EU Clinical Trial Regulation 2022: Understanding the impact on clinical research in Europe


Eight years after its adoption, the EU Clinical Trial Regulation (CTR) 2022 has come into full application, radically altering the regulatory landscape for conducting clinical trials in EU member states and European Economic Area (EEA) countries. This whitepaper provides insight into the key changes introduced by the regulation and guidance for managing anticipated challenges, focusing specifically on the following considerations:

  • The impact of the new regulation on existing clinical trials
  • The implications for good manufacturing practice (GMP) guidance and the Clinical Trial Application (CTA) process
  • New labelling requirements, the challenges they may pose, and potential solutions
  • The UK’s approach to clinical trial regulation and the impact of the EU CTR changes on Qualified Person (QP) requirements and other legislation