New Italian regulation formalises CSE's unified medicine appraisal powers
The Italian Medicines Agency (Agenzia Italiana del Farmaco) (AIFA) has issued a Regulation on the organisation and functioning of the Scientific and Economic Committee for Medicines (Regolamento recante norme sull'organizzazione e sul funzionamento della Commissione scientifica ed economica del farmaco) (CSE Regulation) on 9 March 2026. This document codifies the powers of the single committee that replaced the previous dual-structure system. That system previously comprised the Technical-Scientific Advisory Commission (Commissione consultiva Tecnico-Scientifica) and the Price and Reimbursement Committee (Comitato Prezzi e Rimborso).
The framework centralises authority by merging clinical and financial oversight into a single ten-member body to eliminate procedural silos. Strategic criteria now explicitly include the sustainability of healthcare expenditure. The Scientific and Economic Committee for Medicines (Commissione scientifica ed economica del farmaco) (CSE) must operate within a framework that ensures compliance with pharmaceutical expenditure caps and programmed health needs. This formalises the link between therapeutic value and fiscal durability during price negotiations.
The regulation also aligns national procedures with European Union standards. The CSE will now issue opinions on Joint Clinical Assessments conducted under European Regulation 2282/2021 . Furthermore, AIFA has replaced fixed subcommittees with flexible thematic Working Groups (Gruppi di Lavoro) and a dedicated List of Experts (Elenco di esperti) . This internal reorganisation provides the committee with targeted technical support based on specific therapeutic domains.
Companies retain procedural rights, including the ability to request a single 30-minute hearing. They may also submit up to two counter-arguments if the committee issues a negative preliminary opinion. These measures take immediate effect. The transition to a unified body will likely reduce the total time taken for assessments by removing committee-to-committee transfers. However, the explicit focus on budgetary constraints will intensify the scrutiny of high-cost therapies.
Source: Italian Medicines Agency.
Link: Regolamento recante norme sull'organizzazione e sul funzionamento della Commissione scientifica ed economica del farmaco (Regulation on the organisation and functioning of the Scientific and Economic Committee for Medicines).
Date: 09 March 2026
