change to clinical trial regulations (CTR) in the European Union (EU) will be implemented in early 2022. A significant regulatory revision will go into effect as the Clinical Trial Regulation (CTR) No. 536/2014 EU will become the new standard by which clinical trials in the EU must be conducted. While this change is designed to simplify the clinical trial process and make drug development more efficient, it also creates questions for sponsors on how best to move forward. Following are some insights into the new regulation and guidance for navigating the evolved regulatory landscape.