这些产品不必需要新药上市申请。
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.
如果制药公司希望标记OT C但没有达到专著要求的，均可以提交新药上市的申请和获得注册新药的许可。
Companies wishing to market OTC drugs that do not meet the monograph requirements can submit and receive approval of a new drug application.
如果制药公司希望标记OT C但没有达到专著要求的，均可以提交新药上市的申请和获得注册新药的许可。
Companies wishing to market OTC drugs that do not meet the monograph requirements can submit and receive approval of a new drug application.
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