The launch of the new and improved EudraVigilance system is due to happen on Wednesday 22nd November 2017. With this date fast approaching, the EMA have begun to perform the final preparations and last minute tasks.
The new system was developed and bought about by the 2012 EU pharmacovigilance legislation which promises to improve safety monitoring and make adverse event reporting more efficient. In order to begin use of the new system, a mass transfer of 11 million individual case safety reports (ICSRs) will need to take place from the old system to the new. Because of this, some functionalities of EudraVigilance will be completely or partially disabled for a period of 10 days (8 – 21 November).
Electronic submissions of data for medicines (article 57) and electronic reporting of ICSRs and SUSARs will be disrupted. However, the EMA, along with PRAC and CTFG, have put together a EudraVigilance go-live plan which provides guidance on alternative reporting arrangements in order to prevent a back-log mounting and to ensure that important vigilance processes are continued during the downtime.
To read further on the EudraVigilance go-live plan, click here.