中国标准化Issue(10)：92-98,7.DOI:10.3969/j.issn.1002-5944.2026.10.013
生物药产业国际标准化研究
Research on International Standardization of Biopharmaceutical Industry
摘要
Abstract
This article briefly introduces the main international standards organizations in the biopharmaceutical industry,studies the current and revised major international standards for biopharmaceuticals,analyzes the development trends of international standards for biopharmaceuticals in the International Organization for Standardization(ISO),the World Health Organization(WHO),and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use(ICH),and proposes suggestions for continuously adopting standards,strengthening full process management,building a multi-level standardization talent system,and deeply participating in the governance of international standards organizations.These suggestions provide standard technical support for China's biopharmaceutical industry to align with international standards and provide useful references for deep participation in international standardization work for biopharmaceuticals.关键词
生物药/国际标准/标准化/ISO/WHO/ICHKey words
biopharmaceuticals/international standards/standardization/ISO/WHO/ICH引用本文复制引用
樊哲,汤梓斌,叶美君,李山,臧兴杰,罗湘建..生物药产业国际标准化研究[J].中国标准化,2026,(10):92-98,7.基金项目
本文受广东省自然科学基金面上项目"基于案例推理的养老服务风险评估关键技术与风险防控规范化"(项目编号:2020A1515010689) （项目编号:2020A1515010689）
广东省市场监督管理局科技项目"智慧家电产业知识产权服务标准化研究"(项目编号:2025CB01)资助. （项目编号:2025CB01）
