Committees

The scientific authority and autonomy of the AIFA is supported by the activities of 4 Technical Scientific Committees consisting of experts of well established experience.

• Technical Scientific Committee: it assesses the national and European marketing authorisation applications, it delivers a consultative opinion on them and provides classification for reimbursement; the CTS takes over the tasks formerly attributed to the National Drug Evaluation Board (CUF, Commissione Unica del Farmaco) at the Ministry of Health.

• Prices and Reimbursement Committee (CPR, Comitato Prezzi e Rimborso): it carries out the activity of negotiation with pharmaceutical companies for the setting of prices of medicinal products reimbursed by the National Health Service according to transparent methods, timelines and procedures established by the Interministerial Committee for Economic Planning (Comitato Interministeriale per la Programmazione Economia – CIPE) deliberation of 1st February 2001.

• Agency-Regional Authorities Co-ordination Centre: it ensures a close collaboration between the Agency and the Regional Authorities. It analyses the trend and the factors in drug expenditure at national and regional level, it coordinates information flows on medicinal products, promotes generics and defines proposals for drug advertisement and information, Pharmacovigilance and Clinical Trials.

• Committee for the Promotion of Research and Development (R&D) (Commissione per la Promozione della Ricerca e Sviluppo): it promotes public and translational scientific research in the strategic sectors of healthcare, it fosters private investments on the national territory, it proposes criteria for a premium pricing for innovative medicinal products, it promotes the integration of different bodies and clinical research projects at national level.

Moreover, AIFA draws on a list of well known experiencedexperts for the activities of Sub-committees and Working Groups, for the assessment of European registration procedures and for a valuable participation to the activities of the European Medicines Agency (EMA) and more general at international level.