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电子药品说明书的国际实践及经验启示
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| 篇名： | 电子药品说明书的国际实践及经验启示 |
| TITLE： | International practice and experience insights of electronic drug instructions |
| 摘要： | 目的 分析欧盟、美国、日本的电子药品说明书实践情况，为推进我国现有法律法规体系下电子药品说明书的实施提供建议。方法通过检索美国FDA官网、欧洲药品管理局（EMA）官网、日本医药品医疗器械综合机构（PMDA）官网及相关文献，比较分析上述国家/地区的电子药品说明书实践情况及制度特点；同时，分析我国电子药品说明书法律基础、可访问形式、监管体系方面存在的问题，并提出建议。结果与结论欧盟、美国、日本为推行实施电子药品说明书设立了相关法律，并发布指导原则细化管理要求、工作进程，搭建信息平台，规范数据要求，丰富检索途径。相比之下，我国正初步开展电子药品说明书实践，其推行实施仍缺少立法支持，可访问形式和未来监管体系的构建方式也有待进一步探索。建议我国以开展药品说明书适老化及无障碍改革试点工作为契机，完善电子药品说明书法律法规体系，分阶段探索其可访问形式以提高药品说明书可读性，建立健全电子药品说明书监管体系，积极搭建药品说明书信息化平台，推进电子药品说明书的开发与实施。 |
| 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. |
| 期刊： | 2024年第35卷第17期 |
| 作者： | 郑妤婕；蒋蓉；陈艺瑄；李海琦；袁思晗；邵蓉 |
| AUTHORS： | ZHENG Yujie，JIANG Rong，CHEN Yixuan，LI Haiqi，YUAN Sihan，SHAO Rong |
| 关键字： | 药品说明书；电子说明书；可读性；适老化 |
| KEYWORDS： | drug instructions； electronic instructions； |
| 阅读数： | 8 次 |
| 本月下载数： | 1 次 |
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