Compassionate use of medicinal products: a comparison between the European and the United States of America regulatory frameworks.

Q3 Medicine
Arianna Orcesi, Evelina Cattadori, Pilade Cortellazzi, Corrado Confalonieri
{"title":"Compassionate use of medicinal products: a comparison between the European and the United States of America regulatory frameworks.","authors":"Arianna Orcesi, Evelina Cattadori, Pilade Cortellazzi, Corrado Confalonieri","doi":"10.1701/4556.45572","DOIUrl":null,"url":null,"abstract":"<p><p>The treatment of patients suffering from chronic, potentially lethal diseases is a lengthy and disheartening process, especially in cases where patients cannot be satisfactorily treated with authorized medications. In these cases, the only therapeutic option may be experimental drugs. However, in some cases, not all patients meet the inclusion criteria for enrollment in a trial. This problem can be addressed through a \"compassionate use\". Because inadequate information can be a barrier it is essential to clarify the regulatory framework. Despite the availability of reviews, information available on this topic is limited also due to changes in regulations that occur over time. Moreover, the different definitions between states and the lack of a common legislative approach makes the process confusing. The purpose of this article is to compare the legislative frameworks currently in place in European Union and Usa pharmaceutical markets, in order to highlight their strengths, analogies and differences, in a global context that goes beyond the regulatory realities of individual countries.</p>","PeriodicalId":20887,"journal":{"name":"Recenti progressi in medicina","volume":"116 9","pages":"497-501"},"PeriodicalIF":0.0000,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Recenti progressi in medicina","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1701/4556.45572","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"Medicine","Score":null,"Total":0}
引用次数: 0

Abstract

The treatment of patients suffering from chronic, potentially lethal diseases is a lengthy and disheartening process, especially in cases where patients cannot be satisfactorily treated with authorized medications. In these cases, the only therapeutic option may be experimental drugs. However, in some cases, not all patients meet the inclusion criteria for enrollment in a trial. This problem can be addressed through a "compassionate use". Because inadequate information can be a barrier it is essential to clarify the regulatory framework. Despite the availability of reviews, information available on this topic is limited also due to changes in regulations that occur over time. Moreover, the different definitions between states and the lack of a common legislative approach makes the process confusing. The purpose of this article is to compare the legislative frameworks currently in place in European Union and Usa pharmaceutical markets, in order to highlight their strengths, analogies and differences, in a global context that goes beyond the regulatory realities of individual countries.

富有同情心地使用医药产品:欧洲和美利坚合众国监管框架的比较。
对患有慢性、可能致命疾病的病人的治疗是一个漫长而令人沮丧的过程,特别是在病人不能用批准的药物得到满意治疗的情况下。在这些情况下,唯一的治疗选择可能是实验性药物。然而,在某些情况下,并非所有患者都符合纳入试验的标准。这个问题可以通过“富有同情心的使用”来解决。由于信息不足可能成为障碍,因此必须澄清监管框架。尽管有审查,但由于随着时间的推移法规发生了变化,关于这一主题的可用信息也有限。此外,各州之间的不同定义和缺乏共同的立法方法使得这一过程令人困惑。本文的目的是比较欧盟和美国制药市场目前的立法框架,以便在超越个别国家监管现实的全球背景下突出其优势,类比和差异。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 求助全文
来源期刊
Recenti progressi in medicina
Recenti progressi in medicina Medicine-Medicine (all)
CiteScore
0.90
自引率
0.00%
发文量
143
期刊介绍: Giunta ormai al sessantesimo anno, Recenti Progressi in Medicina continua a costituire un sicuro punto di riferimento ed uno strumento di lavoro fondamentale per l"ampliamento dell"orizzonte culturale del medico italiano. Recenti Progressi in Medicina è una rivista di medicina interna. Ciò significa il recupero di un"ottica globale e integrata, idonea ad evitare sia i particolarismi della informazione specialistica sia la frammentazione di quella generalista.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术官方微信