药品紧急使用授权:历史与伦理困境。

Q2 Medicine Perspectives in Clinical Research Pub Date : 2023-04-01 Epub Date: 2023-04-13 DOI:10.4103/picr.picr_149_22
Mamta Bishnoi, Aniket Sonker
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引用次数: 2

摘要

美国食品药品监督管理局和欧盟的监管审批程序是全世界要求最高、最具挑战性的。他们提供了快速批准途径,即“紧急使用授权”和“有条件上市授权”,分别在紧急情况下批准新型治疗剂。印度根据《2019年新药和临床试验规则》首次正式制定了名为“加速审批流程”的加速途径,以解决中央药物标准控制组织在新冠肺炎期间为批准新型治疗剂而实施的未满足的医疗需求。因此,我们的目标是了解和比较世界上不同的紧急审批流程,它们强调的索赔和条件与这一概念下的批准产品列表。从监管机构的不同官方网站收集和分析的所有信息。在这篇综述中,我们通过其为数不多的获批产品对所有这些流程进行了启发。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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Emergency use authorization of medicines: History and ethical dilemma.

The regulatory approval process of the United States Food and Drug Administration and European Union is the most demanding and challenging worldwide. They have the provision of the expedited approval pathways, i.e., "Emergency use authorizations" and "Conditional marketing authorizations," respectively, to give approval to novel therapeutics agents during emergency situations. India, firstly formalized the accelerated pathway named "Accelerated Approval Process" as per the New Drugs and Clinical Trials rule 2019 to address unmet medical needs that was implemented by the Central Drug Standard Control Organization to approve the novel therapeutics agents during COVID-19. Hence, our aim is to understand and compare the different emergency approval processes in the world, their underlined claims and conditions with the list of approved products under this concept. All the information collected and analyzed from different official websites of regulatory bodies. In this review, we have enlightened on all these processes with their few approved products.

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来源期刊
Perspectives in Clinical Research
Perspectives in Clinical Research Medicine-Medicine (all)
CiteScore
2.90
自引率
0.00%
发文量
41
审稿时长
36 weeks
期刊介绍: This peer review quarterly journal is positioned to build a learning clinical research community in India. This scientific journal will have a broad coverage of topics across clinical research disciplines including clinical research methodology, research ethics, clinical data management, training, data management, biostatistics, regulatory and will include original articles, reviews, news and views, perspectives, and other interesting sections. PICR will offer all clinical research stakeholders in India – academicians, ethics committees, regulators, and industry professionals -a forum for exchange of ideas, information and opinions.
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