Mandatory use of the Clinical Trials Regulation now in force in EU

Today (January 31) marks the start of the mandatory application of the Clinical Trials Regulation for all new clinical trials. It is a significant milestone in the transformation of the oversight and management of clinical trials in the European Union.

The European Medicines Agency (EMA) pointed out that this follows a one-year transition, during which sponsors could choose whether to apply for a new clinical trial in the EU/EEA in line with the Clinical Trials Directive or under the new Clinical Trials Regulation (CTR), which entered into application on January 31, 2022.

In the past, sponsors had to submit clinical trial applications separately to national competent authorities (NCAs) and ethics committees in each country to gain regulatory approval to run a clinical trial. Registration and the posting of results were also separate processes. With Clinical Trials Information System (CTIS), sponsors can now apply for authorizations in up to 30 EU/EEA countries at the same time and with the same documentation. The system includes a public, searchable database for healthcare professionals, patients, and other interested parties.