我国药品说明书信息公开制度的健全与完善  

Establishment and perfection of information disclosure system of drug labeling in China

作　　者：郑妤婕 蒋蓉[1,3] 陈艺瑄 李海琦 袁思晗 邵蓉 ZHENG Yu-jie;JIANG Rong;CHEN Yi-xuan;LI Hai-qi;YUAN Si-han;SHAO Rong(Institute of Regulatory Sciences,China Pharmaceutical University,Nanjing JIANGSU 211198,China;Mudi Meng Honors College,China Pharmaceutical University,Nanjing JIANGSU 211198,China;NMPA Key Laboratory for Drug Regulatory Innovation and Evaluation,Nanjing JIANGSU 211198,China)

机构地区：[1]中国药科大学药品监管科学研究院,江苏南京211198 [2]中国药科大学孟目的学院,江苏南京211198 [3]国家药品监督管理局药品监管创新与评价重点实验室,江苏南京211198

出　　处：《中国新药与临床杂志》2025年第3期168-174,共7页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：药品说明书信息公开对建立健全药品管理工作机制和信息共享制度、保障公众用药安全具有重要意义。欧盟、美国、日本通过明确药品说明书信息公开主体、建设药品说明书信息公开平台、统一药品说明书信息上传下载的途径和格式等举措,形成了较为完善的药品说明书信息公开机制。我国已建立有药品说明书信息公开体系,但药品说明书信息公开程序和信息公开平台建设尚不成熟。建议我国可通过明确信息公开主体和公开形式、完善系统性信息检索平台、健全信息准入程序和信息更新维护机制等举措,提高药品说明书信息的可及性。The information disclosure of drug labeling is of great significance to establish and improve the drug administration work mechanism and the information-sharing system,and to protect drug safety of the public.By clarifying the subject of information disclosure on drug labeling,constructing a platform for information disclosure of drug labeling,as well as standardizing the methods and formats for uploading and downloading the information of drug labeling,a more complete mechanism for information disclosure of drug labeling has been formed in the European Union,the United States,and Japan.China has established the information disclosure system for drug labeling,but the information disclosure procedures and platform construction for drug labeling are still not mature.It is suggested that China should improve the accessibility of drug labeling by clarifing the subject and the form of information disclosure,improving the systematic information retrieval platform,and perfecting the information access mechanism and information update procedures.

关 键 词：药品说明书 信息公开 电子药品说明书 

分 类 号：R95[医药卫生—药学]