遺傳毒性物質亞硝胺類雜質是近年來化學藥品質量控制重點關注和檢驗指標之一。對比分析中國、歐盟、美國等藥品監(jiān)管機構對亞硝胺雜質的監(jiān)管策略，分析各藥品監(jiān)管部門的監(jiān)管機構的亞硝胺雜質檢驗技術研究與應用進展，提出應加強亞硝胺雜質來源的監(jiān)管科學研究、完善基于風險評估的監(jiān)管策略、強化監(jiān)管機構間監(jiān)管策略和標準的協(xié)調、加快檢驗技術開發(fā)和利用好抽樣檢驗監(jiān)管手段保障藥品供應鏈安全，為做好我國化學藥品質量控制提供參考。

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.

R927.11

國家重點研發(fā)計劃課題（2018YFC0830802）；中國食品藥品檢定研究院中青年發(fā)展研究基金資助項目（2022G1）