Europe – EudraVigilance Operational Plan

EudraVigilance is the central pillar for pharmacovigilance activities in the European Economic Area (EEA). In February and April 2017, the enhanced EudraVigilance system successfully passed an independent audit in accordance with Article 24 of Regulation (EC) 726/2004. The EMA Management Board confirmed on 22 May 2017 that the full functionality of the EudraVigilance database had been achieved and the system met the defined functional specifications1. The new EudraVigilance system was launched on 22 November 2017, providing enhanced functionalities to national Competent Authorities (NCAs), the European Medicines Agency (EMA), the Commission and marketing
authorisation holders (MAHs) for effective reporting and monitoring of suspected adverse reactions and detection of risks related to the safety of medicines, thus contributing to the protection and promotion of public health. Furthermore, EudraVigilance facilitates the safety reporting of suspected unexpected serious adverse reactions (SUSARs) to investigational medicinal products occurring during clinical trials…