| 人用药品注册技术要求国际协调会议关于通用技术文件的协调进展及其启示 |
| |
| 引用本文： | 黄洁,邱家学.人用药品注册技术要求国际协调会议关于通用技术文件的协调进展及其启示[J].药学服务与研究,2005,5(4):349-352. |
| |
| 作者姓名： | 黄洁 邱家学 |
| |
| 作者单位： | 中国药科大学国际医药商学院,南京,210009 |
| |
| 摘 要： | 本文旨在遵从药品注册技术要求一致化的原则下,对人用药品注册技术要求国际协调会议(ICH)所倡导执行的通用技术文件(CTD)进行比较全面的阐述和理解,详细介绍CTD在ICH6上的进展情况,就美国食品药品监督管理局对CTD的实施过程予以简介和研究,并深入探讨其对于我国药品注册规范等方面的影响和启示。
|
| 关 键 词： | 通用技术文件 人用药品注册技术要求国际协调会议 规范 国际协调 |
| 文章编号： | 1671-2838（2005）04-0349-04 |
| 收稿时间： | 2005-03-21 |
| 修稿时间： | 2005-07-28 |
International harmonization and enligtenment of the Common Technical Document under the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use |
| |
| HUANG Jie,QIU Jia-Xue.International harmonization and enligtenment of the Common Technical Document under the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use[J].Pharmaceutical Care and Research,2005,5(4):349-352. |
| |
| Authors: | HUANG Jie QIU Jia-Xue |
| |
| Abstract: | According to the standard principle of drug registeration,this paper is written to expatiate on the Common Technical Document(CTD) which is inspired and energized by International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use(ICH).The development of CTD at the ICH6 and the process of implementation of CTD by FDA are summarized.The impact on China registration of pharmaceuticals for human use is(thoroughly) discussed. |
| |
| Keywords: | Common Technical Document International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use standardization international harmonization |
| 本文献已被 CNKI 维普 万方数据 等数据库收录！ |
