The European Union (EU) Clinical Trials Regulation No. 536/201 (CTR) is expected to impact nearly every aspect of clinical research in the EU. While the stated purpose of the new CTR, which replaces Clinical Trials Directive (2001/20/EC), is to streamline the authorization procedure of clinical trials in the EU, sponsors must recognize that the CTR also contains many non-application-related changes affecting current good manufacturing practice in the EU, including changes to labeling, quality technical agreements, and regulatory release.
This article will examine CTR labeling changes and discuss their potential to disrupt traditional clinical supply strategy should sponsors misunderstand or fail to adhere to the new requirements. To adapt, sponsors must act prudently to mitigate their regulatory risk during the ongoing transition period and explore the potential advantages that moving toward a more innovative and flexible clinical supply strategy can achieve.