Endocrine disruptors under REACH and CLP in 2026
Does REACH require endocrine disruptor testing? Learn how endocrine disruptors are regulated under REACH and CLP, the role of OECD Guidance Document 150, ECHA expectations, and what future REACH revisions may mean for companies.
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.