医药导报2024，Vol.43Issue(5)：745-751,7.DOI:10.3870/j.issn.1004-0781.2024.05.012
国内外政策工具视角下亚硫酸盐类药用辅料及添加剂风险控制措施
Risk Control Measures on Sulfite-based Pharmaceutical Excipients and Food Additives from the Perspective of Domestic and International Policy Tools
摘要
Abstract
Objective To analyze the use of risk control policies for sulfite-based pharmaceutical excipients and food additives in China and abroad,and to provide reference for optimizing policies.Methods Based on the perspective of policy tools,a three-dimensional policy analysis framework of policy tools was constructed,including risk sources,and countries/regions,and the included policy texts were analyzed and coded.Results A total of 101 policy documents with 163 policy item codes were included,which released from 2000 to 2022.In those,compulsory,mixed,and voluntary policy tools accounted for 70.55%,16.56%,and 12.88%,respectively.Conclusions The frequency of policy tools of each type varies greatly,and the structure of used policies is unbalanced.There lack of targeted management policies for sulfite-based pharmaceutical excipients in China.There is no content description of sulfite used in food and drug labels,which is awaited for adjustment.关键词
亚硫酸盐/药用辅料/食品添加剂/政策工具/风险控制/文本量化分析Key words
Sulfite/Pharmaceutical excipients/Food additives/Policy tools/Risk control/Quantitative analysis of text分类
医药卫生引用本文复制引用
李克,朱珺,蔡沅璇,赵宇航,上官小芳,陈哲锐,黄锐,吴健鸿..国内外政策工具视角下亚硫酸盐类药用辅料及添加剂风险控制措施[J].医药导报,2024,43(5):745-751,7.基金项目
药物制剂质量研究与控制重点实验室开放课题资助项目(YWZJZD-202202) （YWZJZD-202202）
湖北省药品监督管理局药品安全监管科研项目(20220112). （20220112）
