Following the publication of the Regulation governing the organization and functioning of the Scientific and Economic Commission (CSE), adopted by the Board of Directors of the Italian Medicines Agency (AIFA) through Resolution No. 89 of 15 December 2025 and approved by the Minister of Health in agreement with the Minister of Economy and Finance and the Minister for Public Administration, the Italian Medicines Agency has defined the new operational structure of the Commission.
The Regulation establishes the central role of the CSE within AIFA’s renewed governance framework, defining its composition, competencies, and operational procedures. In particular, the Commission is assigned key functions in the evaluation of medicinal products, including the assessment of therapeutic value, support for pricing and reimbursement processes, and the classification of innovative medicines within the National Health Service.
The document also sets out the guiding principles of the CSE’s activities, including ensuring patient access to therapies, promoting the appropriate use of medicines, and maintaining the economic sustainability of the system, while also regulating the procedural aspects related to the conduct of meetings and decision-making processes.
In this context, SCF has developed a dedicated briefing that provides an overview of the structure and functioning of the CSE: CSE Regulation
