Post-Marketing Surveillance

The mission of the Agency in pharmacovigilance is to ensure a positive risk/benefit ratio for all authorised drugs through the continuous monitoring of all safety information and adverse reactions.

These data originate from different sources: spontaneous reports of suspected adverse reactions (ADRs), trials, scientific literature, reports submitted by the pharmaceutical Companies, etc.

In particular, spontaneous ADRs are collected through the National Network of Pharmacovigilance (Rete Nazionale di Farmacovigilanza - RNF), an extensive network throughout the national territory that includes the Regional Authorities and the Autonomous Provinces of Trento and Bolzano, the Regional Centres of Pharmacovigilance, more than two hundred Local Health Authorities, about one hundred Hospitals, 43 Research Institutes and more than eight hundreds Pharmaceutical Companies and AIFA.

The RNF is also operating in connection with the European network for pharmacovigilance EudraVigilance that collects in a single database all data provided at national level by the EU countries.

AIFA also promotes active pharmacovigilance programs and studies with the aim of increasing knowledge on drugs, to better define their safety profile and to improve their safe use in medical practice.

AIFA is also responsible for intensive monitoring programs of:

• all newly marketed drugs
• medicines for which important changes of the marketing authorization have been approved
• use of all vaccines
• all orphan drugs

Contacts

	Pharmacovigilance Head of Office: Fernanda Ferrazin Phone: +39 06 59784209 Fax: +39 06 59784142 E-mail: f.ferrazin@aifa.gov.it
	Product Quality Head of Office: Marisa Delbò Tel: +39 06 59784406 Fax: +39 06 59784142 E-mail: m.delbo@aifa.gov.it