药品注册标准，是指国家食品药品监督管理局批准给申请人特定药品的标准，生产该药品的药品生产企业必须执行该注册标准。
9.3 药品注册标准（Drug Registration Specifications） 31 9.4 药品标准物质（Drug Reference Standards） 32
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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.
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.
本研究的目的就是按照国家《药品注册管理办法》的要求建立中药新药银翘胶囊质量标准。
The objective of this research is developing a quality standard of Yinqiao capsule based on the national regulation.
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