Organization

The managementof AIFA is structured as follows:

• The Director-General, Luca Pani
• The Board, chaired by Sergio Pecorelli, and consists of four Directors: Gloria Saccani Jotti, Giovanni Bissoni, Romano Colozzi, Claudio De Vincenti;
• The Board of Auditors, consisting of the President, Mario Basili, and two members, Sergio Galimberti and Antonio Menetto.

 The Agency is structured into five technical-scientific functional departiments and one administrative area:

• Pre Authorization: it is competent for the activities related to clinical trials of medicines, inspections of Good Clinical Practice, promotion of independent research funded by AIFA;

• Registration: it manages the registration process of medicinal products for human use, according to official regulations at national and European level (Mutual Recognition, Decentralized Procedure); it also deals with the evaluation of the dossier in the pre-registration process managed by CHMP and provides support for registration procedures in which Italy is involved as Rapporteur or Co-Rapporteur;

• Post-Marketing Surveillance: it is responsible for drugs safety after their commercialization; it handles reports of "rapid alert" regarding quality defects and related withdrawals and suspensions of lots; it provides information and training addressed to healthcare professionals;

• Pharmaceutical Strategy and Policy: it is responsible for determining the price of medicines reimbursed by the National Health Service through the negotiation with pharmaceutical companies; it ensures the monitoring of pharmaceutical expenditure at national and regional level through the Drug Consumption Monitoring Centre (Osmed); it also conducts studies in order to know the national and international scenario in the field of pharmaceutical policy and to suggest new models and procedures to foster the development of the sector;

• Inspections and certification: it is competent for control activities and issuing of permits for the production of medicines, and inspection of Good Manufacturing Practice (GMP), production of medicines, medicinal gases and raw materials;

• Administrative Affairs: it ensures the unity and integrity of administrative, legal, regulatory and business affairs of the AIFA.

Furthermore, the Agency is supported by the following offices:

• The Press and Communication Office

• The Bureau.

Finally, the following offices with staff functions provide technical and secretariat support to the activities of the General Directorate and of the above mentioned functional areas:

• International Relations
• Quality Assurance
• Performance and Management Control 
• Information and Communication Technology.