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Accelerating Clinical Trials in the EU
Support mechanisms for non-commercial clinical trials Level
NationalEU Level (Multinational)Global
Dedicated webpage    
Training courses    
Scientific advice     
Helpdesk, regulatory, CTIS and ethics support
  • General webpage on clinical trials
  • FAQs
  • Dedicated mailboxes for support on CTs, including non-commercial CTs: reg [dot] eu [dot] sperimentazioniataifa [dot] gov [dot] it (reg[dot]eu[dot]sperimentazioni[at]aifa[dot]gov[dot]it) for all CT related questions and  CTRataifa [dot] gov [dot] it (CTR[at]aifa[dot]gov[dot]it) for practical questions related to CTs in CTIS
  • Webpage of the National coordinating committee for ethics committees, with guidance and FAQs
Other services by National Competent Authority

NCA fee reduction or waiver

As per the Ministerial Decree of 30 November 2021, no fees are requested for the submission of the Clinical Trial Application (full fee waiver).

Services by ethics committeeAs per the Ministerial Decree of 30 November 2021, no fees are requested for the submission of the Clinical Trial Application (full fee waiver).XXX
Public GCP support    
Public research office

AIFA Independent research office: financial support to non-commercial clinical studies and clinical trials

AIFA's independent research programme is aimed at all Italian researchers from public and non-profit institutions. The research programme is financed by a share of a national fund consisting of a contribution equal to 5% of the promotional expenses incurred annually by pharmaceutical companies. Studies supported by the Agency are those aimed at:

  • comparisons between medicines to demonstrate additional therapeutic value;
  • studies on orphan drugs and rare diseases;
  • studies on prescriptive appropriateness and optimisation of therapeutic strategies;
  • studies on the safety profile of medicines.

Calls for funding of independent research are usually published periodically and are constantly updated, in order to suit to the new needs arising in the health sector.

The Office also provides general support to non-commercial sponsors on regulatory issues, if requested.

International studies can be covered, however the funding is limited to national sites and researchers only.

General Directorate of research and Innovation at the Ministry of Health: The Directorate publishes a public call on a yearly basis for grants on clinical and nonclinical studies and clinical trials performed by the Institutes for Hospital care and Research (IRCCS), with a dedicated section for young investigators.

National funding and other financial support
  • As per the Ministerial Decree of 30 November 2021, the costs of the Investigational Medicinal Products (IMPs) are covered by the National Health Service (NHS) if they are investigated in an indication already reimbursed by the NHS, including "off label" indications used in normal clinical practice if already approved by AIFA for reimbursement by the NHS according to Law 648/96;
  • AIFA has a dedicated fund to support non-commercial clinical studies and clinical trials (Law 326/2003, see above “public research office”);
  • Yearly call for grants dedicated to IRCCS, funded by the Ministry of Health (see above “public research office”);
  • Other grants can made available by the Ministry of Research.
Funding coordination and navigation of research infrastructure    
Support identifying research networks    
Other support mechanisms

Additional costs of non-commercial trials can be covered by dedicated funds, which are mandatory for public health institutions according to Ministerial Decree of 30 November 2021. These funds can be constituted by specific research funds already available at the clinical site and can be further financed by revenues related to contracts with commercial sponsors for the conduct of commercial clinical trials at the concerned clinical site.