CTR 536/2014: CTIS - the single entry point for submitting clinical trials in the EU (Part 2)

Posted by Tatiana Dicenzo on Feb 14, 2023 9:37:00 AM

In January 31st, the Clinical Trials Information System (CTIS) became the single entry point for submitting clinical trials in the European Union. Exactly one year before the one-year transition period started sponsors could choose whether to use CTIS to submit a clinical trial application under the Clinical Trial Regulation or keep submitting clinical trials in line with Clinical Trial Directive requirements.

During this transition period, CTIS users encountered many challenges regarding the functionality of the system. In November 2022, the Working Group of Ethics Committees in Germany (Arbeitskreis Medizinischer Ethik-Kommissionen in der Bundesrepublik Deutschland – AKEK) together with associations representing applicants for drug trials from universities and the pharmaceutical industry issued a joint press release [1]. It stated that deficiencies and shortcomings of the system were impairing the processing of clinical trial applications by the ethics committees. The press release was followed by a call to postpone the January 30th deadline as the last day to apply for a clinical trial under the Clinical Trial Directive. 

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Although it seems that the appeal was not heard by the European Medicines Agency (EMA), in December last year, the agency allocated extra resources for solving blocking issues in the main CTIS processes and submitted a plan for the member state authorities that included workaround processes to address many deficiencies in CTIS functionalities. A CTIS event was organized on 20th January 2023 by the European Medicines Agency to provide information about the “Readiness for mandatory use of the Clinical Trials Regulation” [2].

The German Federal Institute for Drugs and Medical Devices (BfArM) is confident [3] that errors have been largely corrected in the last month and the stability of CTIS has also improved significantly.


Although sponsors might still encounter some challenges while using CTIS to apply for clinical trial authorisation, the advantages [4] of the system for phase III and phase IV trials are undeniable. With CTIS, sponsors can apply for a clinical trial in up to 30 countries within the European Union/EEA simultaneously with one single application, making the European Union much more attractive for the conduct of clinical trials [5].


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Topics: Clinical Trials in Diabetes, Clinical Trial Methods, Regulatory Affairs