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.
美国美华公司在纳斯达克上市，提供中国市场分析、临床实验管理、产品注册、市场研究以及面向医院的药品分销等服务。
BMP is listed on Nasdaq and offers pre-market entry analysis for China, clinical trial management, product registration, market research, and pharmaceutical distribution to hospitals.
第七条国家规定并由国家工商行政管理局公布的人用药品和烟草制品，必须使用注册商标。
Article 7 Registered trademarks must be used on the pharmaceuticals for human use and tobacco products prescribed by the State and announced by the State Administration for Industry and Commerce.
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.
分析了申报原料药的管理和质量控制中存在的问题，简述了药品注册中原料药管理和质量控制的几点建议。
This article analyses the common problems in the registration application and quality control of drug substance, and gives some suggestions for the issues concerned.
分析了《药品注册现场核查管理规定》的出台对药品注册现场核查工作可能产生的影响，对《规定》中的一些内容进行了探讨。
The new SFDA regulation: Requirements for on-site verification for Drug Registration was analyzed and the impact to present work of on-site verification was concluded.
提议的修订对目前药品组织必须注册和对药品备案的管理以及要提交的内容将重新组织和细化。
The proposed revisions would also reorganize and clarify current regulations concerning which drug establishments must register and list their drugs with FDA and what information they must submit.
食品与药品管理局已经接受该公司的新药申请并将文件归档，而且还组织了处方药物使用权行动，活动目标是将公司新药注册日期定在2008年一月二十三日。
The FDA has accepted the Company's NDA for filing and has set a Prescription Drug User Fee act (PDUFA) target action date for the Company's NDA of January 23, 2008.
公司是拥有自主进出口经营权幷在美国食品药品管理局注册登记的国际贸易公司。
It is an international trading company which has been registered in U. S. FDA and has the right to operate import and export enterprises.
公司是拥有自主进出口经营权幷在美国食品药品管理局注册登记的国际贸易公司。
It is an international trading company which has been registered in U. S. FDA and has the right to operate import and export enterprises.
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