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International practice and experience insights of electronic drug instructions
- ZHONGGUO YAOFANG Vol. 35, Issue 17, Pages: 2061-2067(2024)
- 作者机构：
中国药科大学药品监管科学研究院/国家药品监督管理局药品监管创新与评价重点实验室，南京 211198
- 作者简介：
- 基金信息：
DOI：10.6039/j.issn.1001-0408.2024.17.01
CLC： R95Published：15 September 2024，
Received：23 February 2024，
Revised：02 August 2024，
- 稿件说明：
移动端阅览
郑妤婕,蒋蓉,陈艺瑄等.电子药品说明书的国际实践及经验启示 Δ[J].中国药房,2024,35(17):2061-2067.
ZHENG Yujie,JIANG Rong,CHEN Yixuan,et al.International practice and experience insights of electronic drug instructions[J].ZHONGGUO YAOFANG,2024,35(17):2061-2067.
郑妤婕,蒋蓉,陈艺瑄等.电子药品说明书的国际实践及经验启示 Δ[J].中国药房,2024,35(17):2061-2067. DOI： 10.6039/j.issn.1001-0408.2024.17.01.
ZHENG Yujie,JIANG Rong,CHEN Yixuan,et al.International practice and experience insights of electronic drug instructions[J].ZHONGGUO YAOFANG,2024,35(17):2061-2067. DOI： 10.6039/j.issn.1001-0408.2024.17.01.
摘要
目的
2
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
2
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
2
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
2
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
2
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
2
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
Keywords
electronic instructionsreadabilityage-friendly
references
欧军林，李行. 药品说明书说明了什么?[J]. 中国处方药，2004，2（4）：38-45.
OU J L，LI H. What do the drug instructions say?[J]. China Prescr Drug，2004，2（4）：38-45.
ROBERTS K，THAKKAR R，AUTOR D，et al. Creating E-labeling platforms：an industry vision[J]. Clin Pharmacol Ther，2020，108（4）：716-718.
BAMBERGER M，DE LOOF H，MARSTBOOM C，et al. Replacing vaccine paper package inserts：a multi-country questionnaire study on the acceptability of an electronic replacement in different target groups[J]. BMC Public Health，2022，22（1）：156.
THIAGARAJAN S，SHETTY V，CHAUDHARY P. Elabeling for timely and personalized drug information updates to physicians and patients [EB/OL]. [2024-01-10]. https：//globalforum.diaglobal.org/issue/september-2020/elabeling-for-timely-and-personalized-drug-information-updates-to-physicians-and-patients/https://globalforum.diaglobal.org/issue/september-2020/elabeling-for-timely-and-personalized-drug-information-updates-to-physicians-and-patients/.
于巍，貊润翌. 药品电子说明书及其发展现状[J]. 中国新药杂志，2022，31（2）：189-192.
YU W，MO R Y. Electronic drug labeling and its development status[J]. Chin J N Drugs，2022，31（2）：189-192.
FUNG E W T，AU-YEUNG G T F，TSOI L M，et al. Pharmacists’ perceptions of the benefits and challenges of electronic product information system implementation in Hong Kong：mixed-method study[J]. J Med Internet Res，2020，22（11）：e20765.
孙奇，郝继英，马骏涛，等. Drugs@FDA、FDA Online Label Repository和DailyMed三大开放获取药品说明书数据库的比较研究[J]. 中国药房，2018，29（1）：131-134.
SUN Q，HAO J Y，MA J T，et al. Comparative study on three open access drug label databases：Drugs@FDA，FDA online label repository and DailyMed[J]. China Pharm，2018，29（1）：131-134.
宋飞，黄玲，马南顺，等. 美国药品标识监管体系研究[J]. 中国药事，2018，32（3）：367-377.
SONG F，HUANG L，MA N S，et al. Study on FDA regulatory system of drug labeling[J]. Chin Pharm Aff，2018，32（3）：367-377.
NAGAOKA M，TAKAMINE T. E-labeling system in prescription medicines in Japan：measures and perspectives in pharmaceutical industry[J]. Transl Regul Sci，2022，4（1）：12-19.
龙之朱. 药品说明书字那么小，“清晰易辨”吗?[J]. 民生周刊，2023（13）：8.
LONG Z Z. Is the drug instruction so small that it is “clear and easy to distinguish”?[J]. Minsheng Weekly，2023（13）：8.
唐菀晨，顾淼. 浅谈电子药品说明书[J]. 中国食品药品监管，2023（9）：98-103，186.
TANG W C，GU M. Discussion on electronic drug instructions[J]. China Food Drug Adm Mag，2023（9）：98-103，186.
国家药品监督管理局. 国家药监局关于发布药品说明书适老化及无障碍改革试点工作方案的公告[EB/OL]. （2023-10-31）[2024-01-10]. https：//www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20231031153424162.htmlhttps://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20231031153424162.html.
NMPA. Notice of NMPA on issuing the tasks for pilot reform of the age-friendly and barrier-free drug instructions[EB/OL]. （2023-10-31）[2024-01-10]. https：//www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20231031153424162.htmlhttps://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20231031153424162.html.
国家药监局药审中心. 国家药监局药审中心关于发布《药品说明书（简化版）及药品说明书（大字版）编写指南》和《电子药品说明书（完整版）格式要求》的通告[EB/OL]. （2023-11-24）[2024-01-10]. https：//www.cde.org.cn/main/news/viewInfoCommon/fbe67f9737e40e062cf5770-727d81d71https://www.cde.org.cn/main/news/viewInfoCommon/fbe67f9737e40e062cf5770-727d81d71.
CDE of NMPA. Notice of NMPA on Issuing The Guidance for Drug Instructions （Simplified Version） and the Preparation of Drug Instructions （Large Print Version） and The Guidance for Electronic Instructions of Drug （Simplified Version）[EB/OL].（2023-11-24）[2024-01-10]. https：//www.cde.org.cn/main/news/viewInfoCommon/fbe67f9737e40-e062cf5770727d81d71https://www.cde.org.cn/main/news/viewInfoCommon/fbe67f9737e40-e062cf5770727d81d71.
EMA. Electronic product information for human medicines in the EU：key principles[EB/OL]. （2020-01-29）[2024-01-10]. https：//www.ema.europa.eu/en/electronic-product-information-human-medicines-european-union-key-principleshttps://www.ema.europa.eu/en/electronic-product-information-human-medicines-european-union-key-principles.
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