楼双凤 朱娟

    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。

    关键词 原料药 监管检查 风险分析 监管建议

    中图分类号：R951 文献标志码：C 文章编号：1006-1533(2024)03-0051-04

    引用本文 楼双凤， 朱娟. 当前原料药监管检查中存在的问题分析和监管建议[J]. 上海医药， 2024， 45(3)： 51-54.

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

    LOU Shuangfeng， ZHU Juan

    (Shanghai Center for Drug Evaluation and Inspection， Shanghai 201210， China)

    ABSTRACT 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.

    KEY WORDS APIs； regulatory inspection； risk analysis； regulatory recommendation

    我国是原料药生产与出口大国，近几年受全球医药产业链的影响 ......