非政府组织在处理登记积压和成本上升问题上不断演变的作用:以南非的癌症生物仿制药为例

IF 0.3 Q4 PHARMACOLOGY & PHARMACY

GaBI Journal-Generics and Biosimilars Initiative Journal Pub Date : 2020-03-15 DOI:10.5639/gabij.2020.0901.004

P. Malherbe

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引用次数: 0

摘要

在世界各地，特别是在低收入和中等收入国家，国家监管当局正在努力应对注册积压和药品的可负担性。本文以南非的癌症生物仿制药为例，说明非政府组织如何通过提供临床需求信息、成本效益分析和洞察通过生物仿制药竞争降低成本的潜力，帮助监管机构决定优先考虑哪些注册申请。

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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An evolving role for non-governmental organizations dealing with registration backlogs and rising costs: the example of cancer biosimilars in South Africa

Around the world, especially in low- and middle-income countries, national regulatory authorities are struggling with registration backlogs and the affordability of medicines. This paper draws on the example of cancer biosimilars in South Africa to illustrate how non-governmental organizations can help regulatory authorities decide which registration applications to prioritize by providing information on clinical need, cost-benefit analysis and insight into the potential for cost reduction through biosimilar competition.

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来源期刊

GaBI Journal-Generics and Biosimilars Initiative Journal PHARMACOLOGY & PHARMACY-

CiteScore

1.80

自引率

0.00%

发文量

期刊介绍： The scope of GaBI Journal is broad and of interest and relevance to professionals active in clinical practice, pharmaceutical science and policy. Materials published in GaBI Journal include high quality research reports, literature reviews and case studies, all of which are peer reviewed. Manuscripts on all aspects of generic and biosimilar medicines, covering areas in clinical, fundamental, technical, manufacturing, bi-processing, economic and social aspects of pharmaceuticals and therapeutics are welcome. In addition, high quality work submitted in other formats, for example, scientific and evidence-based commentaries, may also be considered. In all cases, the emphasis is on quality, originality and knowledge contribution to those involved in health care. All manuscripts submitted to GaBI Journal are subject to a rigorous peer review process. GaBI Journal plans to be indexed in PubMed within two years, and that indexing will be retrospective. GaBI Journal is published quarterly from 2012. All articles are published in English.