当前原料药监管检查中存在的问题分析和监管建议  

Analysis of the problems and regulatory suggestions in the current supervision and inspection of active pharmaceutical ingredient

作　　者：楼双凤 朱娟 LOU Shuangfeng;ZHU Juan(Shanghai Center for Drug Evaluation and Inspection,Shanghai 201210,China)

机构地区：[1]上海药品审评核查中心,上海201210

出　　处：《上海医药》2024年第3期51-54,共4页Shanghai Medical & Pharmaceutical Journal

摘　　要：原料药直接影响到药品的质量,与药品的安全、有效关系密切。本文梳理了我国对化学原料药监管的法律法规要求,对当前原料药监管在注册检查、药品生产许可、上市后变更管理等方面存在的问题进行风险分析,同时提出了监管建议。Active pharmaceutical ingredients(APIs)can directly affect the quality of drugs,and are closely related to the safety and effectiveness of drugs.This paper reviews the legal and regulatory requirements for the current supervision of chemical APIs in China,analyzes the risk existing in the supervision of APIs in the registration inspection,drug production licensing,post-market change management and so on and puts forward regulatory proposals.

关 键 词：原料药 监管检查 风险分析 监管建议 

分 类 号：R951[医药卫生—药学]