一份药物重新利用的监管路线图：比较欧盟、英国和美国使重新利用药物可用的途径。
A Regulatory Roadmap for Repurposing: Comparing Pathways for Making Repurposed Drugs Available In The EU, UK, And US.
作者信息
Scholte Mirre, Bendicksen Liam, Grimm Sabine E, Abu-Zahra Teebah, Pauly Bianca, Joore Manuela, Kesselheim Aaron S
机构信息
DEPARTMENT OF CLINICAL EPIDEMIOLOGY & MEDICAL TECHNOLOGY ASSESSMENT (KEMTA), MAASTRICHT UNIVERSITY MEDICAL CENTRE, MAASTRICHT, THE NETHERLANDS.
CARE AND PUBLIC HEALTH RESEARCH INSTITUTE (CAPHRI), MAASTRICHT UNIVERSITY, MAASTRICHT, THE NETHERLANDS.
出版信息
J Law Med Ethics. 2024;52(4):940-949. doi: 10.1017/jme.2024.171. Epub 2025 Jan 31.
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.
为帮助对药物重新定位感兴趣的学术和非营利研究人员了解监管审批流程，我们比较了重新利用药物在欧洲药品管理局（EMA）、英国药品和医疗产品监管局（UK MHRA）以及美国食品药品监督管理局（US FDA）获得批准的途径。尽管我们没有发现专门针对重新利用药物的途径，但在所有重新利用的情况下都有进入市场的途径。
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