EudraVigilance is the central pillar for pharmacovigilance activities in the European Economic Area (EEA). In February and April 2017, the new 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 specifications
The new EudraVigilance system was launched on 22 November 2017, providing enhanced functionalities to national Competent Authorities (NCAs), EMA 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.
This operational plan has been prepared upon request by the Pharmacovigilance Risk Assessment Committee (PRAC), which is overseeing the operation of EudraVigilance. The operational plan describes
key activities and developments that will impact on or relate to EudraVigilance and its stakeholders during the next three years from 2018 to 2020.
The plan’s objective is to outline technical as well as operational activities with anticipated timelines and to highlight how EudraVigilance and the stakeholders that interact with the system will be affected.
This should facilitate planning by the Agency, which is operating EudraVigilance on behalf of the network and ensure timely preparedness of NCAs, MAHs, commercial and non-commercial sponsors of clinical trials and the WHO Uppsala Monitoring Centre.
The goal is to ensure sustainability of EudraVigilance and associated activities in support of the EU pharmacovigilance activities and the protection of public health.
In addition, the interaction with stakeholders as part of training and support as well as communication and engagement are covered to ensure that a platform for learning, cooperation, dialogue and alignment throughout the evolution and operation of EudraVigilance system is provided for.
This plan will be updated regularly as regards timelines and new activities/developments.