Italian Medicines Agency

Italian Medicines Agency (Agenzia Italiana del Farmaco, commonly known as AIFA) is the national authority responsible for drug regulation in Italy. It is a governmental agency that operates under the supervision of the Ministry of Health.

History

The Italian Medicines Agency was established in 2004, replacing the previous Italian Drug Agency (Agenzia Italiana del Farmaco). The agency was created to centralize the responsibilities of various other health and pharmaceutical bodies, and to provide a single point of contact for pharmaceutical companies.

Functions

The main functions of the Italian Medicines Agency include the regulation of pharmaceuticals, the authorization of new drugs, the monitoring of drug safety, and the promotion of research and development in the pharmaceutical sector. The agency is also responsible for setting the prices of medicines and for the reimbursement of prescription drugs.

Structure

The Italian Medicines Agency is headed by a Director General, who is appointed by the Minister of Health. The agency is divided into several departments, each responsible for a specific area of drug regulation. These include the Department of Medicines Evaluation, the Department of Pharmacovigilance, and the Department of Pharmaceutical Policy and Planning.

Activities

The Italian Medicines Agency carries out a wide range of activities related to drug regulation. These include the evaluation of new drugs, the monitoring of drug safety, the regulation of clinical trials, and the promotion of research and development in the pharmaceutical sector. The agency also plays a key role in the setting of drug prices and in the reimbursement of prescription drugs.

See also

• European Medicines Agency
• Food and Drug Administration
• Pharmacovigilance

External links

• Official website (in Italian)