AIFA reform
Insider Insights

AIFA reform set to move forward after receiving the green light by the State-Regions Conference


The restructuring of the Italian Medicines Agency (AIFA) has received the green light following approval by the State-Regions Conference last week. This significant development, originally slated for implementation in February 2023 but subject to multiple delays, marks a major overhaul in AIFA’s structure and functioning, arriving almost a year after the initial legislative proposal and two decades since AIFA’s establishment.

Key Restructuring Highlights:

  • Abolishment of the Director General’s Role: The President, jointly appointed by the Minister of Health and the regions, will now assume legal responsibility, overseeing the Board of Directors. The Board will consist of the President, two members selected by the regions, and two appointed by the Ministry of Health and the Ministry of Economy, respectively.
  • Appointment Process: The Minister of Health will appoint the Technical Scientific Director and the Administrative Director, considering input from the regions.
  • Merging Committees: The Technical and Scientific Committee (CTS) and the Pricing and Reimbursement Committee (CPR) will merge into the Scientific and Economic Commission (CSE), responsible for scientific assessments and pricing/reimbursement decisions.
  • Commission Composition: The new CSE will include the Technical Scientific Director, the President of the Superior Institute of Health (ISS) or a delegate, four members appointed by the Minister of Health, one member appointed by the Minister of Economy and Finance, and three members appointed by the State-Regions Conference.
  • Term Duration: With the exception of the Technical Scientific Director and the President of the National Health Institute (ISS), all members will have a three-year term, extendable only once.

According to Health Minister Orazio Schillaci, the revamped AIFA aims for increased efficiency and streamlined operations, facilitating quicker drug approval processes and ensuring prompt access to medical innovations for the Italian population.

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