Security Alert
A new framework for clinical trials and related studies was issued earlier this month under Ministerial Decision No. Δ3(α)/52922/22.1.2026 (GG B’ 230) (accessible here), introducing a more streamlined approach to clinical trial processes and formalities.
Building on the Joint Ministerial Decision Γ5α/59676/22.12.2016 (GG Β’ 4131), the new regime overhauls Greece’s processes for clinical trials and related research by standardising contracts, digitising submissions and signatures, and imposing clear timelines and accountability for approvals and financial management. It complements the EU Clinical Trials Regulation framework and goes far beyond the 2016 ministerial decision 59676 by creating a unified, operational workflow for contracting and budget execution across medicines, non-interventional studies, medical devices/IVDs, and other health research.
Key takeaways
Standardised model agreements and annexes: The decision introduces uniform contract templates and associated forms covering clinical drug trials, non-interventional studies, device/IVD studies within and outside intended use, plus common budget and governance forms, all as binding annexes to be used nationally.
Centralised and digitised process: A new administrative process is established on the National Register of Administrative Procedures “Mitos” environment, with electronic submission capability and the ability to use electronic signatures across the contracting file and supporting documents.
Defined timelines and tacit approvals: The workflow sets concrete deadlines for institutional signatures (e.g., 5–8 working days in several steps) and recognises tacit positive opinions by Scientific Councils where applicable, accelerating contracting.
Unique activity codes: Each contracted project receives a unique reference code for all protocol-required procedures at the site, improving traceability and billing.
Financial management clarity: The role of ELKE/ELKEA is embedded throughout the process, including pre-signature review, signature sequencing, invoicing details, and references to zero-fee scenarios where financial management and ELKE signature are not required.
Accountability for delays: Explicit disciplinary provisions apply to unjustified delays or poor performance in contract signing or financial management.
Scope and harmonisation: The regime covers medicines, non-interventional studies, device/IVD studies (both within and outside intended use), and other research without drugs/devices, while embedding references to ICH-GCP, GVP/GPP, and GDPR in the standardised texts.
Entry into force and transition: It applies from publication in the Government Gazette and includes transitional rules for pending and approved studies already underway to be completed under the prior framework.
What has changed from the previous regime (MD 59676/2016)
From regulatory framework to operational contracting: MD 59676/2016 implemented EU CTR 536/2014 at a regulatory level (designating EOF as Competent Authority and EED for ethics), but did not create a unified contracting/financial execution system or national contract templates for all types of studies. The 2026 decision adds that operational layer across study types.
Centralised administrative pathway via Autonomous Clinical Trials Department (in Greek: ATKM) and National Register of Administrative Procedures (ΕΜΔΔ)“Mitos”: The new process channels submissions through the site’s Autonomous Clinical Trials Department or administration secretariat and sets expedited handoffs to ELKE/ELKEA with fixed deadlines—something not provided in MD 59676/2016.
Standard model agreements with embedded compliance: The templates integrate references to ICH-GCP and ethics norms, and for non-interventional research GVP/GPP, driving consistency in obligations and oversight—again absent from MD 59676/2016’s text.
Digitisation and e-signatures: The 2026 decision enables electronic filing and e-signatures across the contract dossier, while MD 59676/2016 did not establish such digital mechanics for contracting.
Explicit timelines and tacit opinions: The new regime codifies institutional signature windows (e.g. 5 or 8 working days) and recognises tacit positive opinions from Scientific Councils in certain steps, shortening the “time to signature”. MD 59676/2016 did not contain these contracting timelines.
Unique codes for protocol-required procedures: Assigning a unique reference code to each contracted project/site creates a clear basis for internal coordination and billing—this operational detail is new.
Clear allocation of financial roles and zero-fee paths: The 2026 decision specifies ELKE/ELKEA’s review and signature role, invoicing particulars, and excludes ELKE/ELKEA signature where budgets are zero—a refinement not present in MD 59676/2016.
Accountability measures: Introduction of disciplinary measures for unjustified delays in contracting or financial management—another novel mechanism compared with MD 59676/2016.
Pharmacy supply and reimbursement clarity: IMPs and related products may be ordered via the site pharmacy and reimbursed by the sponsor to the site, clarifying pathways often handled ad hoc under the older regime.
Next implementation steps
With the new framework now in effect, research teams, sponsors, and institutional bodies need to adapt their processes to align with the 2026 decision. The following steps highlight practical actions to ensure studies comply with the new contracting, submission, and financial management requirements. By planning ahead and leveraging the digital tools, teams can minimise delays and ensure smooth implementation under the updated framework.
Research teams, sponsors, and institutional bodies should use the national templates and annexes for each study type, including the budget and research team forms, and align drafts to the annex language.
Submissions should be routed through the Autonomous Clinical Trials Department/site administration, with swift turnarounds to and from ELKE/ELKEA under the new deadlines; internal sequencing should be planned to meet the 5–8-day windows.
Electronic submission and e-signatures should be leverages to avoid paper delays and ensure complete electronic files are accessible to all involved services.
Each project should be assigned a unique activity code and finance/invoicing references should reflect that code consistently.
For non-interventional and device/IVD research, responsible parties should apply the specific filing contents, tacit opinion constructs, and contracting steps detailed in the new decision.
Effective date and transition
The decision takes effect upon publication in the Government Gazette; pending and ongoing studies at the time of entry into force will be completed under the framework set out in the transition clause.