Based on a Pharmacovigilance Risk Assessment Committee (PRAC) recommendation, the EMA Management Board confirmed and announced the mandatory use of the ISO Individual Case Safety Report (ICSR) standard (ISO 27953-2:2011) based on the ICH E2B(R3) modalities as of 30 June 2022 for all reporting to EudraVigilance. Furthermore, the ISO terminology on pharmaceutical dose forms and routes of administration, (ISO 11239:2012), will also become mandatory at the same time.

This information day will highlight the necessary technical adaptation and implications for the use of the EDQM (European Directorate for the Quality of Medicines & HealthCare) terms to implement the pharmaceutical dose forms and routes of administration.

The COVID-19 pandemic and the authorisation of the vaccines against COVID-19 have a major impact on EudraVigilance and the database plays a crucial role on the signal detection and management activities for the vaccines. The impact on the database and the network together with the main signal management activities and achievements will be also outlined. 

An update of the existing ICH E2D (Post Approval Safety Data Management: Definitions and Standard for Expedited Reporting) guideline is proposed to clarify the management of post-approval safety information from new or increasingly used data sources. The revision of the E2D guideline will be an important opportunity to improve the generation of information related to safety and the problem statement together with the objectives will be explored.

Other aspects and milestones in the EudraVigilance operational workplan will be summarised.