摘要
目的 分析国内外亚硫酸盐类药用辅料和食品添加剂风险控制政策的使用情况,为优化政策提供参考意见。方法 基于政策工具视角,构建政策工具-风险来源-国家/地区的三维政策分析框架,对纳入政策文件进行分析和编码。结果 共纳入政策文件101份,政策条目编码163条,政策发布年份为2000—2022年。强制性、混合性、自愿性政策工具分别占70.55%、16.56%、12.88%。结论 各类型政策工具内部使用频数差异大,使用结构不均衡。我国对亚硫酸盐类药用辅料缺少针对性管理政策,在食品药品标签无含量说明,有待调整。
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.
作者
李克
朱珺
蔡沅璇
赵宇航
上官小芳
陈哲锐
黄锐
吴健鸿
LI Ke;ZHU Jun;CAI Yuanxuan;ZHAO Yuhang;SHANGGUAN Xiaofang;CHEN Zherui;HUANG Rui;WU Jianhong(NMPA Key Laboratory for Quality Research and Control of Drug Products,Wuhan Institute for Drug and Medical Device Contro,Wuhan 430073,China;School of Pharmacy,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430030,China;School of Statistics and Mathematics,Zhongnan University of Economics and Law,Wuhan 430073,China)
出处
《医药导报》
CAS
北大核心
2024年第5期745-751,共7页
Herald of Medicine
基金
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)
湖北省药品监督管理局药品安全监管科研项目(20220112)。
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
Sulfite
Pharmaceutical excipients
Food additives
Policy tools
Risk control
Quantitative analysis of text
