The clinical trials regulation in Greece, published in the Government Gazette (ΦΕΚ) 230/B/22.01.2026, establishes a unified and simplified framework for contracts and financial management of clinical trials, non-interventional studies, and other health research projects. This clinical trials regulation in Greece directly affects clinical trials with medicines, studies involving medical devices, and research conducted in hospitals and public health institutions, aiming to reduce bureaucracy, ensure transparency, and protect participating patients.
WHY THE NEW DECISION WAS NECESSARY
Until now, procedures for signing contracts for clinical trials and studies were often delayed, complex, and varied between institutions. This slowed down research and discouraged sponsors and research teams. The new Ministerial Decision aims to create a clear, unified framework with common standards, defined responsibilities, and specific timelines.
WHAT CHANGES FOR CLINICAL TRIALS AND STUDIES
Under the new regulation:
-
Standardized contracts for clinical trials and studies are introduced,
-
Clear deadlines for contract signing are established,
-
The use of electronic procedures is promoted,
-
The financial management framework of research projects by responsible institutions is clarified.
These changes aim to reduce administrative burdens and facilitate the daily operations of research teams and health institutions.
WHAT THIS MEANS FOR PATIENTS
Of particular importance is the reaffirmation that participating patients are not financially burdened by their involvement in clinical trials or studies. The costs of examinations, procedures, and services related to the study are covered by the sponsor, ensuring the protection of patients’ rights and safety, and reinforcing trust in the research process.
WHY THIS REGULATION IS AN IMPORTANT STEP FOR RESEARCH IN GREECE
The Ministerial Decision published in the Government Gazette (ΦΕΚ 230/B/22.01.2026) represents a significant step toward improving the research environment in Greece. By creating unified and clear procedures for contract signing and financial management of clinical trials and studies, it reduces long-standing administrative barriers that delayed the implementation of research projects. At the same time, it strengthens institutional security for all stakeholders—researchers, health institutions, and sponsors—while fostering transparency and accountability.
In this context, Greece can become more competitive in research, facilitate participation in international research initiatives, and make more effective use of its scientific knowledge and human resources. In the healthcare field, accelerating and streamlining processes helps align research more closely with clinical practice and patients’ real needs, benefiting society as a whole.
Kapa3 closely monitors institutional developments affecting health research and clinical trials, highlighting their importance for patient protection and the improvement of care quality.
Text/adaptation: Ifiyenia Anastasiou for Kapa3