Survey Result for E-labeling Initiatives in Asia

Author:

Matsui RieORCID,Yamaguchi Koji,Lee Jadz Jevz Venzon,Ting Ivy,Khairilisani Destita,Chang Jenny,Seo Jeong-Min,Park Ina,Chee Alice Seat Mee,Quizon Paul Marvin,Harnpramukkul Usanee,Sem Ellen,Nguyen Thuy,Padhye Anagha,Mo Runyi

Abstract

AbstractUnder the COVID-19 pandemic, various electronic labeling initiatives have accelerated worldwide in the healthcare and pharmaceutical fields as part of a wider digital transformation [1, 2]. Although there is no universal definition of electronic labeling (e-labeling) globally, it is widely understood that e-labeling refers to the product information that is distributed via electronic means. There are 5 factors to be considered in e-labeling, and these are discussed in this publication. APAC is an industry-driven initiative with 13 R&D-based pharmaceutical associations joining from 11 markets in Asia. e-labeling was discussed as a new topic starting in 2020, and a 22-question survey was conducted in November 2021 to understand the current e-labeling status. The survey results showed that e-labeling initiatives were at different levels of maturity in the Asian region, although most markets have started to discuss e-labeling initiatives. Various challenges exist around e-labeling initiatives due to a variety of different approaches being taken in the region. It would be advisable to develop regional guidance on how to proceed with e-labeling initiatives in the Asian region to have a consistent and efficient approach. The close collaboration between agencies, Health Care Professionals (HCPs), patients, and industry associations is important to move e-labeling initiatives forward in Asia.

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Public Health, Environmental and Occupational Health,Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

Reference26 articles.

1. Roberts K, et al. Creating E-Labeling Platforms: An Industry Vision. Clin Pharmacol Ther. 2020;108(4):716–8.

2. Bamberger, et al. Replacing vaccine paper package inserts: a multi-country questionnaire study on the acceptability of an electronic replacement in different target groups. BMC Public Health. 2022;22:156.

3. PFSB/SD Notification No. 0411–1, PFSB/ELD Notification No. 0411–2, Risk Management Plan Guidance 11-Apr-2012,

4. EMA Guideline on good pharmacovigilance practices (GVP) Module V – Risk management systems (Rev 2) https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-module-v-risk-management-systems-rev-2_en.pdf

5. PMDA wordings for Guides for patients https://www.pmda.go.jp/safety/info-services/drugs/items-information/guide-for-patients/0001.html, https://www.pmda.go.jp/files/000225751.xlsx

Cited by 1 articles. 订阅此论文施引文献 订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献

1. Publisher Correction: Survey Result for E-labeling Initiatives in Asia;Therapeutic Innovation & Regulatory Science;2022-10-31

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3