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EMA Guidance: Implementation of ICH E2D(R1) for Post-Approval Safety Reporting and the EU Network Data & AI Strategy
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
Sharan Murugan
5 hours ago4 min read