药品注册

FDA药品注册管理过程中的几个新问题

New Problems in FDA Problems in Drug Registration

FDA管理药品注册和备案系统的药品代码数据库并在药品代码目录中发布摘录信息。

FDA maintains the repository of NDC numbers in its Drug Registration and Listing System ( DRLS ) and publishes an extract of this information in its NDC Directory .

浅谈WTO与中国的药品注册

A Brief Discussion on Registration of Chinese Drugs After Admission of China into WTO

浅谈WTO与中国的药品注册药品注册审批工作中专利相关问题探讨

A Brief Discussion on Registration of Chinese Drugs After Admission of China into WTO Solving Patent Problem in the Registration and Approval of Drugs

欧盟药品注册、企业生产许可证及GMP检查的相互关系

Relationship Among Drug Marketing Authorization , Manufacturing Authorization as Well as GMP Inspection

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 .

他们持有中药生产执照和GMP执照，是外国药品注册的基本条件。

They are holding CPM manufacturing and GMP licences , which are necessary for registration of their products in overseas .

为了促进穿心莲GAP基地的发展和满足临床用药需要，本课题按照药品注册管理办法有关技术要求，对穿心莲内酯原料药及其新制剂进行了研究。

In order to improve the development of the GAP base and fulfil the demand of clinical medication , we have done a comprehensive research on the andrographolide and its preparation according to Examining and Approving Method of Medicine .

所用的试剂安全无毒，得到的产品的纯度高、品质优，符合GMP、药品注册管理办法和中国药典2005版的要求，可作为食品添加剂中间体和单体药原料使用。

Use solvent and reagent is innocuity safety . Quality and purity of obtained product is good . Accord standard of GMP medicine registration administer method and 2000 Edition China pharmacopoeia , It may be used in the food additive and material of medicine .

药品注册申报已经从纸制品走向电子化，电子常规技术文件（eCTD）标准提交的软件产品也层出不穷。

Drug registration application has been from paper products to electronic , eCTD submission standards for software products are endless .

我国非专利药品注册问题之我见

Viewpoint on the Problem of Registration for Non - patent Drug

浅谈《药品注册管理办法》中的知识产权保护

Discussion on the Intellectual Property Protection in the Drug Registration Regulations

《中华人民共和国药品注册管理办法》新法规与原法规技术要求的比较

New technical requirements of new drug in the registration provisions in China

中、美药品注册管理法规体系的比较研究

Comparative Study on Chinese and American Procedures of Drug Registration

新修订的《药品注册管理办法》对过去界定宽泛的“新药”进行了更严格的规定。

The rules have also been tightened on previously loosely-defined'new drugs ' .

国际药品注册和我国的新药审批

International Drug Registration and New Drug approval in China

药品注册临床研究的主要考虑因素

General consideration element of drug clinical trials for registration

已有国家标准化学药品注册检验中发现的问题及建议

Problems and Proposals Found in The Registration Test of National Drug Standards ' Medicine

高文庄，药品注册部的前任头头，同样也被拘捕。

Cao Wenzhuang , former head of the drug-registry division , has also been detained .

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 .

按照《药品注册管理办法》中药、天然药物注册分类5的要求，进行了乳香提取物药理毒理试验研究。

With reference of " Drug registration and management approach ", the pharmaceutical and toxic test were conducted .

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 .

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 .

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 .

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 .

对于关键性法律进行分析，得出的结论是：我国药品注册中专利链接制度有漏洞。

By analyzing the critical legal issues , we come to the conclusion that there are some loopholes in pharmaceutical patent linkage .

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 .

自2007年《药品注册管理办法》颁布后，国家提高了新药和仿制药的申报标准。

Since The Provisions for Drug Registration Published in 2007 , our country raised the reporting standards of new drug and generic drug .

《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 ;

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 .