AIFA publishes the Call for Independent Research 2025 on Rare Diseases which allocates 17,800,000 euros to independent scientific research for the promotion of studies on low-prevalence pathologies that often do not attract significant commercial investments.
The call is aimed at all Italian researchers from bodies and institutions who intend to conduct non-commercial studies and is financed with a quota deriving from art. 11 of the Consolidated Law on Rare Diseases (Law 175/2021) which has provided for a 2% increase in the Fund constituted by the contribution of promotional expenses incurred annually by pharmaceutical companies.
The main objective is to encourage the development of effective drug therapies for rare diseases to improve the health and quality of life of patients.
Starting from 10:00 on Monday 9 June 2025 and until 12:00 on Wednesday 23 July 2025 , it is possible to submit your study proposal through the new Independent Research System (SRI) available on the AIFA Online Services portal .
For the requirements of the call and the application methods, the text of the call and its two attachments, the PI User Manual and the related FAQs are made available.
For any support regarding the use of the application's features, you can contact the dedicated service at the following addresses:
AIFA funds independent studies focused on:
Comparative effectiveness between drugs
Orphan diseases
Prescriptive appropriateness
Drug safety and information initiatives
Your study must clearly serve public health needs over commercial interests.
Stay aligned with current calls (e.g., 2025 rare disease call, €17.8M total) focusing on:
Preclinical/clinical pharmacological therapies
Drug repurposing
Plasma-derived orphan drugs
Demonstrate how your project fulfills these thematic priorities.
Applicants must be affiliated with a public or private Italian research institution.
Use the AIFA portal for online submissions; ensure all required documents are included to avoid outright disqualification.
Proposals should show:
Clear clinical endpoints
Solid statistical plans
Preclinical justification where applicable
Feasibility of activities such as off-label use, drug safety data collection
Emphasize clinical unmet needs and potential added therapeutic value.
Include high-quality evidence to support hypotheses and implementation feasibility.
Calls are released periodically—e.g., June–July 2025 rare disease call
Monitor the AIFA website closely and submit early within the window.
Include commitments from ethics committees, regulatory oversight, and patient recruitment strategies.
Clearly state team expertise, institutional support, access to necessary infrastructure, and defined project timelines.
✅ Summary Table
Predictor | What You Should Do |
---|---|
Non-commercial focus | Center on orphan drugs, comparative studies, or safety |
Priority alignment | Tailor your proposal to the current call’s themes |
Institutional eligibility | Apply through Italy-based public/private research institutions |
Methodological rigor | Provide solid statistical and clinical research frameworks |
Clinical need & evidence | Show clear unmet needs and added value |
Regulatory readiness | Prepare ethics/CTIS documentation preemptively |
Complete & compliant submission | Follow portal instructions meticulously and meet deadlines |
🛠️ Final Tips
Map your study carefully to the call’s focus (e.g., rare diseases in 2025).
Prepare ethics and regulatory documentation early—Italy offers fee waivers for non-commercial trials
Build a strong Italian institutional team, with infrastructure and patient access.
Detail methodological rigor, including statistical design, data quality, and endpoints.
Highlight public health impact, not commercial potential.
Submit complete proposals early and ensure no required attachments are missing.
This Call, taking into account the Consolidated Law on Rare Diseases, provides that the study proposal falls within one of the following lines of investigation:
Eligible Countries:
Sponsor Institute/Organizations: Italian Medicine Agency
Sponsor Type: Corporate/Non-Profit
Address: Via del Tritone, 181 00187 Rome
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Jul 23, 2025
$1,177,648
Affiliation: Italian Medicine Agency
Address: Via del Tritone, 181 00187 Rome
Website URL: https://www.aifa.gov.it/en/bandi-2025#
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