应对药品“N-亚硝基二甲胺杂质”事件监管措施分析  

Analysis of regulatory measures in response to“N-nitrosodimethylamineimpurity”pharmaceuticals incidents

作　　者：王立杰 翟铁伟 WANG Li-jie;ZHAI Tie-wei(Center for Food and Drug Inspection of National Medical Products Administration,Beijing 100044,China)

机构地区：[1]国家药品监督管理局食品药品审核查验中心,北京100044

出　　处：《中国新药杂志》2022年第12期1146-1150,共5页Chinese Journal of New Drugs

摘　　要：N-亚硝基二甲胺(NDMA)是一种亚硝胺类致癌物,世界卫生组织(WHO)国际癌症研究机构发布的致癌物质清单中将其列为2A类致癌物。近年来在多款药物中检出NDMA,为控制风险,各国药品监管机构采取了一系列应对措施。本文旨在通过回顾梳理各国药品监管机构在应对NDMA杂质危机中的措施,为此类问题的处理及类似问题的应对提供参考。N-nitrosodimethylamine(NDMA)is a nitrosamine carcinogen,which is listed as a 2 A carcinogen in the list of carcinogens issued by the World Health Organization(WHO)International Agency for Research on Cancer.In recent years,NDMA has been detected in a number of drugs.In order to control the risk,the drug regulatory agencies of various countries have adopted a series of countermeasures.This article aims to review and sort out the measures taken by the drug regulatory agencies in responding to the NDMA impurity crisis,and provide a reference for regulatory agencies to deal with the NMDA impurity problem and other similar issues.

关 键 词：N-亚硝基二甲胺 杂质 药品监管 

分 类 号：R95[医药卫生—药学]