EU's New Clinical Trial Regulation: What Does It Hold For Sponsors And Sites?

The Clinical Trials Information System (CTIS) is a centralized platform for Clinical Trial Application (CTA) and marketing authorization submissions, and supervision of clinical trials across the European Union/European Economic Area (EU/EEA). The regulation, which came into effect on January 31, 2022, aims to simplify and streamline routine clinical processes.

The new regulation enables sponsors to submit one online application via the platform for approval to run a clinical trial in several EU countries, which makes it more efficient to carry out multinational trials. The same applies to other study documents, including main study documentation and country specific documents - everything is submitted centrally within CTIS.