The bodies of the Agency are the President, the Board of Directors, and the Board of Auditors.

President

The President is the legal representative of the Agency and is responsible for carrying out the tasks and exercising the functions set out in Article 7 of the Decree of the Minister of Health no. 245 of 20 September 2004, as last amended by the Decree of the Minister of Health no. 3 of 8 January 2024. 

The President is appointed by decree of the Minister of Health, in agreement with the Permanent Conference for Relations between the State, the Regions and the Autonomous Provinces of Trento and Bolzano, after consulting the Minister of Economy and Finance.   

The President of AIFA is Robert Giovanni Nisticò

Board of Directors

The Board of Directors consists of the President and four members, one designated by the Minister of Health, one by the Minister of Economy and Finance, and two by the Permanent Conference for Relations between the State, the Regions and the Autonomous Provinces of Trento and Bolzano. 

Robert Giovanni Nisticò - President 

Francesco Fera - Board Member 

Emanuele Monti - Board Member 

Angelo Gratarola - Board Member 

Vito Montanaro - Board Member

Board of Auditors

The Board of Auditors is constituted in accordance with the provisions of Article 48, paragraph 4, of the founding law (Law No. 326 of November 24, 2003).

It is composed of the President, appointed by the Minister of Economy and Finance, a member designated by the Minister of Health, and one designated by the State-Regions Conference, serving a five-year term.

The Board of Auditors carries out control, including accounting, of the Agency's activities. It is convened by the President, also upon request of the members, whenever deemed necessary, and at least every quarter.

Roberto Nicolò - President

Davide Maggi - Member

Vincenzo Simone - Member

General Directorates

Administrative Director

The position of Administrative Director is conferred by decree of the Minister of Health, in consultation with the Minister of Economy and Finance and the Permanent Conference for Relations between the State, the Regions and the Autonomous Provinces of Trento and Bolzano. 

The Administrative Director carries out and directs the activities specified in Article 10 of the Decree of the Minister of Health no. 245 of 20 September 2004, as last amended by the Decree of the Minister of Health no. 3 of 8 January 2024, availing himself of the Divisions and Offices. 

In particular, the Administrative Director:

• shall prepare and forward to the President, for deliberation by the Board of Directors: 
  • the budget estimate and final balance sheet, as well as the three-year and annual activity   programmes of the Agency accompanied by the respective budget estimates and reporting documents; 
  • the outline of the internal rules necessary to ensure the functioning of the Agency; 
  • the total number of staff and the allocation of the relevant human, material and economic-financial resources among the functional divisions; 

• Stipulates contracts and agreements in line with the strategic directions set by the Board of Directors. 
• Sets, after consulting the Technical-Scientific Director for the competence profiles, the objectives of the functional divisions and management offices, establishes the levels of responsibility and implements the economic incentive methods for the achievement of the objectives and results. 
• Implements the distribution of human, material and financial resources among the general directorate offices. 
• Adopts administrative acts and measures and management acts necessary for the achievement of the Agency's objectives and exercises the related spending powers, with the possibility of specific delegation to the heads of the functional divisions and directorate offices. 
• Ahandles legal affairs and disputes, as well as activities related to the quality of procedures, secretarial functions of the collegiate bodies operating at the Agency and activities related to the Agency's information systems. 

The Administrative Director, in coordination with the Technical-Scientific Director: 

1. prepares the draft agreement referred to in Article 4, paragraph 3 of the Rules above and submits it to the President; 
2. prepares the periodic reports referred to in article 4, paragraph 2, letter d) of the Rules, for the approval by the Board of Directors for the subsequent transmission to the Minister of Health. 

The Administrative Director of AIFA is Giovanni Pavesi 

Technical-Scientific Director

The position of Technical-Scientific Director is conferred by decree of the Minister of Health, in consultation with the Minister of Economy and Finance and the Permanent Conference for Relations between the State, the Regions and the Autonomous Provinces of Trento and Bolzano. 

The Technical-Scientific Director performs the functions set forth in Article 10-bis of the Decree of the Minister of Health no. 245 of 20 September 2004, as last amended by the Decree of the Minister of Health no. 3 of 8 January 2024. 

In particular, the Technical-Scientific Director carries out and directs the technical-scientific activity of the Agency using the Divisions and Offices and: 

• a) implements the appropriate measures to ensure the functions referred to in Article 48, paragraph 5, letters a), b), g), h), i) and l), of Decree-Law no. 269 of 30 September 2003, converted by Law no. 326 of 24 November 2003; 
• b) formulates proposals for the purpose of drawing up the list referred to in Article 6, paragraph 3, letter i), of the Rules; 
• c) coordinates with the activities of the EMA. 

The Technical-Scientific Director also, in coordination with the Administrative Director, carries out activities specified in Article 10, paragraph 2-bis of the Rules. 

The Technical-Scientific Director of AIFA is Pierluigi Russo

The Board of Auditors is constituted in accordance with the provisions of Article 48, paragraph 4, letter c, Legislative Decree no. 269 of 30 September 2003, converted, with amendments, by Law no. 24 November 2003 (establishing law)

Massimo Zeppieri - President

Matteo Petrella - Member

Angelo Vittorio Sestito - Member

The Independent assessment body of the Italian Medicines Agency is composed as follows:

• Luca Del Bene - Chairperson
• Rosa Castriotta - Member
• Patrizia Colagiovanni - Member

The Body, which has received the favorable opinion by the Department of Public Administration, is assigned the tasks and functions provided for by Legislative Decree 27 October 2009, no. 150. It carries out the strategic control activities referred to in Article 6, paragraph 1, of Legislative Decree 30 July 1999, no. 286.

A permanent technical structure is established within the Body, aimed at measuring performance, corresponding to AIFA’s performance and management control unit.