药品中亚硝胺类杂质监管与检验技术研究进展

Advance of nitrosamine impurity inspection technology and drug administration

遗传毒性物质亚硝胺类杂质是近年来化学药品质量控制重点关注和检验指标之一。对比分析中国、欧盟、美国等药品监管机构对亚硝胺杂质的监管策略,分析各药品监管部门的监管机构的亚硝胺杂质检验技术研究与应用进展,提出应加强亚硝胺杂质来源的监管科学研究、完善基于风险评估的监管策略、强化监管机构间监管策略和标准的协调、加快检验技术开发和利用好抽样检验监管手段保障药品供应链安全,为做好我国化学药品质量控制提供参考。

Genotoxic substances-nitrosamine impurity are one of the key inspection indicators for chemical drug quality control in recent years.The China,European and USA drug regulatory authorities present supervision strategies of nitrosamine impurities were studied,and the research advance of nitrosamine impurity inspection technology in each drug administration authority was analyzed.It was put forward that the regulatory scientific research on nitrosamine impurities must be strengthened,regulatory strategies based on risk assessment should be improved,regulatory strategies and standards coordination among drug regulatory authorities was supposed to be strengthened,the development of inspection technology ought to be accelerated,drug sampling and testing methods should be utilized to ensure the security of the pharmaceutical supply chain,so as to provide reference for chemical drug quality control in China.