Italy

Italy's health product regulatory framework is administered by multiple competent authorities depending on product type. The Agenzia Italiana del Farmaco (AIFA) is the primary authority for pharmaceuticals, operating under Legislative Decree 219/2006, which transposed EU Directive 2001/83/EC into national law. Pharmaceuticals follow EU-level pathways through the European Medicines Agency (EMA) for centralized procedures, or national and mutual recognition procedures coordinated by AIFA for decentralized approvals. Medical devices are regulated in accordance with EU Regulation 2017/745 (MDR) and EU Regulation 2017/746 (IVDR), with the Ministero della Salute maintaining the national device registry (Banca Dati e Repertorio dei Dispositivi Medici, RDM). Digital health solutions, including software as a medical device (SaMD), are increasingly subject to MDR classification rules, with guidance issued jointly by the Ministero della Salute and AIFA.

All pharmaceutical submissions to AIFA must follow the Common Technical Document (CTD) format as required by EU standards, and a local EU-based qualified person or legal representative is mandatory for non-EU manufacturers. Italy has implemented EU Joint Clinical Assessments under Regulation 2021/2282 on Health Technology Assessment, which came into force progressively from January 2025 and affects relative effectiveness evaluations. Recent reforms include the revision of AIFA's internal governance structure under Law 11 January 2018, n. 3, streamlining price and reimbursement negotiations and introducing managed entry agreements (MEAs) more systematically. Post-market surveillance obligations have been reinforced for medical devices under MDR and IVDR transition timelines, with Italy maintaining active Notified Body oversight through entities such as IMQ and ITALCERT.

Public procurement of health products in Italy is structured across national, regional, and local levels, reflecting the country's decentralized healthcare governance. The Servizio Sanitario Nazionale (SSN) is the overarching national health system, but procurement authority is largely devolved to the 21 regional health authorities (Regioni and Province Autonome), each managing their own budget and purchasing strategies. At the national level, Consip S.p.A., the central purchasing body of the Italian state, operates national framework agreements and tenders for health commodities on behalf of public entities. Regional aggregators, known as Soggetti Aggregatori, coordinate tenders at a regional or multi-regional scale, and participation in these aggregated procedures is mandatory for healthcare facilities above defined expenditure thresholds under Law 135/2012 and subsequent updates. The Agenzia Nazionale per i Servizi Sanitari Regionali (Agenas) provides technical support and benchmarking for procurement decisions across regions.

The private healthcare market in Italy is significant, encompassing private hospitals, accredited private clinics (case di cura), and out-of-pocket consumer spending on diagnostics, devices, and wellness products. Private procurement follows standard commercial channels and is not subject to public tender obligations. Italy does not rely materially on donor-funded procurement mechanisms such as UNICEF supply division, the Global Fund, Gavi, or USAID, as it is a high-income country and a net contributor to such programs. However, Italian public entities may participate in joint EU procurement initiatives, such as the EU Joint Procurement Agreement for medical countermeasures, coordinated by the European Commission. Local manufacturing preference policies are not formally codified in Italian procurement law, though European-origin production may carry practical advantages under EU public procurement principles, and recent EU strategic autonomy initiatives have encouraged member states to support domestic and European supply chain resilience for critical health products.