Drug Registration

Comparative Study on Chinese and American Procedures of Drug Registration

中、美药品注册管理法规体系的比较研究

Discussion on the Intellectual Property Protection in the Drug Registration Regulations

浅谈《药品注册管理办法》中的知识产权保护

International Drug Registration and New Drug approval in China

国际药品注册和我国的新药审批

OBJECTIVE : To promote the international drug registration for Chinese pharmaceutical enterprises .

前言：目的：促进我国企业原料药的国际注册工作。

New Problems in FDA Problems in Drug Registration

FDA药品注册管理过程中的几个新问题

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

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。

Drug registration is classified into new drug application , supplementary application , license renew application , and import drug application .

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

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。

By comparing domestic and foreign patent protection in the drug registration , Chinas drug patent protection further improvement recommendations are Provided .

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。

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

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。

This certificate can be used by the enterprises for their drug registration transaction in the importing countries , rather than any other purposes .

《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。

Conclusion : Nateglinide tablets prepared with the optimized formulation and technics demonstrated good stability . This study offered preparation study data for the new drug registration .

结论：按照该处方及工艺压制的那格列奈片具有良好的稳定性，本研究为新药报批提供了制剂学研究资料。

To the applicants and relevant research organizations : to ensure the on-site inspection and sampling for drug registration , please make preparations as required below .

为保证药品注册现场核查及抽样工作的顺利开展，请申请单位和相关研究单位按以下要求做好相应准备工作。

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 .

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。

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 .

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。

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 .

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。

Finally , Construct an application management in drug registration of China from the guiding principles , institutional , technological system , staff training , running process in drug registration and so on .

最后从指导原则、机构设置、技术体系建设、人员培训及在我国药品注册中的运行程序等方面构建药物经济学在我国药品注册中的应用管理模式。

Consideration for the guideline to the generic drugs development and review to meet the revised Drug Registration Regulation ; Preliminary analysis of Requirements for On-site Verification for Drug Registration ;

新版《药品注册管理办法》的实施对仿制药研发与技术评价要求的初步考虑浅析《药品注册现场核查管理规定》

The third part is an overview of the provisions of the patent related issues of the Administration of Drug Registration Act , and the existing system and the lack of actual operation .

第三部分主要概述了我国《药品注册管理法》中专利相关问题的规定，和现有制度与实际操作中的不足。

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 .

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。

Chapter 3 : put forward related problems and strategies on the patent in the drug registration , mainly including the quality of paten drugs , the intellectual property rights consciousness of pharmaceutical companies and pharmaceutical patent linkage in China .

第三章，提出我国药品注册中的专利问题及其对策。主要包括药品专利的质量、制药企业的知识产权意识和药品注册的专利链接制度三个方面。

An importer of narcotics and psychotropic drugs shall go through formalities for obtaining of import permit upon strength of imported drug registration certificate as per relevant regulations concerning control of narcotics and psychotropic drugs .

进口麻醉药品、精神药品凭《进口药品注册证》，按照麻醉药品、精神药品管理的有关法规办理《进口准许证》。

The fifth part is how to coordinate the pharmaceutical patent protection and drug registration approval the relationship between some reasonable proposals , including the perfect drug registration management system , and of whether the establishment of drug patent extension system thinking .

第五部分就如何协调药品专利保护与药品注册审批之间的关系提出了一些合理的建议，主要包括完善药品注册管理制度，和对我国是否建立药品专利期延长制度进行了思考。

According to the management methods of drug registration issued from State Food and Drug Administration ( SFDA ), mefenamic acid belongs to the type five new drugs , namely , renewing the formulation while keeping the original administration route .

根据我国药品食品监督管理局（SFDA）通过的《药品注册管理办法》，甲芬那酸分散片属于新药五类，即改变国内已上市销售药品的剂型，但不改变给药途径的制剂。

The second part of the first through the analysis of the relationship between the management of drug registration and patent protection of a link between the two , the difference and cross-impact and coordination to deal with the relationship between philosophy is the principle of the balance of interests .

第二部分首先通过分析药品注册管理和专利保护的关系，阐述了两者的联系、区别及交叉影响，然后分析了协调处理两者的关系理念是利益平衡原则。

Photocopy of the Drug Import Registration Certificate ( or the copy of Pharmaceutical Product Registration Certificate ) and photocopy of the Drug Import Approval ;

《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；

An applicant forges or alters the relevant documents and vouchers ; The Drug Import Registration Certificate ( or the Pharmaceutical Registration Certificate ) has been canceled ;

伪造、变造有关文件和票据的；《进口药品注册证》（或者《医药产品注册证》）已被撤销的；

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

《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

Analysis the Policies about China and USA on New Drug Study and Registration

我国与美国新药创新及注册的相关政策浅析

General consideration element of drug clinical trials for registration

药品注册临床研究的主要考虑因素