Regulatory Blog

Regulatory authorities across the European Union continue to strengthen pharmacovigilance systems and data-driven regulatory decision-making. Two important EMA documents highlight these developments: the EU implementation strategy for the ICH E2D(R1) guideline on post-approval safety data and the Network Data Steering Group (NDSG) Workplan 2026–2028 on data and artificial intelligence in medicines regulation. Guidance: Network Data Steering Group Workplan 2026–2028: Data and

This blog summarizes two important regulatory guidances from the U.S. Food and Drug Administration (FDA) that support pharmacovigilance and real-world evidence generation: M14: General Principles for Planning, Designing, Analyzing, and Reporting Non-Interventional Studies E2D(R1): Post-approval Safety Data – Definitions and Standards for Management and Reporting of Individual Case Safety Reports Together, these guidances provide a framework for how pharmaceutical companies ge