Innovation and scientific advice | Italian Medicines Agency Aifa toggle bar Search Search keywords The Agency The Agency Mission and values Organisation Scientific and Economic Committee for Medicines Support and Coordination Secretariats and Advisory Committees International Collaborations EU Projects Legislation Forms Competition notices Resolutions Tenders and contracts Quality assurance Guarantee Committee Atti di notifica Associazioni dei pazienti AIFA Incontra Contacts Certified email COVID-19 COVID-19 Communications about COVID-19 COVID-19 Vaccines Medicines usable for treatment of COVID-19 disease Use of monoclonal antibodies for COVID-19 Use of antivirals for COVID-19 Monitoring of medicinal products used during the COVID-19 epidemic Clinical Trials - COVID-19 Compassionate Use Programs - COVID-19 Access to medicinal products Access to medicinal products Early access and off-label use Authorisation of medicinal products Medicine shortages Antibiotic medicinal products Biological medicinal products Vaccines Blood derivatives Generic medicinal products Biosimilar medicinal products Orphan medicinal products Advanced therapies Homeopathic medicinal products Allergens Medicinali di origine vegetale Ancillary medicinal substances incorporated in medical devices Safety of medicinal products Safety of medicinal products Pharmacovigilance National Pharmacovigilance Network Adverse Reactions to medicinal products Persons in charge of Pharmacovigilance European Eudravigilance System Accesso alle segnalazioni - ADRreports Regional pharmacovigilance funds Segnali di sicurezza Risk management measures Medicinal products subject to additional monitoring Quality and Inspections Quality and Inspections Quality defects Inspections and authorisations Qualified person Fight of pharmaceutical crime Research and Clinical trials Research and Clinical trials Clinical trials concerning medicinal products EU Regulation on Clinical trials National Observatory on Clinical Trials Registro Studi Osservazionali Comitati Etici Nazionali (CEN) Ethics Committees Coordination Centre Independent clinical research Mappa dei centri di Sperimentazione Clinica Pricing and reimbursement Pricing and reimbursement Negotiation and reimbursement Economic evaluations Monitoring Registers AIFA Notes Lists of Class A and Class H medicinal products Innovative medicinal products Transparency Lists Consumption and pharmaceutical expenditure Consumption and pharmaceutical expenditure The Medicines Utilization Monitoring Centre (OsMed) Governance of pharmaceutical expenditure Monitoring pharmaceutical expenditure Innovation and planning Innovation and planning Innovation and scientific advice Horizon scanning Information and communication Information and communication FarmaciLine Medical and scientific information FAQ Publications Communication campaigns Eventi AIFA Scientific Seminars Press releases Dossier AIFA Mobile APP AIFA APP Firstline AIFA - Antibiotici ABC della Ricerca Clinica Presentations and speeches Public consultations and documents Documents shared with scientific communities Calendario eventi Archivio AIFA data AIFA data OsMed Data Open Data Companies Section Companies Section Requests for authorisation of conferences and meetings Payment of fees and annual duties MA Electronic invoicing Application for reimbursement and pricing Access information Notifica concessionari di vendita Comunicazione prima commercializzazione Open governance Open governance Disposizioni Generali Organizzazione Consulenti e collaboratori Personale Bandi di Concorso Performance Enti controllati Attività e procedimenti Provvedimenti Bandi di gara e contratti Sovvenzioni, contributi, sussidi, vantaggi economici Bilanci Beni immobili e gestione patrimonio Controlli e rilievi sull'Amministrazione Servizi Erogati Pagamenti dell'Amministrazione Opere pubbliche Pianificazione e governo del territorio Informazioni ambientali Interventi straordinari di emergenza Altri Contenuti Innovation and scientific advice Innovation and scientific advice Scientific and technological progress applied to the development of medicinal products poses new challenges to the regulators and new approaches are necessary to respond to new needs. The ultimate goal is to guarantee patients timely access to technological innovations, in compliance with the regulatory tasks entrusted to AIFA for the protection of public health through medicinal products. In this context, AIFA promotes early comparison and interaction with public or private actors engaged in the development of new methodologies and technologies applied to the development of pharmaceutical products, such as advanced therapies, borderline products, nanotechnologies, with the aim of providing scientific and regulatory support, with particular