摘 要 《药品生产质量管理规范(2010年修订)》生化药品附录的颁布、施行对生化药品生产企业提出了新的要求。本文就生化药品国内外监管法规进行对比分析，希望能为生化药品生产企业完善生产质量管理提供一定的帮助。

    关键词 生化药品 法规 指南

    中图分类号：R951 文献标志码：C 文章编号：1006-1533(2019)07-0016-03

    Comparative analysis of domestic and foreign regulations for biochemical drugs

    LIU Tao*， ZHU Jiaxian， SHI Lyuyan**

    (Shanghai Center for Drug Evaluation and Inspection， Shanghai 201203， China)

    ABSTRACT Many new requirements for biochemical drug manufacturers are listed in the new annex of Good Manufacturing Practice (2010 revision) for the production of biochemical drugs. The domestic and foreign regulations for the supervision of biochemical drugs were compared in this article so as to provide certain help for biochemical drug manufacturers to improve their quality management for the production of biochemical drugs.

    KEY WORDS biochemical drugs； regulations； guidelines

    我国目前施行的《药品生产质量管理规范(2010年修订)》(以下简称为“2010版GMP”)于2010年10月19日经卫生部部务会议审议通过并予以发布 ......