AIFA regulatory overhaul
Insider Insights

Overhaul of AIFA regulations marks milestone in Italian pharmaceutical landscape


A major reorganization at the Italian Medicines Agency (AIFA) took effect on January 30th, as announced in the Journal of Official Gazette. AIFA’s regulatory overhaul aims to enhance efficiency, streamline operations, and expedite drug approval processes, ensuring swift access to medical innovations for the Italian population.

The restructuring involves the establishment of the “Scientific and Economic Commission for Medicines,” replacing both The Technical and Scientific Committee (CTS) and the Pricing and Reimbursement Committee (CPR). Consequently, the number of members involved in drug assessment will be reduced from twenty to ten in the new commission.

The ministerial decree introduces modifications to the rules governing AIFA’s structure and operation. Notably, the position of Director General is eliminated, and the president becomes the official legal representative. The Minister of Health will appoint the Technical Scientific Director and the Administrative Director, considering input from the regions. The board of directors will now consist of the president and four members appointed by various entities, including the Minister of Health and the Minister of Economy and Finance.

What does this overhaul mean for stakeholders?

The updated AIFA regulation is a significant milestone for Italy’s pharmaceutical landscape. Stakeholders in the industry should anticipate potential challenges, such as the removal of the Director General role and the introduction of a new commission. The reduction in the number of members involved in drug assessment may pose obstacles to expediting the approval process. Proactive engagement with these changes will be crucial for adapting strategies and maintaining efficiency in bringing medicines to market.

Explore our resource library for other AIFA insights – click here


  1. Gazzetta Ufficiale.  
  1. Navlin Daily.  

Stay in the know, subscribe to our newsletter

Be the first to receive exclusive content on the latest from the pharmaceutical and market access sector.