基于ICH Q3D(R2)解读药品元素杂质研究的基本考虑

General considerations for the evaluation of elemental impurities in drug products based on ICH Q3D(R2)

元素杂质在药品中存在多种引入来源,应被控制在可接受的限度范围内。ICH于2022年正式发布了《Q3D(R2):元素杂质指导原则》,建立了药品中元素杂质研究的全球协调统一的指南。本文基于ICH Q3D(R2)梳理总结了元素杂质的分类及安全性评估原则,从审评角度分析了风险评估及控制策略建立过程中的基本考虑,就元素杂质研究中的重点环节和主要问题进行了探讨,以期基于风险、基于科学为药品中元素杂质的研究和控制提供参考。

Elemental impurities in drug products may arise from several sources,and should be controlled within acceptable limits.ICH has published the final version Q3D(R2)Guideline for Element Impurities in 2022,establishing a global harmonized guideline for the control of elemental impurities in new drug products.Based on ICH Q3D(R2),this article summarizes the classification and safety assessment principles of element impurities,proposes the general considerations in the risk assessment and control strategy from the perspective of CMC review,and discusses the key steps and main problems in the evaluation of elemental impurities,providing reference for the establishment of science⁃based and risk⁃based control strategy.