The European Medicines Agency (EMA, for its initials in English) has communicated that its pilot advisory program "Acceleration of Clinical Trials in the European Union (EU)" (ACT EU) will cease to be a temporary initiative to become a permanent one.
According to the regulatory body, this mechanism of technical and regulatory support, designed to help prepare research study applications, will acquire its new stable status starting in January 2027, with the aim of raising the quality of requests and speeding up evaluation processes.
With this decision, the EMA aims to strengthen collaboration across the entire network of European medicines regulatory authorities. To this end, the advisory procedure continues under the coordination of the Heads of Medicines Agencies (HMA, for its initials in English) through its Clinical Trials Coordination Group (CTCG, also for its initials in English).
A common support system for clinical trials in the EU
In practice, the "ACT EU" offers sponsors pre-submission advice on the intention to conduct a clinical trial through the Clinical Trials Information System (CTIS, for its initials in English). Since its launch in 2024, this scheme has contributed to refining applications by providing unified information from the participating member states on key issues before formal registration.
The EMA has emphasized that, before the launch of this pilot program, drug developers could only access technical and regulatory support at the national level, limited to the member state responsible for evaluating their request. The consolidation of the system as permanent, it added, will ensure the continuity of this coordinated regulatory guidance.
Furthermore, the agency has announced that by the end of the year, a summary report will be disseminated with the lessons learned from 30 of the applications processed under the program. It has highlighted that the transition to a definitive initiative aligns with the objectives of the European Biotechnology Law, by facilitating that clinical trial sponsors operate more effectively in this area.