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04.04.2022

What does EU’s new regulation on CTIS mean for pharmaceutical companies and their clinical trials?

With the European Economic Area remaining an attractive location for clinical research investment, the introduction of the EU’s regulation No. 536/2014 on the Clinical Trials Information System (CTIS) at the end of January 2022 caused a major overhaul within the industry. However, while industry insiders believe it may bring some short-term hassles and challenges, they are positive that things will work out further down the road. 

The CTIS is a publicly accessible platform that contains data submitted in accordance with the Clinical Trials Regulation (CTR). The platform was set up to streamline the flow of information between EU member states and increase transparency under the new regulation. Besides, it will strengthen the European landscape for clinical studies, while maintaining a high level of safety for study subjects.  Regarding country-specific documents, everything is now being submitted centrally within the portal system, which will immediately make trials easier to run across multiple EU countries. 

 “It means that we will submit only one online application in one country for running a trial in several EU countries. The initial submission documentation package, including main study documentation and country-specific documentation, has to be uploaded on to the CTIS for all countries involved in the research. This novel approach aims to promote greater public awareness and understanding of the clinical trial industry in general,” experts from OCT Clinical commented. 

 Among other key benefits of the new regulation, industry experts identified a more solid legal footing, reduced regulatory burdens carried by each individual EU member state due to a single timeline or review, and approval for all countries selected for submission. 

 
 

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