regard to the requirements necessary for successful development. The Agency is also connected to the European network of the EU-Innovation Network (EU-IN , a platform for linking national academic and research realities and the European regulatory institutions, to facilitate access to the regulatory and scientific tools that the European scenario can offer and to ensure the identification of new technologies and their timely classification in the regulatory framework. The EU-IN, through the sharing of information on emerging innovative products and technologies, allows the discussion of individual cases with the Innovation Offices of the other Member States and with the EMA (with the consent of those who developed the product),in order to identify any deficiencies in the current regulatory framework that could hinder the development. The EU-IN thus contributes to the consolidation of a shared scientific-regulatory position in relation to particular areas of competence and to the identification of training needs of the network in support of the EU Network Training Centre (EU-NTC) In this context, the objectives of AIFA are: informally inform and guide the developers of innovative products towards the activities that AIFA or EMA use to support innovation during its development path up to market entry carry out a proactive survey on the level of innovation in the field of research and development of new medicinal products in the national territory. It is possible to request an Innovation Meeting, an informal meeting during which it is possible to present an innovative product, technology or methodology in order to receive feedback or guidance on the evolution of the development programme. Who can request an Innovation Meeting Pharmaceutical industries Small and medium-sized enterprises Universities and Academic Institutions Research Institutions AIFA/EMA/HMA-Translating Innovation into access for ATMPs AIFA/EMA/HMA - Translating Innovation into access for ATMPs EU-Innovation Network: guidance on available scientific and regulatory support tools at national and European level Questa linea guida, destinata agli sviluppatori di farmaci, metodologie e tecnologie innovative, fornisce una panoramica degli strumenti di supporto regolatorio a livello nazionale ed europeo. L’obiettivo è facilitare l’orientamento all’interno del processo di sviluppo attraverso l'individuazione delle modalità di interazione regolatoria più appropriate. EU-Innovation Network EU-Innovation Network: guidance on available scientific and regulatory support tools at national and European level [0.53 Mb] [PDF] > EU-Innovation Network: launch of the pilot for Simultaneous National Scientific Advice (SNSA) SNSA - Documents [0.74 Mb] [ZIP] > EU-Innovation Network: continuation and further development of the pilot project Simultaneous National Scientific Advice (SNSA) during 2025 Simultaneous National Scientific Advice (SNSA) - Continuation and further development during 2025 [0.12 Mb] [PDF] > Launch of phase 2 of the Simultaneous National Scientific Advice pilot [0.29 Mb] [PDF] > List of NCA’s participating in the Simultaneous National Scientific Advice (SNSA) pilot phase 2 [0.17 Mb] [PDF] > Guidance for applicants on Simultaneous National Scientific Advice (SNSA) phase 2 pilot (from October 2022) – Optimized process [0.29 Mb] [PDF] > Guidance for applicants on Simultaneous National Scientific Advice (SNSA) Briefing book format and content [0.17 Mb] [PDF] > Application form to request a Simultaneous National Scientific Advice (SNSA) [0.09 Mb] [DOCX] > Update SNSA 17/02/2025 Italian Medicines Agency participates in the Simultaneous National Scientific Advice (SNSA) pilot as observer. Documents  relating to the project are  available on the website of the European Medicines Agency (EMA). Related links Request for an Innovation Meeting Related links EU Network Training Centre (EU-NTC) EU-Innovation Network (EU-IN) (HMA) EU-Innovation Network (EMA) Innovation and planning Innovation and scientific advice Horizon scanning Share Nested Applications Highlights 21/04/2026 - Medicine Use: 2024 Regional Reports Now Available Online 17/04/2026 - From one-size-fits-all treatments to personalised care: the revolution in precision medicine TUTTE LE NEWS - IN EVIDENZA ALL NEWS News 21/04/2026 Medicine Use: 2024 Regional Reports Now Available Online 15/04/2026 AIFA updates the Transparency Lists 13/04/2026 Medicine Shortage Communication on Endoxan (ciclofosfamide) All news Nested Applications Press From one-size-fits-all treatments to personalised care: the revolution in precision medicine All press releases Last tweets 📢 #AIFA comunica il calendario degli incontri nell’ambito delle iniziative dedicate al dialogo e al... 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