Navigating the New EU Clinical Trials Regulation Requirements for Clinical Supplies
Summary: On January 31, 2022, European Union (EU) member states became legally required to enforce the Clinical Trials Regulation (CTR) No. 536/201, intended to replace the Clinical Trials Directive (2001/20/EC), which had often been criticized. The purpose of the new regulation is to improve on the process flaws of the directive, but with that comes changes that sponsors conducting trials in the EU must be aware of and plan for accordingly.