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AIFA - THE ITALIAN MEDICINES AGENCY

The Italian Medicines Agency (Agenzia Italiana del farmaco - AIFA) is, since 2004, 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 of pharmaceutical industries and distributors.

The mission:

  • promoting good health through medicines
  • setting fair pharmaceutical policies and assure their consistent application nationwide
  • managing the value and cost of medicines
  • promoting pharmaceutical research and development
     

In this framework, the Agency:

  • 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, pharamceutical companies and distributors
  • promotes pharmaceutical culture and knowledge
     

AIFA pays particular attention to fake medicines issue. AIFA Counterfeit Prevention Unit leads many international project, as the chair of two Council of Europe (CoE) - EDQM Committees (CD-P-P and CMED).
 

The main activities areas are: 

  • development of  IT Intelligence project (e.g. internet monitoring for the individuation of illegal e-pharmacies)
  • development of regulatory proposal; the Unit has actively partecipated to many international initiatives and in the definition of two regulatory instruments as MediCrime Convention (CoE) and European Directive 2011/62
  • intersectorial training session (customs, polices forces, health authorities), in order to ensure the continuous update on recent cases
  • communication about the risks posed by falsified product, with the aim of raising awareness