药品注册管理办法

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 .

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

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 .

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 ;

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 .