中国药房2011，Vol.22Issue(25)：2311-2313,3.
我国新药生产市场准入制度的相关问题研究
Relevant Problems of New Drug Manufacture Market Access System in China
杨莉 1陈玉文 1连桂玉1
作者信息
- 1. 沈阳药科大学工商管理学院,沈阳市110016
- 折叠
摘要
Abstract
OBJECTIVE: To improve new drug manufacture market access system in China. METHODS: This paper started the research from the meaning, mode and the main content of market access system, and made deep analysis on the current situation, main problems and the reason of the new drug manufacture market access system in China, using literature research and comparative research methods. RESULTS & CONCLUSIONS: There are many problems about non-standard legal system and multiple access procedures, low approval efficiency, manufacturing license bound with registered number of approval, and duplication of production permit and GMP verification, etc. We should learn the successful experiences from US and other countries to improve it. It is suggested to take registration system for manufacturers, implement GMP product certification, and introduce MAH system.关键词
新药/生产/市场准入/建议Key words
New drug/Manufacture/Market access/Suggestion分类
医药卫生引用本文复制引用
杨莉,陈玉文,连桂玉..我国新药生产市场准入制度的相关问题研究[J].中国药房,2011,22(25):2311-2313,3.
