The European Medicines Agency (EMA) has hit an important milestone in its clinical research regulations. Since January 31, 2023, under the Clinical Trials Regulation (CTR – Regulation (EU) No 536/2014), all initial clinical trial applications in the European Union must be submitted via a single EU portal – CTIS (Clinical Trials Information System). Such submission will be followed by an assessment procedure resulting in a single decision for clinical trial authorization in Europe.

Accell has reviewed the change and is ready to assist our sponsors with the timely submission. Please read our article on the topic to learn in more detail about the regulatory update and its implications.