原料药是药品中元素杂质的重要来源。随着《中国药典》与国际人用药品注册技术协调会（ICH）协调转化工作的推进，作为《中国药典》2025年版实施的配套文件，国家药品监督管理局药品审评中心发布了“关于化学原料药中元素杂质评估与控制方面的共性问题”。从该共性问题的起草背景和技术方面考量的角度，通过原料药元素杂质评估与控制的基本考虑、具体流程和方法 2个方面，对该共性问题进行详细地阐述和说明，以增加业界对相关内容的理解，进一步促进原料药元素杂质评估与控制的规范性，从源头保障药品质量与患者安全。

Active pharmaceutical ingredients(APIs) are a significant source of elemental impurities in pharmaceutical products. With the ongoing efforts to harmonize and align the Chinese Pharmacopoeia with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use(ICH), the Center for Drug Evaluation of the National Medical Products Administration has issued a document titled “Common Issues in the Evaluation and Control of Elemental Impurities in Chemical Active Pharmaceutical Ingredients” as a supporting document for the implementation of the Chinese Pharmacopoeia 2025 Edition. This paper elaborates on the common issues from the perspectives of their drafting background and technical considerations, focusing on two key aspects: The fundamental considerations for the evaluation and control of elemental impurities in APIs, and the specific processes and methods involved. The aim is to enhance industry understanding of the relevant content, further promote the standardization of the evaluation and control of elemental impurities in APIs, and safeguard drug quality and patient safety from the source.

R927.1