The European Medicines Regulatory Network, in a joint response dated 2 July 2026, outlined a series of measures to improve sponsors' compliance with legal requirements to publish clinical trial results in the Clinical Trials Information System (CTIS), addressing concerns raised by Health Action International and other health groups. The response, signed by EMA Management Board Chair Rui Santos Ivo on behalf of the network, was published by EMA on 13 July 2026.
The letter responds to a 15 June 2026 communication from Health Action International and supporting organisations, which included a policy brief and suggestions for improving compliance with Article 37 of the Clinical Trials Regulation 536/2014 (CTR). The CTR, which entered into application in 2022, requires sponsors to submit a summary of trial results and a layperson summary to CTIS within applicable timelines after a trial ends. The network acknowledged the groups' support and proposals, noting that monitoring compliance is a shared responsibility among EU/EEA Member States, the European Commission, and EMA.
To increase compliance, the network detailed several ongoing and planned actions. CTIS now provides sponsors with system notices and alerts, recently supplemented by direct email notifications. Enhanced monitoring capabilities have been developed to track timely submission and publication of trial results per Member State. Training materials for sponsors have been revised, with improved guidance in the sponsor handbook on how to submit results. Regular reminders of transparency obligations are sent through established channels such as national contact points via the Commission's Expert Group CTAG, the ACT EU Multi-stakeholder Platform Advisory Group, and the Clinical Trials Highlights newsletter. By the end of 2026, quarterly reports on the EU clinical trials environment will include the number of trials with available summaries of results, published on the ACT EU website. Member States are also considering further national-level measures to improve compliance.
The network highlighted additional transparency initiatives, including the revision of CTIS transparency rules in June 2024 to ensure timely access to clinical trial data, and the Clinical Trials Map launched in March 2025, designed to provide patients and healthcare professionals with easy access to real-time information about clinical trials. The ACT EU 2026-2027 workplan includes a communication campaign targeting sponsors, emphasising timely submission of high-quality data to CTIS, with actions under consideration including measures previously used to successfully increase results posting in EudraCT. The network also noted that clinical data submitted as part of marketing authorisation applications are published on both EMA's website and CTIS public website, helping researchers reassess data, avoid duplication, and build public confidence.
The response indicates that the letter and policy brief were discussed by the ACT-EU Steering Group and will be shared with EMA's Management Board for awareness. EMA, the European Commission, and the Heads of Medicines Agencies will closely monitor the impact of these measures and continue to review the need for further action to ensure timely publication of clinical trial results.