药品注册管理

FDA药品注册管理过程中的几个新问题

New Problems in FDA Problems in Drug Registration

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 .

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 ' .

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 .

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 .

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 .

中国发布了新的药品注册管理办法，从而改革其景况不佳的药品监管系统，并促进创新。

China has created new regulations for the registration and management of drugs in a bid to reform its ailing drug regulatory system and boost innovation .

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》

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 ;

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。

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 .

方法从药品注册管理和技术审评的角度，按照安全有效、质量可控的注册要求，研究探讨药物制剂药学研究的基本要求和内在规律，设计各个研究阶段的基本项目和规范要求。

METHODS From the points of drugs registration management and technical appraisal , and according to the request which safe effective and the quality is controllable , we research the basic request and inherent law of pharmaceutical preparation and design the elemental term and inherent law of each research stage .

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。

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 .

美国、欧盟、中国对兽用生物制品、兽用药品产品注册的管理从管理机构、法律依据到注册材料的要求都不尽相同。

There are many different administrant regulations of veterinary biological and drug products licensing authorization in the United States of America , EU and China .

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 .

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 .

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。

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 .

2001年12月1日开始实施修订的《药品管理法》和我国加入WTO的新形势，对中国的药品注册管理制度又带来新的机遇与挑战。

Owing to the implementation of the revised Law of Drug Management , which began from December 1,2001 and to the new situation emerging after China admitted into WTO , new opportunities and challenge will come up before the system of drug registration and management of the country .

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。

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 .

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。

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 .