Safety Reporting in the EU - EudraVigilance to EVDAS & SPOR

 

Safety Reporting in the EU

With safety reporting in the European Union (EU) entering a new era of digital integration and oversight, pharmacovigilance systems have become more connected, data-driven, and strategically central to regulatory compliance. What once revolved around manual case handling and isolated national databases has transformed into a highly interconnected pharmacovigilance network. This shift is not only redefining how Marketing Authorisation Holders (MAHs) manage Individual Case Safety Reports (ICSRs), but it’s also reshaping their overall safety strategy.

The regulatory landscape has gone far beyond the central EudraVigilance system. Tools like EVDAS (EudraVigilance Data Analysis System) and SPOR (Substance, Product, Organisation, and Referential data services) have become central to pharmacovigilance compliance. However, with increased automation, transparency, and interconnectivity come greater complexity and responsibility. This blog unpacks the evolution of EU safety reporting and explores what it really means for MAHs today.

EudraVigilance — The Backbone of EU Safety Reporting

The EudraVigilance database, operated by the European Medicines Agency (EMA), has served as the central hub for ICSRs since 2001. It facilitates electronic reporting of suspected adverse reactions for medicinal products authorized in the EU. With the implementation of the Good Pharmacovigilance Practices (GVP) Module VI and the 2017 EudraVigilance milestone update, MAHs must submit all serious and non-serious ICSRs occurring within the EEA directly to EudraVigilance within stipulated timelines-15 days for serious cases and 90 days for non-serious ones. The simplified reporting path reduced the need for parallel reporting to National Competent Authorities (NCAs), streamlining operations. However, EudraVigilance is not a standalone solution. As the volume of safety data grew, so did the demand for better analysis tools and structured regulatory data handling.

Read more about Safety Reporting Processes in the European Union: Evolving Safety Reporting in the EU: Beyond EudraVigilance to EVDAS & SPOR — DDReg pharma

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