AIFA

AIFA, or Agenzia Italiana del Farmaco, is Italy's national regulatory authority for medicines and for pharmacovigilance activities within the national health system. It operates under the Italian Ministry of Health and coordinates with regional authorities and EU institutions to ensure safe, effective, and accessible pharmaceutical products.

The agency was established in 2004 by reform legislation (Legislative Decree 193/2004) to centralize pharmaceutical regulation and pharmacovigilance. Based in Rome, AIFA administers the procedures for authorizing medicines and supervises post-marketing safety surveillance in Italy, aligning with European Union law and European Medicines Agency processes.

Core functions include granting and withdrawing marketing authorizations; evaluating medicines for safety, quality, and efficacy; coordinating pharmacovigilance, risk management, and adverse event reporting; monitoring pharmaceutical advertising; and determining pricing and reimbursement arrangements for the national health service. It also addresses drug shortages and maintains quality controls across manufacturing and distribution chains.

Governance is provided by a Board of Directors and a Director General, with scientific committees offering independent guidance. While performing regulatory duties, AIFA operates within the framework of national health policy and EU regulations, maintaining collaboration with the EMA and other member states to harmonize standards.

In common usage, AIFA refers to the Italian Medicines Agency; it should not be confused with similarly abbreviated organizations in other countries. The agency contributes to transparency in medicinal regulation and supports evidence-based decision-making in Italy's pharmaceutical sector.