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EMA Guidance: Chemistry of Active Substances and GMP for Additive Manufacturing (3DP)
The European Medicines Agency (EMA) has introduced two significant guidance updates in 2026, focusing on active substance chemistry requirements and the emerging use of additive manufacturing (3D printing) in pharmaceuticals . These updates aim to strengthen quality, control strategies, and innovation , while ensuring that pharmaceutical development and manufacturing remain scientifically robust and patient-focused. Guidance: Chemistry of Active Substances Scope and Regulato
Sharan Murugan
Mar 294 min read