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国内外电子药品说明书使用和监管分析

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随着全球数字化、通信技术的高速发展,网络化新兴技术与医药品行业的快速发展与融合,社会不断老龄化,对电子药品说明书的需求日益强烈,一些国家和地区先后发布了相关法规政策,不断推进电子药品说明书的使用。我国去年也开展了药品说明书适老化及无障碍改革试点,推行电子药品说明书。本文分析了我国和欧美日等国家和地区的电子药品说明书的相关法规和使用现状,以期为我国电子药品说明书推广提供参考。
Supervision and use analysis of electronic pharmaceutical information at home and abroad
With the rapid development of global digitalization and communication technology,the integration and growth of network-based emerging technologies with the pharmaceutical industry are accelerating.As society continues to age,the demand for electronic labeling is growing stronger.Several countries and regions have successively issued relevant regulations and policies,continuously promoting the use of electronic labeling.Last year,China also initiated a pilot reform for the aging-friendly and barrier-free transformation of medication guides,implementing electronic versions.This article sorts out the relevant regulations and current usage of electronic labeling in China,Europe,America,Japan,and other countries,aiming to provide references for the implementation of electronic labeling in China and to explore beneficial references for their application in China.

Electronic pharmaceutical informationRegulationsSupervisesUse

刘宏明、曹森

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山东省食品药品审评查验中心,山东 济南 250013

山东省药品监督管理局,山东 济南 250013

电子药品说明书 法规 监管 使用

2024

药学研究
山东省药品检验所 山东省药学会

药学研究

CSTPCD
影响因子:0.653
ISSN:2095-5375
年,卷(期):2024.43(8)