When you absolutely have to recruit patients on time.

Home 5 Company News 5 European Union Clinical Trial Regulation 2023 update

European Union Clinical Trial Regulation 2023 update

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.

Company News

This Is Your Team. We Make Clinical Trials Happen.


our SERVICES MENU


From clinical research associates to hands-on founders, we fiercely pursue our strategic goal: deliver on schedule. We think of ourselves as your development partner, not a vendor.