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.
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EVDAS - The Analytics Extension
The EudraVigilance Data Analysis System (EVDAS) is a game-changer for proactive signal detection. It offers MAHs access to the same analytical tools used by EMA and NCAs, allowing them to:
- View aggregate data across spontaneous reports
- Perform signal validation activities
- Generate Line Listings and Summary Tabulations
- Access Standardized MedDRA Queries (SMQs)
- Use statistical tools like PRR (Proportional Reporting Ratio)
Tier 1 products (centrally authorised products) require regular monitoring of EVDAS outputs to comply with GVP Module IX. MAHs must perform signal detection at least every month and document their assessments.
However, interpreting EVDAS data isn’t as straightforward as running reports. MAHs must validate and contextualise findings, correlate them with global safety data, and maintain traceability for inspections. This requires not only analytical competence but also regulatory intelligence.
SPOR - The Data Backbone Supporting Regulatory Systems
While EudraVigilance and EVDAS handle the “what happened” and “why,” SPOR handles the “who, what, where” of regulatory data. It is a set of four interrelated databases:
- Substance Management Services (SMS) – capturing chemical and biological substance data
- Product Management Services (PMS) – managing product and authorisation details
- Organisation Management Services (OMS) – ensuring consistency in organization details (such as MAHs, sponsors)
- Referential Management Services (RMS) – storing reference data like country codes, units of measurement, etc.
SPOR is foundational to IDMP (Identification of Medicinal Products) implementation and is critical for regulatory submissions, pharmacovigilance activities, and clinical trial disclosures. By standardising data formats and hierarchies, it enables seamless data exchange across systems like EudraVigilance, CTIS, and xEVMPD.
In 2025, MAHs are increasingly required to ensure their organisation and product data is SPOR-compliant. Inaccurate or unaligned SPOR entries can delay submissions, compromise EVDAS searches, and trigger regulatory scrutiny.
Why This Evolution Matters to MAHs
The move from isolated safety reporting to interconnected databases means that regulators now see your data as one continuous digital footprint from adverse event to marketing authorisation to signal detection. This makes accuracy, traceability, and real-time compliance non-negotiable.
Key implications for MAHs include:
- Responsibility to monitor EVDAS regularly and document decisions even when no signals are detected.
- Harmonisation of global and EU-specific safety strategies, particularly in signal validation and signal management.
- Ensuring data alignment across SPOR and xEVMPD, especially in the context of product lifecycle changes.
- Preparing for data-centric audits, where system readiness and metadata integrity matter as much as medical judgment.
What Lies Ahead?
The upcoming years are set to witness full IDMP implementation, deeper integration between SPOR and CTIS, and more sophisticated AI-driven signal analytics within EVDAS. MAHs needs to view compliance not as a series of checklists but as an ecosystem that thrives on consistency, collaboration, and technological adaptation.
EMA has also signaled its intent to make regulatory data more transparent, increasing public access to safety profiles and decision-making rationales. This will place greater emphasis on the quality and interpretability of pharmacovigilance outputs.
How Can DDReg Help?
At DDReg, we go beyond basic compliance to build end-to-end pharmacovigilance frameworks that align with evolving EU standards. Our team supports EVDAS signal detection and evaluation, SPOR data management, EudraVigilance submission readiness, PV system audits, Training programs.
With our cross-functional expertise in regulatory affairs, data standards, and pharmacovigilance operations, DDReg enables MAHs to navigate the EU’s safety reporting evolution with confidence, compliance, and clarity.
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