European Clinical Trial Regulation White Paper
The Clinical Trial Regulation (EU) 536/2014 (CTR) came into effect on January 31, 2022, replacing the previous regulatory framework of the Clinical Trial Directive 2001/20/EC (CTD). This white paper provides an overview of the CTR and its impact on the organizational readiness and operational execution of clinical trials in the European Union (EU) and European Economic Area (EEA) Member States. Discover the main features of the CTR, including the use of the "Regulation" as the legislative instrument, harmonized requirements for applications and reporting, the Clinical Trial Information System (CTIS) as the single entry point for applications, and increased transparency requirements.
Additionally, it explores the operational readiness considerations for stakeholders and suggests topics to address in readiness plans. The paper emphasizes the need to adapt quality management systems, manage confidential information, and comply with transparency and disclosure obligations. It also highlights the importance of CTIS management and user allocation, as well as strategies for handling commercially confidential information and personal data. Overall, this white paper aims to provide a comprehensive understanding of the CTR and help stakeholders prepare for and navigate the new regulatory landscape of clinical trials in the EU/EEA.
