The Clinical Trials Information System (CTIS) of the European Medicines Agency (EMA) marks a milestone in the administration and monitoring of clinical trials in the EU. What was previously a logistical nightmare due to differing national regulations is set to come to an end with the deadline for the changeover on January 31, 2025. Regulation (EU) No. 536/2014 (CTR), which was adopted in 2014, aims to eliminate these challenges and simplify access to clinical trial information.

Objectives of the CTIS

• Harmonization and simplification: the system standardizes the process of submission, assessment and monitoring of clinical trials across the EU

• Transparency: CTIS makes information on clinical trials publicly available to increase public confidence and inform the scientific community

• Protection of participants: improved safety monitoring and reporting will better protect the welfare of trial participants.

• Increasing efficiency: the system reduces administrative duplication and speeds up the start of trials.

This marks significant progress towards more transparency and collaboration in clinical research and brings numerous benefits for all parties involved:

• Researchers and sponsors: simplified submission, faster approvals and clear communication.

• Patients and the public: Increased access to information and increased trust.

• Regulatory authorities: More efficient collaboration and consistent assessment and monitoring of studies.

Deadline for the transition on January 31, 2025 - the countdown is on

This date marks the end of the three-year transition period. All ongoing clinical trials in the EU must be fully converted to CTR and the Clinical Trials Information System by January 31, 2025. So far, only around 30% of trials have been successfully converted - that means 70% are still pending!

Are you one of the 70%? The transition to CTIS is a comprehensive process that involves several steps and must be carefully planned and executed by all parties involved.

Challenges and implementation

The transition to CTIS brings with it several challenges. Overall, the entire transition process can take 4 to 7 months, depending on the size and complexity of the studies, the number of stakeholders involved or the efficiency of implementing the individual steps. Organizations and institutions must start planning early to allow sufficient time for the transition and minimize potential delays. With the deadline for full transition approaching on January 31, 2025, there is an urgent need to start taking the necessary steps.

Given the necessary steps and timeframe for the transition to the Clinical Trials Information System (CTIS), we offer professional support from competent freelancers. These experts can help organizations overcome the challenges of the transition and ensure that all steps are completed promptly and efficiently. If you have any questions, please contact us directly on +49 89 1890998-11.

Sources:

Europe updates CTIS to support more transparent trial reporting (clinicaltrialsarena.com)

BfArM - Clinical Trials Information System - CTIS (BfArM)

Regulation - 536/2014 - EN - EUR-Lex (europa.eu)

Umstieg von Klinischen Prüfungen auf die Clinical Trials Regulation – BASG (www.basg.gv.at)

EMA veröffentlicht überarbeitete CTIS-Transparenzregeln - GMP Navigator (gmp-navigator.com)

Klinische Prüfungen: Künftig einheitlich in der Europäischen Union (aerzteblatt.de)

Clinical Trials Information System | European Medicines Agency (ema.europa.eu)

*Note: The above timeframes are indicative estimates. Detailed information and specific requirements can be found in the EMA guidelines and publications as well as in experience reports from institutions that have already started the transition.