First published in April 2014, the Clinical Trials Regulation only became fully applicable on January 31, 2022.
Previously, the conduct of clinical trials in the EU had been governed by the Clinical Trials Directive, regulation dating back to 2001.
Andrzej Rys, director for health systems and products, EU Commission, said the rules for conducting clinical trials throughout the EU are now harmonized, offering a one-stop shop for applications of clinical trials and their supervision through the Clinical Trials Information System, which includes an online portal and database.
Benefits for sponsors
“This will make it easier to register, assess, authorise, conduct and supervise clinical trials in the EU, particularly those that take place in several Member States. At the same time, the new system will make trials and their results much more transparent for the public. This is a huge step forward compared to the current situation in which sponsors need to apply separately to National Competent Authorities and ethics committees in each member state.”
For sponsors of clinical trials, the new legislation enables them to apply for a clinical trial in all European Economic Area (EEA) countries with one application.
“The system will also make it easier to recruit trial participants by allowing sponsors and researchers to easily expand trials to other EEA countries. Sponsors, researchers and national competent authorities from different countries will be able to share knowledge and to collaborate more easily, thus avoiding duplicating efforts and achieving better results,” continued Rys.
Having a single online platform, called the Clinical Trials Information System, makes it easy for the public to find information about the approval, execution and result of a given clinical trial he said.
Every year, some 4000 clinical trials are authorised in the EU. About 80% of the clinical trial applications are submitted by a commercial organisation, the rest are by non-commercial entities, like universities, noted the representative.
The European Medicines Agency (EMA), the Heads of Medicines Agencies and the Commission are currently setting up a project portfolio that aims to make the EU more attractive for clinical research and to ensure that the objectives for clinical trials set out in the EU Pharmaceutical Strategy can be met, said Rys.
“These include conducting patient-oriented research, providing guidance of complex trial designs, better integrating the medicines development cycle and improving research preparedness in public health crises.”