新药方面，仅仅完成18例(2009年是49例)，而仿制药申请的完成量则下降到15例。
Only 18 applications were finalized for new products (down from 49 in 2009) while generics applications dropped to 15.
同样的，2009年该数据也有很大的提高，特别是仿制药申请，启动了38例，完成了51例。
Also in 2009, there was a huge increase in the number of generic MA applications (38 started and 51 finalized).
仿制药申请的的评审官着重于生物等效性资料，化学和生物资料，工厂检查的要求和药品标签信息等。
Generic drug application reviewers focus on bioequivalence data, chemistry and microbiology data, requests for plant inspection, and drug labeling information.
美国通用药物协会的KathleenJaeger补充说很多品牌药公司制作大量的文件申请专利分案“以阻碍仿制药”。
Kathleen Jaeger of America's Generic Pharmaceutical Association adds that branded firms try to extend their lucrative monopolies by filing less rigorous secondary patents designed “to block generics”.
2010年，上市许可申请数据下降的药品包含新药和仿制药，仿制药在完成申请方面下降特别明显。
For 2010, the decline in MA applications encompasses both new products and generics and is particularly marked in finalized applications.
2010年，上市许可申请数据下降的药品包含新药和仿制药，仿制药在完成申请方面下降特别明显。
For 2010, the decline in MA applications encompasses both new products and generics and is particularly marked in finalized applications.
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