November 2022: Germany Call for Extension, Owing to EU CTIS Functional Problems

An article “Massive functional problems of the EU portal CTIS for clinical trials threaten drug research in Europe“, was published on the Bundesverband der Pharmazeutischen Industrie (BPI) website on November 28, 2022, by the Working Group of Medical Ethics Committees in the Federal Republic of Germany (AKEK).  A similar article was also published on the sueddeutsche zeitung website on December 01, 2022.

German Pharma trade organizations, association of ethics committees, and applicants from academic research have drafted a letter requesting an extension to the transitional period for EU CTIS pursuant to Article 98 (2) of Regulation 536/2014, expiring on 31 January 2023.

The letter raises concerns associated with the functionality and shortcomings of the CTIS portal. The thorough review of research proposals by ethics committees is severely hampered by the dysfunctional nature of the portal. Due to such issues, the application for clinical trials and their processing by the ethics committees are massively impaired and cannot be managed. Also, this would have negative consequences on early access to new therapies for patients in Germany and the European Union.

The signatories to the letter consider it essential that the transition be extended until the EU CTIS portal is well established. The federal government is also urgently requested to bring about such an extension in a timely manner together with other EU member states.