Department of Medicinal Chemistry, Experimental Therapeutics Programme, Centro Nacional de Investigaciones Oncologicas (CNIO), C/ Melchor Fernandez Almagro, 3, 20029 Madrid, Spain.
Future Med Chem. 2009 Apr;1(1):35-48. doi: 10.4155/fmc.09.8.
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.
美国食品和药物管理局（FDA）和欧洲药品管理局（EMEA）每年批准的新医疗实体数量的减少，一直是制药行业争论的焦点。本文将分析 2007 年 FDA 和 EMEA 批准的所有新药申请（NDAs），旨在寻找可以用来预测未来趋势的规律（同时也回顾过去）。在对监管术语进行了一般性介绍之后，本文将 2007 年的 NDA 批准分为几类（旧药的新应用、代谢物、对映异构体和前药、生物制品、天然产物和小分子新分子实体）并进行了讨论。本文还概述了 NDA 批准的一般方面，如历史趋势、药物发现过程的长短、地理位置、治疗领域的差异，以及生物技术和制药行业的相对作用。通过对这些分析，我们对一些可能影响未来药物批准的方面有了一定的了解。结论是，就新批准药物的质量而言（如果不是数量的话），2007 年可能代表了一个转折点，未来可能比之前预期的更加光明。
