The Italian Medicines Agency

The Italian Medicines Agency (AIFA) is the national authority responsible for drugs regulation in Italy.

It is a public body operating autonomously, transparently and according to cost-effectiveness criteria, under the direction of the Ministry of Health and under the vigilance of the Ministry of Health and the Ministry of Economy.

It cooperates with the Regional Authorities, the National Institute of Health, Research Institutes, Patients’ Associations, Health Professionals, Scientific Associations the Pharmaceutical Industry and the Distributors.

The mission:

-       Promote good health through medicines

-       Set fair pharmaceutical policies and assure their consistent application nationwide

-       Manage the value and cost of medicines

-       Promote pharmaceutical research and development

 -      Demonstrate independence and leadership both at home and internationally.

More specifically, the Agency:

• guarantees access to medicines and their safe and appropriate use as means to protect public health;
• ensures unity of the national pharmaceutical system in agreement with the regional authorities;
• ensures innovation, efficiency and simplification of the marketing authorisation procedures, in order to grant rapid access to innovative drugs and to drugs used for rare diseases;
• provides drug expenditure governance in the framework of economic and financial viability and competitiveness of the pharmaceutical industry;
• encourages investments in research & development in Italy;
• enforces the relationship with the Agencies of other member states, the European Medicines Agency (EMA) and other international bodies;
• interacts with the community of patients’ associations, the scientific medical world, pharmaceutical companies and distributors;
• promotes pharmaceutical culture and knowledge.