Recent drug approvals from the US FDA and EMEA: what the future holds
Recent drug approvals from the US FDA and EMEA: what the future holds
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DOI：
10.4155/fmc.09.8
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发表时间：
2009-04-01
影响因子：
4.2
通讯作者：
Pevarello, Paolo
中科院分区：
文献类型：
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作者：
Pevarello, Paolo
美国FDA和欧洲药品管理局（EMEA）每年批准的新医疗实体方面的制药行业生产力下降长期以来一直存在争议。本综述将分析2007年FDA和EMEA批准的全部新药申请（NDA），目的是发现趋势（也关注过去），以预测未来。在对监管术语进行一般性介绍后，将2007年NDA批准分为类别（旧药、代谢物、对映体和前药、生物制品、天然产物和有机小分子新分子实体的新应用）并进行讨论。还概述了NDA批准的一般方面，如历史趋势、药物发现过程的长度、地理位置、治疗领域之间的差异以及生物技术和制药行业的相对作用。从这个分析中，获得了一些方面的观点，可能会影响未来的药物批准。结论是，2007年可能是一个转折点，就新批准的质量而言，如果不是数量的话，未来可能比以前预测的更光明。
The decreased productivity of the pharmaceutical industry in terms of new medical entities approved by the US FDA and the European Medicines Agency (EMEA) on a yearly basis has long been debated. This review will analyze overall new drug applications (NDAs) approved by both the FDA and EMEA in 2007, with the aim of finding trends (also looking at the past) that can be used to predict what the future may be. After a general introduction to the regulatory terminology, NDA approvals in 2007 are divided into categories (new applications of old medicines, metabolites, enantiomers and prodrugs, biological products, natural products and small organic molecule new molecular entities) and discussed. General aspects of the NDA approvals, such as historical trends, the length of the drug-discovery process, geography, differences among therapeutic areas, and the relative role of biotech and pharma industries are also outlined. From this analysis, a perspective is gained on some aspects that will probably influence future drug approvals. The conclusion is that 2007 may represent an inflexion point, in terms of quality if not quantity of new approvals, and that the future may be brighter than previously forecast.