A comprehensive regulatory framework to address the unmet need for new antibacterial treatments
A comprehensive regulatory framework to address the unmet need for new antibacterial treatments
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DOI：
10.1016/s1473-3099(12)70293-1
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发表时间：
2013-03-01
影响因子：
56.3
通讯作者：
Jackson, Jennifer
中科院分区：
文献类型：
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作者：
Rex, John H.;Eisenstein, Barry I.;Jackson, Jennifer
将新的抗菌药物推向市场是具有挑战性的，因为发现新的药物是困难的，根据传统的监管要求，每个适应症需要两个大型试验，并且如果新抗生素的使用受到限制，经济回报是有限的。这些挑战导致抗生素管道非常薄弱，尽管对新药的需求迅速和持续增长。平衡注册所需数据量与未满足的医疗需求的方法将鼓励这方面的工作，因此，提出了一个分层监管框架，允许基于疾病或基于病原体的标签适应症，标签措辞促进最适当地使用新药。这一框架在现有监管方法的范围内，适合国际协调，并将是朝着促进强大和可持续的发现和开发基础设施迈出的可喜一步。
To bring new antibacterial drugs to the market is challenging because discovery of new agents is difficult, two large trials per indication are needed in accordance with traditional regulatory requirements, and the economic reward is limited if the use of new antibiotics is constrained. These challenges have resulted in an alarmingly thin antibiotic pipeline, despite the rapid and continued growth in the need for new drugs. Approaches that balance the quantity of data needed for registration with the unmet medical need would encourage work in this are Therefore, a tiered regulatory framework that allows either disease-based or pathogen-based label indications is proposed, with label wording that promotes the most appropriate use of new agents. Such a framework is within the bounds of present regulatory approaches, is amenable to international harmonisation, and would be a welcome step towards the facilitation of a robust and sustainable discovery and development infrastructure.