Pioneering Drug Safety Since 2006
With nearly two decades of experience in pharmacovigilance, AB Cube has been at the forefront of drug safety innovation. In 2006, we launched SafetyEasy®, the first cloud-based pharmacovigilance software on the market—long before SaaS became the industry standard. Today, our SafetyEasy® Suite continues to lead the way, empowering life sciences organizations worldwide with a robust, AI-powered platform for compliant, efficient, and scalable pharmacovigilance operations.
Global Regulatory Readiness for Pharmacovigilance
Supporting EMA, FDA, Health Canada, and APAC Harmonization Initiatives
Navigating pharmacovigilance today means keeping pace with evolving global regulations, increasing data complexity, and rising expectations for proactive safety management. From the EU’s updated PV framework to FDA’s real-world evidence initiatives, Health Canada’s signal detection focus, and APAC’s digital transformation, regulatory landscapes are shifting fast.
SafetyEasy® Suite is built to meet these challenges head-on—offering pre-integrated compliance tools, automated workflows, and seamless updates that ensure your PV operations remain efficient, transparent, and future-proof. Whether you’re submitting ICSRs in Europe or managing post-market surveillance globally, our platform adapts to your needs and keeps pace with evolving regulatory expectations.
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EU Regulatory Landscape: Pharmacovigilance That Evolves With You
The European Commission adopted Implementing Regulation (EU) 2025/1466, amending Regulation 520/2012 to strengthen PV obligations for MAHs.
Key 2025 Updates:
- Only “major or critical” deviations must be documented in the Pharmacovigilance System Master File
- Subcontracting PV tasks now requires written consent from the sponsor and audit readiness
- MAHs must conduct risk-based audits covering all PV activities
- Mandatory use of EudraVigilance data for signal detection and risk evaluation
- PSURs must include updates on risk minimization measures
SafetyEasy® Suite: Built for EMA Compliance
- Automated ICSR generation and ISO E2B(R3)
- Integrated audit trail
- Built-in signal detection tools for proactive safety monitoring and regulatory alignment
- Continuous updates aligned with EMA and ISO standards
The new Addendum II to GVP Module VI on the masking of personal data in individual case safety reports submitted to EudraVigilance is published since July 25th 2025.
SafetyEasy Suite is already compliant with this requirement.
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U.S. FDA Updates: From Compliance to Real-World Safety / FDA Adverse Event Reporting System (FAERS) Electronic Submissions – E2B(R3) Standards
The FDA is expanding its focus on real-world evidence (RWE) and advanced analytics to enhance post-market safety surveillance.
The E2B(R3) standard will become mandatory on 01Apr2026 for both Postmarketing Safety Reporting & Premarketing Reporting (IND safety reports & IND-exempt BA/BE safety reports) ).
Key 2025 Trends:
- Integration of RWE into PV decision-making
- Emphasis on proactive risk management and early signal detection
- Continued support for E2B(R3) for combination products and biologics
SafetyEasy® Suite: Built for FDA Expectations
- Seamless MedWatch and E2B(R3) submissions
- Validated compliance with FDA CFR 21 Part 11 and GAMP®5
- Future-proof architecture for evolving FDA standards
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Health Canada: Strengthening Signal Detection & Transparency
Health Canada is aligning more closely with ICH guidelines and increasing scrutiny on signal detection methodologies and timely safety updates.
Key 2025 Focus Areas:
- Enhanced expectations for signal validation and documentation
- Greater transparency in periodic safety reporting
- Alignment with global standards for PV data formats
SafetyEasy® Suite: Built for Canadian Compliance
- Embeded PSUR and DSUR generation
- Support for Health Canada’s CIOMS or E2B (R2) reporting formats and timelines
- Full traceability and audit readiness
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Swissmedic: Electronic transmission of ICSRs in E2B(R3) format
Swissmedic published in September 2024 the Guidance for Industry on the electronic exchange of ICSRs in E2B (R3) format through B2B gateway (MU101_20_832)
SafetyEasy® Suite: Built for Swiss Compliance
Automated ICSR generation and E2B(R2/R3) reporting formats and timelines (especially 60 days for non-serious unexpected ADR(s))
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UK MHRA: Guidance Pharmacovigilance following agreement of the Windsor Framework
From 1 January 2025, all MAHs must send all UK ICSRs and serious non-UK ICSRs to the MHRA within current specified timeframes (15 days for serious reports, 90 days for non-serious reports).
SafetyEasy® Suite: Built for UK Compliance
Automated ICSR generation and E2B(R2/R3) reporting formats and timelines (especially 90 days for non-serious ADR(s))
The UK Data Protection Act 2018 sets out how personal data must be collected, handled and stored to protect people’s privacy. SafetyEasy Suite will soon enable its customers to comply with this UK requirement, as well as any other similar requirements in the World, wih the new ‘Custom Anonymization’ feature.
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APAC Region: Accelerating Digital Pharmacovigilance
Driven by the WHO Global Smart Pharmacovigilance Strategy, APAC regulators are investing in digital infrastructure and harmonized safety reporting.
Key 2025 Developments:
- India, Japan, and ASEAN countries expanding electronic PV systems
- Push for AI adoption and cross-border data sharing
- Harmonization of reporting standards across regional authorities
SafetyEasy® Suite: Built for APAC Expansion
- Multilingual, multi-format ICSR support
- Scalable architecture for regional deployments
- AI-ready workflows with explainable logic
- Seamless integration with national PV databases
- SafetyEasy® Vigilance expands compliance capabilities with R3 Korea in 2026.
Ready to Lead the Future of Drug Safety?
Join the companies transforming their PV operations with SafetyEasy® Suite.