重新利用的监管路线图：欧盟、英国和美国重新利用药物的途径比较

IF 1.6 4区哲学 Q2 ETHICS

Journal of Law Medicine & Ethics Pub Date : 2024-01-01 Epub Date: 2025-01-31 DOI:10.1017/jme.2024.171

Mirre Scholte, Liam Bendicksen, Sabine E Grimm, Teebah Abu-Zahra, Bianca Pauly, Manuela Joore, Aaron S Kesselheim

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引用次数: 0

摘要

为了帮助对药物再利用感兴趣的学术和非营利研究人员了解监管审批流程，我们比较了再利用药物在EMA、英国MHRA和美国FDA获得批准的途径。虽然我们没有发现药物再利用的特殊途径，但在所有再利用的情况下都有进入市场的途径。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文本刊更多论文

A Regulatory Roadmap for Repurposing: Comparing Pathways for Making Repurposed Drugs Available In The EU, UK, And US.

To help academic and non-profit investigators interested in drug repurposing navigate regulatory approval processes, we compared pathways for repurposed drugs to obtain approval at EMA, UK MHRA, and the US FDA. Though we found no pathways specifically for repurposed drugs, pathways to market are available in all repurposing scenarios.

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来源期刊

Journal of Law Medicine & Ethics 医学-医学：法

CiteScore

2.90

自引率

4.80%

发文量

审稿时长

6-12 weeks

期刊介绍： Material published in The Journal of Law, Medicine & Ethics (JLME) contributes to the educational mission of The American Society of Law, Medicine & Ethics, covering public health, health disparities, patient safety and quality of care, and biomedical science and research. It provides articles on such timely topics as health care quality and access, managed care, pain relief, genetics, child/maternal health, reproductive health, informed consent, assisted dying, ethics committees, HIV/AIDS, and public health. Symposium issues review significant policy developments, health law court decisions, and books.