对于已有国家标准的药品，可只检测系统适用性试验。
As for national standard drugs, system suitability shall be tested only.
已有国家标准药品的申请，是指生产已经由国家药品监督管理局颁布的正式标准的药品注册申请。
Application for drugs with existing state standards shall refer to the application for registration of the drugs for which the SDA has promulgated official standards.
申请已有国家标准的药品注册，一般不需要进行临床研究。
Generally, it is not necessary to conduct clinical study for the application for registration of drugs with existing state standards.
结果：研制的氟罗沙星葡萄糖注射液符合已有的国家标准，是一种安全、有效、质量可控的药品。
Results: Development Fleroxacin and Glucose injection conforms to already the national standards which has, is one kind of security, effective, the quality controllable drugs.
背景已有国家标准中成药的申请注册(简称中药仿制)正成为药品研发领域的热点。
BACKGROUNDTraditional Chinese medicine (TCM) imitation is becoming the hot spot of research and development field.
背景已有国家标准中成药的申请注册(简称中药仿制)正成为药品研发领域的热点。
BACKGROUNDTraditional Chinese medicine (TCM) imitation is becoming the hot spot of research and development field.
应用推荐