Italian Medicines Agency Agenzia Italiana del Farmaco



Pharmacovigilance is the set of activities aimed at conributing to the protection of public health. They are activities directed toward identifying, assessing, understanding and preventing adverse effects or any other problem related to the use of medicines, in order to ensure a favourable benefit/risk ratio for the population.

Data on medicine safety can be derived from multiple sources: Reports of suspected adverse reactions (spontaneous and non-spontaneous), clinical trials, scientific literature, reports from pharmaceutical industries, etc.

AIFA promotes active pharmacovigilance programmes and studies with the aim of increasing knowledge on medicines and better defining the safety profile in relation to their use, improving how they are used, establishing a safety profile that best corresponds to clinical practice, and more realistically describing the characteristics of patients undergoing treatment.

Reference/EU legislation

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