随着国内外生物技术的蓬勃发展及高新技术领域的不断扩大,生物制品标准化工作的重要性及作用已得到各国药品管理当局的重视。我国生物制品标准化工作也在不断深入。本文根据近年来国内外生物制品标准化工作的进展,阐述了生物制品标准化对生物制品质量管理的重要作用。 With the vigorous development of biotechnology at home and abroad and the continuous expansion of high-tech fields, the importance and role of standardization of biological products have gained the attention of drug regulatory authorities in various countries. China’s biological products standardization work is also in-depth. In this paper, according to the progress of standardization of biological products at home and abroad in recent years, the importance of standardization of biological products to the quality management of biological products is expounded.