EMA 2026 Reflection Paper on Non-Mutagenic Impurities
The EMA 2026 Reflection Paper on Non-Mutagenic Impurities marks a significant shift from threshold-based impurity qualification to a risk-based, exposure-driven framework. By prioritising New Approach Methodologies (NAMs), scientifically justified safety assessments and patient-relevant exposure evaluation, the guidance encourages more robust and efficient impurity assessments while reducing reliance on animal testing. This article highlights the key changes and what they mean for pharmaceutical manufacturers preparing regulatory submissions.
ICH Q3E Guideline: Extractables & Leachables
The draft ICH Q3E Guideline establishes a harmonized, risk-based framework for managing extractables and leachables (E&L) throughout the lifecycle of drug products. Covering study design, toxicological qualification, acceptable exposure limits, and lifecycle monitoring, Q3E provides manufacturers with a consistent approach to assessing E&L risks while supporting patient safety and regulatory compliance.