摘要
目的介绍了人用药品注册规范化文件的编写格式。方法全面介绍通用技术文件(CTD)的具体章节内容和写作格式。结果与结论对有意打开国际市场的我国制药企业编写规范的注册文件起到指导作用,推动我国制药企业的国际化进程。
Objective To present the preparation of common technical document （CTD） for the registration of pharmaceuticals for human use. Methods A comprehensive introduction to the contents of each chapter and layout of CTD was made. Results and Conclusion The article can be a guide to help Chinese manufacturers who want to enter international market to prepare CTD for the registration of pharmaceuticals, which will promote the globalization of Chinese pharmaceutical industry.
出处
《中国药事》
CAS
2012年第5期526-528,共3页
Chinese Pharmaceutical Affairs
关键词
通用技术文件
药物主文件
国际协调会议
国际药品注册
Common Technical Document （CTD）
Drug Master File （DMF）
InternationalConference of Harmonization （ICH）
international pharmaceutical registration
