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据欧洲医药评估管理署 (ＥＭＥＡ)最新报道 ,在药品上市申请所要求的资料类型方面 ,美国ＦＤＡ与欧洲专利药品委员会 (ＣＰＭＰ)不同。ＦＤＡ批准的许多药品并不能通过ＣＰＭＰ审评。ＥＭＥＡ将所有经统一体系提出的新的完整申请的基本资料汇总 ,以分析影响ＣＰＭＰ评审结果的
According to the latest report of the European Medical Evaluation Agency (EMEA), the FDA differs from the European Medicines Council (CPMP) in terms of the types of data required for drug listing applications. Many FDA-approved drugs do not pass the CPMP review. EMEA summarizes the basic information for all new completed applications submitted under the Harmonized System to analyze the impact of CPMP review results