目的介绍我国进口药品注册检验工作。
Objective Brief introduce the validation & verification of quality specification of import drug in China.
药品注册审批与专利侵权之间没有必然联系；
There is no necessary association between the registration and approval of drugs and the infringement of patents right.
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.
目前我国药品注册申请人药品说明书起草的质量良莠不齐。
By reviewing the product labeling currently proposed by the new drug applicants, the quality of product labeling seems to vary in different levels.
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.
药品注册分为新药注册申请、补充申请、药品再注册申请和进口药品申请。
Drug registration is classified into new drug application, supplementary application, license renew application, and import drug application.
《药品销售证明书》仅用于企业在进口国办理药品注册手续，不得用于其他用途。
This certificate can be used by the enterprises for their drug registration transaction in the importing countries, rather than any other purposes.
近年来，随着一系列新的药品注册法规的实施，药品的研发与评价较之以往有所不同。
Along with implementing the new policy of drug registration recently, current drug research and evaluation are different from that before.
《进口药品注册证》（或者《医药产品注册证》）复印件、《进口药品批件》复印件；
Photocopy of the Drug Import Registration Certificate (or the copy of Pharmaceutical Product Registration Certificate) and photocopy of the Drug Import Approval;
其他申请人在提出药品注册申请时，应当承诺所有试验数据均为自行取得并保证其真实性。
When applying for drug registration, other applicants shall promise that all the experiment data are independently obtained by themselves and shall guarantee the authenticity of the data.
熟悉药品注册相关信息检索及论坛，能够完成相关项目进展跟踪及相关外文法规检索查询。
Proficiency in drug registration application related database and BBS. Follow on project progress and search related regulation.
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.
通过对比国内外药品注册中的专利保护情况，对我国的药品专利保护的进一步完善提出建议。
By comparing domestic and foreign patent protection in the drug registration, Chinas drug patent protection further improvement recommendations are Provided.
专利纠纷应当按照专利法的相关规定解决，药品注册审批工作不应当涉及药品专利纠纷的解决。
Patent dispute should be solved in accordance with the patent related regulations, the registration and approval of drugs should not involve the solving of patent disputes of drugs.
具有广泛的美国和国际药品注册事务经验，包括成为美国FDA在含量均匀度方面的专家顾问。
And internationally, including serving as an expert advisor to FDA on the issue of content uniformity.
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.
境外申请人办理进口药品注册，应当由其驻中国境内的办事机构或者由其委托的中国境内代理机构办理。
For an overseas applicant, its work office stationed in China or an agency within China commissioned by it shall make the drug registration for it.
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.
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.
方法：分析我国药品注册审批工作中专利相关规定及其存在的问题，并参照美国、欧盟的相关规定进行比较与分析。
METHODS: Regulations and problems in the registration and approval of drugs in China were analyzed and which were compared with that of the American and Europe.
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.
这项计划以未注册商标的药品取代品牌药，在1988年节省了1100万美元。
The programme saved $11 million in 1988 by substituting generics for brand-name drugs.
医生有时开比较便宜的非注册商标的药品，而不开比较昂贵的品牌药。
Doctors sometimes prescribe cheaper generic drugs instead of more expensive brand names.
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.
九月份白宫召开了一次会议，内容是关于如何最好地取缔网上的药品诈骗，会上白宫求助了网络注册商。
The White House turned to Internet registrars when it convened a meeting in September about how best to crack down online pharmaceutical fraud.
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.
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.
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