A quick note to inform you that the EMA launched its new improved version of the Eudravigilance system on 22 November 2017. It is now mandatory to report suspected ADRs through the new system.
The new system has been designed to offer “enhanced features for the reporting and analysis of suspected adverse reactions, to support stronger safety monitoring of medicines and a more efficient reporting process for stakeholders”. It will be interesting to monitor whether the system delivers these improvements, as time passes, and users become more familiar with it.
For further information, please refer to our previous blog and the attached guidance.