GREECE Trends and Developments Contributed by: Angela Livgieri and Dimitra Panopoulou, ALG Manousakis Law Firm
ALG Manousakis Law Firm 16 Laodikias Street Athens 11528 Greece Tel: +30 21072 32761
Email: info@alg.gr Web: www.alg.gr
Key Changes to the Regulatory Framework for Clinical Trials in Greece under the 2026 Ministerial Decision A comprehensively revised and modernized regulatory framework for clinical research and related studies in Greece was issued through Ministerial Decision D3 (α)/52922/2025 (Government Gazette B’ 230), pub- lished on 22 January 2026 (the “Decision”), introduc- ing a substantially enhanced, efficient, and stream- lined approach to the administrative procedures, formalities and contractual mechanisms involved in clinical research. In particular, the Decision is designed to achieve the simplification and rationalisation of pro- cedures for contract execution and financial manage- ment of clinical trials with medicinal products, non- interventional studies with medicinal products, clinical research with medical devices, clinical performance studies with in vitro diagnostic products, and research projects without medicinal products, medical devices or in vitro diagnostic products. Repealing the Joint Ministerial Decision G5α/59676/22.12.2016 (Government Gazette B’ 4131), the new regime modernises Greece’s clinical trial procedures by: • introducing mandatory use of standardised nation- al contract templates; • enabling digital submissions and electronic signa- tures; and • establishing strict and explicit timelines and responsibilities for approvals and financial over- sight.
It aligns with Regulation (EU) No 536/2014 on clinical trials while significantly expanding the scope of the superseded 2016 Ministerial Decision, providing a uni- fied operational workflow for contracting and budget management across pharmaceutical products, non- interventional studies and medical devices. With the framework now in force, study teams, sponsors and institutions must promptly adapt and align their pro- cedures to comply with the Decision’s requirements. The Decision introduces significant modifications and enhancements compared with the previous regime. While the previous framework implemented the EU Clinical Trials Regulation at a regulatory level, desig- nating the Hellenic Organisation for Medicines (EOF) as the Competent Authority and the National Ethics Committee (EED) for ethical oversight, it did not estab- lish a unified system for contracting or financial execu- tion, nor did it provide national contract templates for all types of studies. The new regulatory framework systematically remedies these gaps by introducing an operational layer that spans all study types. In addition, the Decision (Articles 11 et seq) estab- lishes the national legal and procedural framework for the conduct of clinical investigations with medi- cal devices in Greece, in alignment with the Medical Devices Regulation (Regulation (EU) 2017/745-MDR) and the In vitro Diagnostic Medical Devices Regula- tion (Regulation (EU) 2017/746 – IVDR). The frame- work distinguishes between investigations conducted within and outside the device’s intended purpose and requires full compliance with MDR/IVDR, Good Clini- cal Practice (ICH-GCP), the Declaration of Helsinki and applicable national legislation. Sponsors bear
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