On November 22nd, 2017 EMA will launch a new and improved version of EudraVigilance.
This will have impact also to the Italian pharmacovigilance network (Rete Nazionale di Farmacovigilanza, RNF). In fact, starting from that date, MAHs will no longer submit spontaneous serious and non-serious Italian ICSRs (including reports from literature) to the RNF but directly through EudraVigilance. Italian ICSRs entered in EudraVigilance will be then re-routed to the RNF, two times a day. Consumers and healthcare professionals will continue to send to the RNF the ADRs. These cases will be then transmitted to EudraVigilance, every night.
The new version of EudraVigilance will allow MAHs to download Italian ICSRs coming from the RNF. However not all the information relevant to Italian cases will be available in EudraVigilance, furthermore all unstructured data will remain in local language.
According to the information provided by AIFA during a recent Workshop, the registration to the RNF will remain mandatory for MAHs. In addition it is highly recommended that MAHs will continue to monitor RNF, in particular for the management of follow-up requests and for the access to all the information relevant to cases (e.g.: attachments such as clinical reports and other documents uploaded in the RNF, the name of the responsible persons of pharmacovigilance of the local healthcare facilities who entered the ICSR in the RNF, etc.).
Further clarifications from AIFA on this topic are expected.