The Ministry of Health (Ministero della Salute, MS) published the Approval of the regulation for the organisation and functioning of the Italian Medicines Agency (Approvazione del regolamento di organizzazione e funzionamento dell'Agenzia italiana del farmaco) on 9 March 2026. This decree provides the final legal basis for the structural overhaul of the Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA). While the shift to a unified committee was previously signaled, this publication triggers the formal 15-day window before the new operational rules become law.
This measure – which represents a structural reform – definitively dissolves the previous dual-committee system. The Scientific-Economic Commission (Commissione Scientifica ed Economica, CSE) now holds the combined powers of clinical appraisal and price negotiation. This consolidation shifts institutional power by removing the functional separation between medical benefit and fiscal impact. The decree specifies that the CSE will consist of ten members. These include the Technical-Scientific Director (Direttore Tecnico-Scientifico), who will attend meetings without voting rights to ensure continuity between assessment and final decision-making.
The regulation introduces specific quorum requirements to prevent administrative deadlock. Decisions now require a simple majority of members present. It also clarifies the role of the Board of Directors (Consiglio di Amministrazione, CdA) in overseeing the financial sustainability of CSE decisions. These data show that the state intends to use this streamlined structure to reduce the backlog of pending pricing dossiers.
The new arrangements enter into force on 24 March 2026. This date marks the deadline for transitioning all active negotiations to the new framework. Success now depends on the ability of the agency to manage the technical handover of existing files without disrupting market access timelines.
Source: Ministero della Salute
Link: Approvazione del regolamento di organizzazione e funzionamento dell'Agenzia italiana del farmaco (Approval of the regulation for the organisation and functioning of the Italian Medicines Agency)
Date: 9 March 2026
