医药导报2026，Vol.45Issue(8)：1331-1338,8.DOI:10.3870/j.issn.1004-0781.2026.08.004
国内外药品管理法规政策体系关于药品贮藏规定的对比分析
Comparative Analysis of Drug Storage Regulations in Domestic and International Pharmaceutical Regulatory and Policy Systems
摘要
Abstract
Compliance with drug storage requirements directly affects drug quality,clinical efficacy,and medication safety.Based on a systematic review of China's pharmaceutical regulations and technical guidelines,this study compared international standards from the United States,the European Union,Japan,and the World Health Organization,and analyzed differences in drug storage practices across terminology systems,coverage of environmental factors,regulatory operability,and the guidance function of technical documents.China has established a regulatory framework for drug storage that includes pharmacopoeias,laws,regulations,and technical documents.However,several gaps remain,including insufficient quantitative criteria in terminology,inadequate granularity and enforcement of pharmaceutical regulations and policies,limited research on the prevention of cold chain breaches,and poor readability and instructional value of drug package inserts for patients.Drawing on international experience,future efforts should focus on supplementing multidimensional quantitative parameters in pharmacopoeias,strengthening operational clauses and penalty mechanisms in regulations,improving stability testing and cold chain management in technical guidelines,and promoting the coordinated alignment of regulations,guidelines,and pharmacopoeias.These measures will enhance the scientific rigor,operability,and international alignment of China's drug storage regulations.关键词
药品贮藏/药典/药品管理相关法规政策体系/技术指南/国际比较/冷链管理Key words
Drug storage/Pharmacopoeia/Pharmaceutical regulations and policy systems/Technical guideline/International comparison/Cold-chain management分类
医药卫生引用本文复制引用
李鹤,张伊楠,吴汀溪,杨莉,赵志刚..国内外药品管理法规政策体系关于药品贮藏规定的对比分析[J].医药导报,2026,45(8):1331-1338,8.基金项目
中国药品监督管理研究会立项课题资助项目(2024-Y-Y-005). （2024-Y-Y-005）
