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The latest updates from SPORVIGILANCE
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Featured
News.
Featured news from SPORVIGILANCE, global IDMP developments, and the latest regulatory authority updates.
SPORVIGILANCE strengthens independent quality assurance for PMS-facing data
4th June 2026
SPORVIGILANCE is expanding the role of regulatory data validation by acting as an independent quality layer over exported product data, helping organisations assess PMS-facing information without connecting directly into their RIM systems.
By validating controlled exports against PMS business rules, SPOR reference data, and conditional field logic, the platform supports a more objective review of business correctness. This gives regulatory teams clearer evidence for migration QA, remediation planning, and ongoing governance before data is used in submission workflows.
SPORVIGILANCE introduces the first end-to-end SPOR governance platform
6th February 2026
SPORVIGILANCE is positioning PMS business rule validation at the centre of SPOR governance, becoming the first platform to bring full PMS rule logic, conditional field orchestration, SPOR reference data checks, and multi-product readiness dashboards into one unified validation layer.
The development marks a step forward for regulatory data quality, giving teams a stronger way to evidence business correctness before data moves into PMS-facing submissions. By combining rule-driven validation with field-specific remediation guidance, SPORVIGILANCE supports regulatory teams managing PMS readiness, RIM migrations, and ongoing submission confidence.
PMS data submission deadlines for marketing authorisation holders
16th September 2025
• Enrichment of structured manufacturer data and pack size for non-centrally authorised products (non-CAPs) featuring on the Union list of critical medicines by using the PMS product user interface (PUI) and application programming interface (API) - JUNE 2026
• Enrichment of structured manufacturer data for all other non-CAPs on the company’s portfolio using PMS PUI and API - DECEMBER 2026
• Enrichment of pack sizes for all other non-CAPs on the company’s portfolio using XEVMPD and structured pack sizes using PMS PUI and API - June 2027
Write PMS API Implementation Guide publication
27th January 2025
The Write PMS API Implementation Guide (IG) to support the PMS enrichment process is now available on the EMA PMS Webpage. This comprehensive FHIR-based resource supports developers and stakeholders in adopting healthcare data standards, ensuring efficient and secure data exchange.
Successful ePI pilot paves the way for ePI implementation
27th January 2025
The much-anticipated ePI Pilot Report makes recommendations and outlines the critical development efforts required to integrate electronic Product Information (ePI) into EU regulatory procedures. Its publication marks a significant milestone in EMA’s mission to deliver harmonised ePI, ensuring timely and accurate electronic medicines information for patients and healthcare professionals across Europe.
Funded by EU4Health, the ePI pilot was carried out over the past year by the EMA in collaboration with national authorities from the Netherlands, Spain, Denmark, and Sweden. Together, they successfully published 23 ePIs derived from actual regulatory processes.
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