目的浅析FDA药品注册管理，为我国药品注册管理提供一些借鉴作用。
Objective Analysis of FDA drug registration Managment, and get some insights and suggestions for the improvement of our country's drug registration management.
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.
转让方仅获得《新药证书》的，对照药品的选择应当按照《药品注册管理办法》的规定及有关技术指导原则执行。
In case the transferor did not obtain a drug approval number, the reference drug shall be selected in accordance with the drug Registration Regulation and relevant technical guidelines.
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