Impact Of The Revised EU Clinical Trial Regulation CTR 536/2014: Equipping Sponsors With Knowledge, Tools, And Expertise

By Craig Elliott, General Manager, European Operations and Shirley Rutter, Associate Director, Global Quality Management

On January 31, 2022, the European Medicines Agency (EMA) Clinical Trial Regulation (CTR) 536/2014, came into force with the goal of improving transparency of clinical trials among the public and harmonizing submission processes within the European Union (EU). The Clinical Trial Information System (CTIS) registration portal (EU Portal and Database) is now live and available for use by trial sponsors and their clinical research organization (CRO) partners.

When properly planned the CTR’s single application submission and routing process can potentially speed pharmaceutical development in the EU. However, a slight error in the process can lead to various risks.