我国生物医药产品的发展及监管

Development and regulation of biological products in China

介绍国内外生物医药产业的发展进程与现状,阐述我国生物医药的监管制度。从生物制品的注册审批、上市前的批签发、质量控制标准、及上市后的不良反应监测等制度作一综述,为我国生物医药及产品的发展与监管提供相应的借鉴参考。

The development and the status quo of domestic and foreign biopharmaceutical industries are introduced, and the supervision system of biological medicine in China is elaborated. The approval of biologics, the pre-marketing batch-release system for biological products, quality control standards, as well as the post-marketing adverse reaction monitoring system are reviewed, aiming to provide some references for the development and regulation of Chinese biopharmaceutical products.