Italian Medicines Agency Agenzia Italiana del Farmaco

Pharmacovigilance signals

Pharmacovigilance Signals

All reports of suspected adverse reactions collected through the reporting system are continuously monitored in order to identify any warning signals and implement appropriate risk minimisation measures.

A “signal” is an information that suggests (mainly a hypothesis) a new potentially causal association, or a new aspect of a known association, between a medicinal product and an event or set of related events, which is judged to be of sufficient likelihood to justify further investigation. If a signal is confirmed, appropriate regulatory action can be taken to prevent or minimise the risks relating to the medicinal products and make their use safer and safer.

The above-mentioned process, known as Signal Management, is a rather complex process involving several actors such as the European Medicines Agency, the Regulatory Authorities of the Member States (including the Italian Medicines Agency) and marketing authorisation holders (pharmaceutical companies), who have the obligation to continuously monitor the data recorded in the European database of suspected adverse reactions (Eudravigilance), to cooperate for the purpose of data monitoring and to mutually share information on new risks or any change in known risks and in the benefit/risk balance.

Once a pharmacovigilance signal is detected, it is assessed collectively at European level with the involvement of the European Medicines Agency Pharmacovigilance Risk Assessment Committee (PRAC) responsible for assessing and monitoring the safety of human medicines.

At the end of the assessment process, the PRAC provides recommendations which are regularly published on the European Medicines Agency website (access from related links)

AIFA avails itself of the collaboration of Regional Pharmacovigilance Centres for the evaluation of signals according to defined and shared operating procedures.

PRAC evaluations

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