Article | January 18, 2022

Understanding And Navigating Changes To EU Clinical Trial Regulations

Source: THREAD

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.  


Get unlimited access to:

Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue. X

Enter your credentials below to log in. Not yet a member of Clinical Leader? Subscribe today.

Subscribe to Clinical Leader X

Please enter your email address and create a password to access the full content, Or log in to your account to continue.


Subscribe to Clinical Leader