EMA Highlights – October 2025

In October 2025, the European Medicines Agency (EMA) published updates on the implementation of the EU Clinical Trials Regulation (“CTR” No. 536/2014) and the development of the Clinical Trials Information System (CTIS). The report confirmed the full completion of the three-year transition period, which began in January 2022 and ended on 30 January 2025. The CTR replaced the previous Clinical Trials Directive (2001/20/EC), establishing a harmonised and simplified framework for the authorisation and oversight of clinical trials across the European Union (EU) and European Economic Area (EEA). This transition period allowed sponsors to move ongoing studies from the former EudraCT system to the new CTIS platform, which now serves as the only entry point for all EU clinical trial applications, notifications, and publications. 

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The report highlighted significant progress in the adoption of CTIS. A total of 10,608 clinical trial applications were submitted between January 2022 and January 2025. Among these, 5,001 were new initial submissions, 5,088 were transitioned from EudraCT, and 519 were resubmissions. Among the applications that received a final decision, either authorised or not, over 8,500 were authorised, resulting in an approval rate of 98.4%. Around 1,200 applications were withdrawn, lapsed, or deemed invalid, often due to incomplete documentation or voluntary sponsor withdrawal. The successful completion of this transition marked a major step towards a more transparent, efficient, and collaborative European research environment. 

The EMA report also described the ongoing developments within CTIS, focusing on usability and accessibility. One of the most significant new features introduced in 2025 was the ability for users to search for clinical trials in their own language https://euclinicaltrials.eu/search-for-clinical-trials/trial-map/?lang=it. This improvement addresses the challenge faced by laypersons who previously found it difficult to understand trial information presented only in English. By allowing searches in all official EU languages, CTIS now ensures that patients, caregivers, and the public can access clear and comprehensible information on ongoing and completed trials. This represents a major milestone in fulfilling the CTR’s commitment to transparency and public engagement, making clinical trial data truly accessible to European citizens regardless of their language skills. 

The system’s multilingual functionality is accompanied by continuous efforts to simplify the user interface and enhance data quality. CTIS now provides harmonised templates and improved workflows for sponsors and regulators, making it easier to submit, review, and authorise trials across multiple Member States simultaneously. During the transition period, approximately 42% of trials were multinational, while 58% were conducted within a single country. This balance is expected to shift as the new framework encourages more cross-border collaboration, supported by the single submission and evaluation process managed through the Reporting and Member States Concerned (RMS and MSC) system. 

Further technical and procedural developments in CTIS include optimised modules for safety reporting, management of substantial modifications, and improved functionalities for low-intervention trials. Between 2022 and 2025, over 11,700 substantial modification applications were processed, mostly from commercial sponsors. Additionally, 1,370 requests were submitted to add new Member States to ongoing trials, showing a growing trend towards multi-country studies. Non-commercial sponsors—such as hospitals, academic institutions, and research networks—accounted for about half of all trial applications, highlighting their essential contribution to EU research despite limited resources compared to industry sponsors. 

The report provided a detailed analysis by therapeutic area, trial phase, age group, and gender representation. It noted an encouraging inclusion of both sexes in nearly 90% of authorised trials and increasing representation of elderly participants. Approximately 13% of all studies were classified as low-intervention clinical trials, with non-commercial sponsors leading this category, reflecting growing interest in pragmatic and real-world research. Furthermore, 141 authorised trials involved advanced therapy medicinal products (ATMPs), demonstrating Europe’s ongoing commitment to supporting innovation in gene and cell therapies. 

The completion of the CTR transition also reinforced the roles of national competent authorities as Safety Assessing Member States (saMS), responsible for evaluating serious adverse reactions and annual safety reports across clinical trials involving the same investigational substance. This harmonised approach ensures consistent safety surveillance throughout the EU. 

Finally, the EMA highlighted the broader benefits of the CTR and CTIS for Europe’s research ecosystem. The system’s integration has streamlined procedures, reduced duplication, and enhanced transparency. The public website now displays comprehensive information about every authorised trial, including lay summaries, results, and sponsor details. The October 2025 update emphasised that multilingual search capabilities and simplified trial access tools are essential steps in making clinical research more inclusive and understandable for all Europeans, regardless of scientific background. 

In conclusion, by October 2025, CTIS had become the cornerstone of the EU clinical research landscape. The transition from EudraCT was successfully completed, with over five thousand trials migrated and thousands of new ones authorised under the CTR. With ongoing improvements in language accessibility, interface design, and data transparency, CTIS now stands as a unified, user-friendly, and multilingual platform that strengthens public trust and facilitates innovation in clinical research throughout the European Union. 

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