EudraVigilance

EudraVigilance is the system for managing and analysing information on suspected adverse reactions to medicines which have been authorised or being studied in clinical trials in the European Economic Area (EEA). The European Medicines Agency (EMA) operates the system on behalf of the European Union (EU) medicines regulatory network.

• electronic exchange of individual case safety reports (ICSRs) between EMA, national competent authorities (NCAs), marketing authorisation holders (MAHs) and sponsors of clinical trials in the EEA;
• early detection and evaluation of possible safety signals;
• better product information for medicines authorised in the EEA.

This electronic reporting is obligatory for marketing authorisation holders and sponsors of clinical trials.

The EudraVigilance system includes:

• a fully automated safety and message-processing mechanism using XML-based messaging;
• a large pharmacovigilance database with query and tracking functions.

It complies with the formats and standards of the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

From 30 June 2022, it will be mandatory to report side effects to EudraVigilance using a data format based on international standards set by the International Organization for Standardization (ISO). This will help increase the data quality and analytical capabilities in EudraVigilance.

Two ISO standards will apply:  

• the Individual Case Safety Report (ICSR) standard (ISO 27953-2:2011) and the modalities on how to implement this standard, as defined in the ICH E2B(R3) guideline;
• terminology on pharmaceutical dose forms and routes of administration (ISO/FDIS 11239:2012), in line with EMA's Referentials Management Service (RMS).

These standards are referred to in Commission Implementing Regulation (EU) No 520/2012 on the performance of pharmacovigilance activities, in articles 26(2)(a) and 25(1)(f) of chapter IV ('Use of terminology, formats and standards').

EMA's Management Board endorsed this approach on 19 December 2019, based on a recommendation by EMA's Pharmacovigilance Risk Assessment Committee (PRAC).

To help stakeholders prepare for this new requirement, EMA will update the EU ICSR Implementation Guide and provide face-to-face and online training, including webinars, to address technical and operational questions during 2020.

For more information, see:

• Management Board announcement of mandatory use of ISO ICSR format
• Data on medicines (ISO IDMP standards): Overview

More information on Eudravigilance and how to interact with the system

To continue to support the new EudraVigilance (human) system with enhanced features for the reporting and analysis of suspected adverse reactions, EMA's Pharmacovigilance Risk Assessment Committee (PRAC) has adopted the EudraVigilance operational plan for 2020 to 2022.

The plan describes key activities and developments that will take place between 2020 and 2022 and their impact on EudraVigilance and its stakeholders:

• EudraVigilance Operational Plan - Milestones 2020 to 2022
• EudraVigilance Operational Plan - Milestones 2018 to 2020

For more information on the new EudraVigilance (human) system, see EudraVigilance change management and EudraVigilance training.

EMA publishes data from EudraVigilance in the European database for suspected adverse drug reaction reports.

The EudraVigilance access policy governs the level of access different stakeholder groups have to adverse drug reactions reports.

EMA and national competent authorities are responsible for regularly reviewing and analysing EudraVigilance data to detect safety signals.

The Pharmacovigilance Risk Assessment Committee (PRAC) evaluates the safety signals detected in EudraVigilance and may recommend regulatory action as a result.

For more information on how EMA interprets information on reported cases of suspected adverse reactions, see:

• Guide on the interpretation of spontaneous case reports of suspected adverse reactions to medicines

EMA publishes annual reports to provide a summary of the EudraVigilance-related activities the Agency undertakes within the European medicines regulatory network and with stakeholders:

For more information on EMA activities, see Annual reports and work programmes.