One year after its launch, the CTIS portal suffers from serious deficiencies, severely impairing the application procedure for clinical studies in all of Europe.
Since end of January and after a one year transition period, approval for new clinical trials of medicinal products in Europe can only be done via the electronic CTIS portal of EMA. CTIS is part of EU Regulation 536/2014 (CTR) and was installed to facilitate and expedite the approval process in Europe.
Instead, it’s insufficient functionality now threatens the entire European landscape of drug research. The German magazine transkript published an article, which shows alarming figures: It is to be feared that the dysfunctionality of the CTIS portal will lead to a potentially permanent migration of drug trials to other regions of the world and in the worst case to significant deterioration in the supply situation of seriously ill patients with innovative drugs.
An alliance of industry organizations, including the BVMA (German Association for Contract Research Organizations), where FGK’s Managing Director Martin Krauss is President, urge rapid action by politics to save the competitiveness of Europe as a research location: Klinische Studien im Sinkflug (©|transkript 1-2023)