原料药国际注册中基因毒性杂质的法规解读

遗传毒素是一类极富挑战性的杂质，并已被证明即便在低浓度条件下依然具有毒性。因此美国和欧盟的药品监管机构以及人用药品注册技术要求国际协调会（ICH）都特别指定了它们在原料药和成品药中的限量。通过解析原料药在美国和欧盟注册中涉及到的关于基因毒性杂质控制的法规，为中国制药企业提供相关技术指导以推动中国药品出口事业的增长。

Introduction to regulations for genotoxic impurities in API registration

Genotoxic toxin is a very challenging impurity, which has been proved to be toxic even at low level. Thus ICH and other competent authorities in US and EU have established limitation for genotoxic impurities in active pharmaceutical ingredients (API) and ifnished dosage form. The US and EU regulations concerned with genotoxic impurities are elaborated so as to provide some technical advices for Chinese drug manufacturers and make progress for the business of drug exportation.