AIFA is structured in six management departments (five scientific technical departments, namely Pre-Authorisation Department, Medicinal Products Authorisation Department, Post-Marketing Surveillance Department, Economic Strategy of Pharmaceutical Products Department, Inspection and Certification Department, plus an Administration Department) and cross-functional supporting structures, such as: the Chairperson’s Office, the External Relations Area, the Legal Area, the International Affairs Department, the ICT Department, the Performance and Management Control Office and the Quality Assurance Office.
2016 AIFA Rules and Procedures
The Director General is the legal representative of the Agency. S/he enjoys all management powers of the Agency and directs its activity, issuing the provisions which are not attributed to the other bodies of the Agency. S/he is responsible for the activities pursuant to paragraph 2 of Article 10 of Ministerial Decree 20 September 2004, no. 245.
AIFA's Interim Director General is Anna Rosa Marra.
The Board of Directors comprises the Chairperson, appointed by the Minister of Health in agreement with the State-Regions Conference, and four members, two of whom are appointed by the Minister of Health and two by the State-Regions Conference.
Giorgio Palù - Chairperson
Renato Bernardini - Director
Massimiliano Abbruzzese - Director
Davide Carlo Caparini - Director
Tiziano Carradori - Director
Board of Auditors
The Board of Auditors is established in compliance with the provisions of Article 48, paragraph 4, of Law No. 326 of 24/11/2003.
The Board is made up of the Chairperson, appointed by the Minister of Economy and Finance, by a member appointed by the Minister of Health and by one designated by the State-Regions Conference. The Board holds office for five years.
The Board of Auditors performs control, including accounting control, of the Agency's activities. It is convened by the Chairperson, as well as upon the members’ request, whenever deemed necessary and, in any case, at least every quarter.
Roberto Nicolò - Chairperson
Davide Maggi - Member
Vincenzo Simone - Member
Independent Assessment Body
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.