中国药房2024，Vol.35Issue(17)：2061-2067,7.DOI:10.6039/j.issn.1001-0408.2024.17.01
电子药品说明书的国际实践及经验启示
International practice and experience insights of electronic drug instructions
摘要
Abstract
OBJECTIVE To analyze the practices of electronic drug instructions in the European Union(EU),the United States(US)and Japan,so as to provide references for promoting electronic drug instructions under Chinese existing regulatory systems.METHODS By searching the official websites of FDA,European Medicines Agency(EMA)and Pharmaceuticals and Medical Devices Agency(PMDA),as well as relevant literature,the practice and system of electronic drug instructions in different countries/regions were compared and analyzed.The problems of regulatory system,accessibility form and management system of electronic drug instructions in China were analyzed to put forward the suggestions.RESULT&CONCLUSIONS The EU,the US and Japan had established relevant laws for the implementation of electronic drug instructions,issued guidance to specify management requirements and work processes,and set up information platforms to standardize data requirements and enrich search channels.In contrast,the practice of electronic drug instructions in China is still in its infancy,the implementation of electronic drug instructions in China still lacks legislative support,and its accessibility form and future regulatory system need to be further explored.It is suggested to take the opportunity to carry out the pilot reforms of the age-friendly and barrier-free environment for drug instructions in China,improve the regulatory system of electronic drug instructions,promote the readability of drug instructions by exploring the accessibility form of electronic drug instructions in stages,establish and improve the regulatory system of electronic drug instructions,actively build an electronic information platform for it,and promote the development and implementation of electronic drug instructions.关键词
药品说明书/电子说明书/可读性/适老化Key words
drug instructions/electronic instructions/readability/age-friendly分类
医药卫生引用本文复制引用
郑妤婕,蒋蓉,陈艺瑄,李海琦,袁思晗,邵蓉..电子药品说明书的国际实践及经验启示[J].中国药房,2024,35(17):2061-2067,7.基金项目
国家自然科学基金项目(No.72304280) （No.72304280）
