中國(guó)制藥企業(yè)藥品國(guó)際注冊(cè)策略研究.pdf

1、對(duì)外經(jīng)濟(jì)貿(mào)易大學(xué)碩士學(xué)位論文中國(guó)制藥企業(yè)藥品國(guó)際注冊(cè)策略研究姓名：程瑤申請(qǐng)學(xué)位級(jí)別：碩士專業(yè)：工商管理指導(dǎo)教師：周煊20080401Abstract Pharmaceutical Industry has very big scales in China, but Chinese pharmaceutical industry is not very strong in the world. Globalization of Chin

2、ese pharmaceutical companies go very slowly because our drug registration can not be approved by authorization of United States and EU. We can not sell our drug with our own label attached on the drug. Generally, drug re

3、gistration regulations in China are not as strict as those in United States and EU. This Assay mainly focuses on the research of categories and characteristics of drug registration in United States and EU, and of the imp

4、ortance of ICH guidelines and common technical documents. So we can see the obstacles in the drug registration in United States and EU. In this article, several cases of Chinese pharmaceutical companies registering their

5、 drugs in United States and EU are mentioned and strategies on how to solve the problems are given. Five recommendations are concluded from their experiences as reference for drug registration of Chinese pharmaceutical c